Close to 677 million people in India required treatment against tropical diseases such as dengue, chikungunya, and snakebite envenoming in 2021, yet global research about these ailments continues to be heavily underfunded compared to illnesses such as HIV/AIDS. These diseases are termed as Neglected Tropical Diseases (NTDs) by the World Health Organization (WHO).
NTDs primarily affect populations in tropical and subtropical regions, and they have historically received less attention and fewer resources. The affected populations are typically among the poorest in the world. These diseases contribute to a cycle of poverty, as they cause long-term disability, social stigma, and economic burden, which in turn hinders economic development and attracts less commercial investment in treatments and research. They also lead to other health problems such as anaemia, blindness, chronic pain, infertility and disfigurement.
Chart 1 |The chart shows the annual research and development funding for NTDs in 2022 ($, adjusted for inflation). Research and development for NTDs (blue) have been historically underfunded compared to diseases like HIV/AIDS, tuberculosis, and malaria.
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The COVID-19 pandemic received a total research funding of $4.22 billion in 2022. HIV/AIDS, tuberculosis and malaria received funding in the range of $600 million to $1.35 billion that year. Whereas, diseases such as dengue, chikungunya, leprosy and snakebite envenoming received funding in the range of $10 million to $80 million.
Map 2 |The map shows the estimated number of people requiring treatment against NTDs in 2021.
With 677 million people requiring treatments, India tops the charts followed by Nigeria with 139 million, Indonesia with 79 million, Ethiopia with 71 million and Bangladesh with 56 million. Congo, Philippines, Tanzania, Uganda and Pakistan are the other nations in the top ten list. The geographic spread clearly shows that most of the disease burden in the case of NTDs is shouldered by countries in Asia and Africa. Mexico is the only non-Asian, non-African country with a higher share of burden featuring high (14th) on the list. Deaths due to NTDs in Europe, Oceania and North America (except Mexico) are few and far between.
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India tops the charts in terms of dengue deaths with 17,500 such fatalities recorded in 2019. India also tops the charts in leprosy cases with over one lakh cases in 2022. With over 50,000 deaths due to venomous snakes in 2019, the mortality in India is much higher than the distant second Pakistan (2,000 fatalities).
Chart 3 |The chart shows the technologies on which the global research and development funding for infectious diseases was spent.
Most of the global research funding was focused on finding vaccines to counter COVID-19. A sharp increase in vaccine funding to the tune of $5.2 billion was recorded in 2020. In 2022, research funding dropped across all technologies including vaccines. Research money for new drugs, basic research, biologicals and diagnostic platforms declined in 2022.
A lot can be done to alleviate the health burden caused by NTDs. Many can be managed with inexpensive existing interventions or new technologies developed through research. However, these diseases still suffer from a lack of adequate funding, research and development, and global attention. The success of certain initiatives demonstrates what can be achieved with deliberate effort. Examples include the near-eradication of Guinea worm disease and the elimination of river blindness, lymphatic filariasis, and trachoma in many countries.
Also read:Indias health research is not aligned with its disease burden | Data
Baseline regression
Table 2 reports the baseline regression results of the influence of the publics science literacy level on co-production in the fight against COVID-19. With the test logic of econometrics starting from the general to the specific cases, a series of control variables were gradually included in the regression model.
Model (1) only included the core explanatory variables without the addition of any control variables, and the science literacy was significantly positive at 1%. In model (2), six control variables at the objective level of the city were added based on (1), and the science literacy was still significantly positive at 1%. On the basis of (2), model (3) further included three subjective control variablessuch as the publics government trust in the modeland the science literacy was still significantly positive at 1%, consistent with the results of the previous two regression steps. The determination coefficient increased from 0.38 to 0.59, and the fitting degree was thus improved. This indicated that the higher the level of the citys science literacy, the more the co-production against the pandemic. The coefficient of science literacy gradually increased from 0.117 to 0.142, indicating that science literacys influence was increasingly apparent. Model (3) demonstrates that every 1% increase in the publics science literacy can increase the per capita search volume of COVID-19-related keywords by the public by 14.2%, that is, public co-production against the pandemic increased by 14.2%, which verifies H1.
To further address the potential endogeneity problem in the model, a 2SLS model was used to accurately estimate the impact of public science literacy on the public co-production, with the ratio of urban R&D personnel to the annual average population in 2017 as the instrumental variable.
As demonstrated in Table 3, (1) and (2) reported the results of the two-stage regression with the instrumental variable. The regression results of the first stage (1) indicated that the regression coefficient of the proportion of R&D personnel in the city was significantly positive at the 1% level, which denoted that the higher the ratio of urban R&D personnel in the city, the higher the publics science literacy in the city. The correlation hypothesis of the instrumental variable is valid. Meanwhile, the partial R2 is 0.32, and the F-statistic of the significance test is 32.68. The instrumental variable has strong explanatory power. The results of the second stage (2) regression demonstrated that after addressing the endogeneity problem, the positive influence of the publics science literacy on co-production was still significantly positive at 1%. Specifically, with the increase of science literacy by 1%, public co-production increased by 42.5%, which was about three times that of the baseline regression result, which indicated that the promoting effect of the publics science literacy on co-production during COVID-19 may be underestimated due to the endogeneity problem. It was verified that science literacy contributes to promoting co-production against the pandemic. Thus, H1 is supported.
To test the moderating effect of regional educational levels, the proportion of urban secondary school students (Edu_c) was used to measure educational level. The intersection term of regional education level and science literacy was added into the regression model, along with a series of control variables. As illustrated in Table 4, no control variables were added to model (1); only objective control variables were added to model (2), and subjective control variables were further added to model (3). The results demonstrated that the coefficient of the intersection term gradually increased from 0.471 to 1.049, and the significance level gradually rose. The intersection term of model (3) was significantly positive at the 5% level, and the determination coefficient was 0.69, which was better than that of model (3). The coefficient of the interaction term gradually increased from 0.038 to 0.046, and the significance level gradually increased; the determination coefficient increased from 0.51 to 0.62, and the degree of fitting was improved. Model (3) illustrated that the intersection term was significantly positive at the 5% level.
Similar to the approach for testing the moderating effect of regional education level, the number of discredited people (Capacity_c) of the city was used to measure the local government capacity. The greater the number, the worse the local government capacity. As demonstrated in models (4), (5), and (6), the coefficient of the interaction term gradually decreased from 0.009 to 0.020, and the significance level gradually became higher. The interaction term of the model (6) was significantly negative at 1% level.
Figure 3 shows the separate plotting of the moderating effects of regional education level and local government capacity on the publics scientific literacy and co-production in the fight against COVID-19. In the left graph, when Edu_c is greater than 0, the marginal effect is significantly positive within the 95% confidence interval. This means that the marginal effect of the publics science literacy on co-production of fight against COVID-19 gradually increases with the increase of the proportion of the number of students in the city. In the figure on the right, when Capacity_c is <11.77 (The natural logarithmic value of 129,000 is about 11.7, so the number of discredited people at the provincial level in the city is 129,000), the marginal effect is significantly negative within the 95% confidence interval. This means that when the number of provincial-level discredited people in the city is less than 129,000, the marginal effect of the publics science literacy on co-production in the fight against the pandemic gradually increases as the number of discredited people decreases.
Controls were applied for GRP, income level, science and technology level, number of foundations, government network transparency, digital government development level, publics government trust, social trust, and social justice. The dashed line was at a marginal effect of zero. Full regression estimates are provided in Table 4 models with 95% confidence interval.
Both the regression results and the moderating effect graphs indicate that the level of urban education and the local government capacity have a positive impact on the effectiveness of the publics science literacy in promoting co-production fight against COVID-19, supporting hypothesis H2 and H3.
Whether the baseline regression results are affected by sample selection needs to be further tested. As demonstrated in Table 5, owing to a small number of outliers in the explained variables, the explained variables in models (1) and (2) were, respectively, treated with bilateral tail reduction and bilateral censoring at the 5% quantile to avoid the deviation of coefficient estimation, and all control variables were added to perform regression estimation. Additionally, this study further replaced the data and the publics science literacy at the city level with those at the provincial level and added all control variables, as demonstrated in the model (3). Clearly, the coefficients of science literacy are all significantly positive at 1% level, and the baseline regression results are still robust.
The results of the baseline regression are the embodiment of the total effect, and the unique properties of different stages and regions may affect the manifestation of science literacy. This section analyzes the heterogeneity of the stage of the pandemic, geographical location, and city size in terms of the two dimensions of time and space.
With the continuous development of the pandemic situation, the external conditions and the publics willingness in co-production may change. To further explore the dynamic changes of the publics anti-pandemic efforts, this section studies separate regression testing across all stages - including Stage I: Swift Response to the Public Health Emergency (27 December 201919 January 2020), Stage II: Initial Progress in Containing the Virus (20 January20 February 2020), Stage III: Newly Confirmed Domestic Cases on the Chinese Mainland Drop to Single Digits (21 February17 March 2020), and Stage IV: Wuhan and Hubei-An Initial Victory in a Critical Battle (18 March28 April 2020); various models that joined all control variables.
As demonstrated in Table 6, the science literacy coefficients of stages I, II, III, and IV were 0.160, 0.132, 0.152, and 0.160, respectively; they were all significantly positive at 1% level, which indicated that the publics science literacy to the pandemic was effective in all stages. The science literacy coefficient first decreased and then increased. The science literacy coefficient was the same in stages I and IV, and the promoting effect of science literacy on the co-production was relatively obvious, which indicated that the promoting effect of the publics science literacy in different stages was different. In general, the promoting effect of science literacy was statistically significant in the whole process of the fight against the pandemic in each stage, which further verified the correctness of H1.
China is a country with vast territory, and heterogeneity in different regions will affect the publics willingness and cost of co-production in response to the pandemic. The sample cities, based on different characteristics in different geographical locations, were classified into three subregions: eastern, central, and western regions. Specifically, the eastern region includes cities in Beijing, Tianjin, Hebei, Liaoning, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong, and Hainan; the central region includes cities in Shanxi, Jilin, Heilongjiang, Henan, Hubei, Hunan, and Anhui; the western region includes cities in Inner Mongolia, Chongqing, Sichuan, Guangxi, Guizhou, Yunnan, Shaanxi, Gansu, Qinghai, Ningxia, and Xinjiang. Thereafter, subsample regression was performed. All control variables were added to each model.
As demonstrated in Table 7, models (1), (2), and (3) reflect the differences in the publics anti-pandemic effort based on scientific knowledge in the cities across regions. The science literacy coefficients of cities in eastern, central, and western regions were 0.141, 0.250, and 0.193, respectively, and all of them were significantly positive at 1%, which further supported H1. The estimated coefficient of 0.141 in the eastern region was smaller than that in the central and western regions. It is reasonable to suspect that the promoting effect of the publics science literacy is smaller in the eastern region and relatively larger in the central and western regions.
To answer the aforementioned questions, we further explore the differences between regions. By adding the intersection terms of regional dummy variables and science literacy (E_MS_L, E_WS_L, and E_MWS_L), the difference test of regression coefficient between eastern and central, eastern and western, and eastern and central and western regions, was conducted. The results demonstrated that the coefficients of the interaction terms were all significantly positive, which indicated that a statistically significant difference existed in the coefficient of science literacy between the eastern region and other regions, and the science literacy in the central and western regions played a more evident role in the promotion of the public co-production against the pandemic.
The size of a city affects the difficulty of urban governance and challenges the level of governmental governance. Unlike small and medium-sized cities, large cities are more difficult to govern due to their large population, complicated public affairs, and diverse service demands, and various problems will become more prominent. On the contrary, larger cities have stronger incentives to innovate management models with refined management, improved institutional norms, diversified technical means, and higher enthusiasm of the public to participate in urban governance (Zou and Zhao, 2022). Therefore, the scale of the city may also affect the effectiveness of the role of the publics science literacy in co-production, and still the role of science literacy in the promotion of co-production in those cities is not known. In China, the urban hierarchy is relatively complex, mainly consisting of municipalities directly under the central government, provincial capital cities, sub-provincial cities, prefectural level cities and county-level cities. In comparison to most prefectural level cities, municipalities directly under the central government, provincial capital cities, and sub-provincial cities possess unique advantages in terms of economy, politics, culture, and population. In this paper, they are referred to as large cities, including Beijing, Tianjin, Shanghai, Chongqing, Dalian, Qingdao, Ningbo, Xiamen, Shenzhen, Shijiazhuang, Shenyang, Nanjing, Hangzhou, Fuzhou, Jinan, Guangzhou, Haikou, Taiyuan, Changchun, Harbin, Zhengzhou, Wuhan, Changsha, Hefei, Nanchang, Hohhot, Chengdu, Nanning, Guizhou, Kunming, Xian, Lanzhou, Xining, Yinchuan, Urumqi, Lhasa, a total of 36 cities, and all the rest cities are considered non-large cities. Therefore, this paper divided the sample into two subsamples according to aforementioned categorization; large city, and non-large city; and conducted the subsample regression, after adding all the control variables.
As demonstrated in Table 8, models (1) and (2) reflect the differences in the publics co-production based on science literacy in cities of different scales. The science literacy coefficient of large cities was 0.082, and the significance level was 5%. The science literacy coefficient of non-large cities was 0.260, with a significance level of 1%, which also supported H1. The estimated coefficient of 0.082 for large cities was about one-third of that for non-large cities.
To further verify the statistical significance of the difference in the promotion effect of science literacy, the intersection term (L_CityS_L) was added to the model to test the difference. The results demonstrated that the coefficient of the interaction term was significantly positive, indicating that the promoting effect of science literacy on co-production against COVID-19 was stronger in non-large cities but weaker in large cities.
The above results provide us with many interesting findings. The publics science literacy plays an important role in promoting co-production in the fight against pandemic, and there are significant differences in the performance of the effect of this role in different temporal and spatial dimensions. We also found that regional education level and local government capacity can positively moderate the relationship between the two, verifying the previous hypotheses H1, H2, and H3.
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The optimal response to a pandemic requires immediate and well-integrated action that includes, implementation of containment measurements, identification of the causative infectious agent, generation of specific diagnostics, and rapid development, authorization and roll-out of safe and effective therapeutics and vaccines. As demonstrated during the COVID-19 pandemic, prevention of disease by vaccination is crucial to reduce hospitalisation, mortality, and disruption of the healthcare system. Recently developed vaccine technologies like the messenger RNA (mRNA) vaccines proved to be most impactful since they paired short development and production timelines with high levels of protection. These vaccines have saved millions of lives and have been key in allowing the re-opening of society after a series of lockdowns.
Wide use of these vaccines was based on a clear positive benefit-risk balance, not only for the most vulnerable subjects prone to develop severe COVID-19, like the elderly and people with specific co-morbidities, but also for healthy individuals including those at young age. COVID-19 vaccines are very safe, nevertheless close safety monitoring post authorization resulted in the prompt identification of very rare adverse reaction events that were thoroughly assessed by EMA Pharmacovigilance Risk Assessment Committee (PRAC), and regulators worldwide. Among these, myocarditis and pericarditis cases emerged as very rare adverse events almost exclusively following immunisation with mRNA vaccines. These rare vaccination-associated disease manifestations could only be discovered post-authorisation since due to their low frequency they could not be identified earlier, not even in large trials involving tens of thousands of volunteers.
Pericarditis is a swelling and irritation of the tissue surrounding the heart (pericardium) and is usually mild and resolves without treatment. Myocarditis is an inflammation of the cardiac muscle (myocardium), which can reduce the ability of the heart to pump blood. In addition to immune activation due to e.g., autoimmunity and exposure to drugs (check-point inhibitors)1 these conditions have been linked to several viral infections2 including infection with SARS-CoV-23 and also to vaccines, like live attenuated virus smallpox vaccines4. More recently pharmacovigilance surveillance and observational studies across the globe have pointed at an increased risk of myocarditis in predominantly younger males post administration of the two COVID-19 mRNA vaccines, Comirnaty and Spikevax, and also after vaccination with the adjuvanted protein-based vaccine Nuvaxovid and the adenovirus vector-based vaccine Jcovden5,6,7,8. Most cases of vaccine associated myocarditis are mild, transient, and self-limiting. However, occasionally, as with myocarditis caused by viral infection, chronic myocarditis and dilated cardiomyopathy might develop which can result in congestive heart failure and may even be fatal in very rare occasion9.
The efforts in collecting pharmacoepidemiology data to define incidence across populations are ongoing. The pathophysiology remains undefined and many disease mechanisms have been postulated10,11. The research data on the disease mechanism available are scarce and a definitive mechanism for the pathogenesis of this adverse event post vaccination is far from being established. In this manuscript we summarize the main pharmacoepidemiology data and highlight recent findings on the pathophysiology of COVID-19 vaccine associated myocarditis. We reflect on the information shared during an ad hoc workshop organized by the European Medicines Agency (EMA) and identify research areas important to improve our understanding of the pathophysiology of this very rare adverse event12. A better understanding of the disease mechanism leading to myocarditis upon vaccination is crucial for the design and use of improved next generation vaccines.
After the global COVID-19 vaccine rollout, the initial reports of a higher than expected number of myocarditis and pericarditis cases following mRNA vaccination emerged already in FebruaryMarch 2021 from Israel13, Spain and the US. Within a few months also other countries reported increased rates (above the background incidence rate) of myocarditis and pericarditis after mRNA vaccination. The rapid identification by pharmacovigilance systems globally was followed by a prompt addition of a myocarditis and pericarditis warning to the product information of Comirnaty, Spikevax vaccines and later on, Nuvaxovid5,6,7 and Jcovden vaccines8. Data for Vaxzevria was reviewed by the PRAC and was considered insufficient to conclude on causal association, also noting that evidence from the literature was conflicting, with some studies14,15,16,17 showing a modest association whereas others did not18,19,20. For Spikevax and Comirnaty, the frequency of myocarditis and pericarditis has been listed as very rare (<1 in 10,000), while for Nuvaxovid and Jcovden it cannot be estimated from the data available so far, as more data are needed to further characterize the risk.
Identification of clinical manifestations of myocarditis is essential for accurate diagnosis and case management. In this context, the most used case definitions for myocarditis are taken from the US CDC11 and the Brighton Collaboration, and some epidemiological studies report on myocarditis by using the European Society of Cardiology diagnostic guidelines. These definitions largely overlap and all incorporate several types of evidence, such as clinical signs/symptoms, electrocardiogram, blood tests, imaging and histopathology, with the positive histopathological findings being regarded as gold standard for the diagnosis. Cardiac MRI is mostly used due its high sensitivity and non-invasive nature, however it is not being used very often for mild cases.
Before COVID vaccines were deployed and administered, it was reported that patients with COVID-19 have approximatively 16 times the risk for myocarditis relative to patients without COVID-193. Matched analyses from medical records (Dec 2020 to May 2021) from the largest health care organization in Israel21 showed that COVID-19 vaccination was associated with an elevated risk of myocarditis (risk ratio, 3.24) compared to unvaccinated and SARS-CoV-2 infection was associated with a substantially increased risk of myocarditis (risk ratio, 18.28) compared to uninfected. It was also noted that a significant lower mortality rate was observed among individuals with myocarditis after mRNA vaccination when compared to those with a viral infectionrelated myocarditis21,22. In line with these results, a more recent study showed that the relative risk of heart failure within 90 days was 0.56 and 1.48 for myocarditis associated with vaccination and COVID-19 disease, respectively23. In summary, compared with myocarditis associated with COVID-19 disease, myocarditis after vaccination with SARS-CoV-2 mRNA vaccines occurs less frequent and in addition is associated with a better clinical outcome23. However, the accurate background incidence rate in healthy people and the actual number of vaccine associated cases are overall difficult to determine, and are most likely under-estimated, as many cases resolve without an actual diagnosis or assistance by healthcare providers and estimating the extent of potential under-reporting in the pharmacovigilance systems still remains a challenge as it may be influenced by numerous factors, including public awareness, the disease severity spectrum, demographics, and/or local practices.
At present, more than three years after licensing of the COVID-19 vaccines in the EU/ European Economic Area, it has been established that the highest risk of developing myocarditis is in males aged 1230 years, within 114 days post vaccination after the second dose of the primary series of vaccination with an mRNA vaccine. Following post approval recognition of the increased risk to develop myocarditis upon mRNA COVID-19 vaccination, many large often nationwide or even global population studies revealed this risk distribution14,16,24,25,26,27,28,29,30. Two large European studies provided estimates of the number of excess cases of myocarditis after the second dose of mRNA vaccine in young vaccinees (below 30 years) compared to unexposed: 0.26 (French national health data system) and 0.57 (Nordic registry data) per 10,000 for Comirnaty, 1.3 and 1.9 per 10,000, respectively, for Spikevax24. For children aged 511 years, the US CDC has reported that myocarditis after mRNA COVID-19 vaccination is much rarer, with only slightly elevated rates above the anticipated background rates31. Importantly, myocarditis has not been reported among children aged 6 months5 years32. Also for adults above 30 and the elderly, only slightly elevated myocarditis rates have been observed upon COVID-19 vaccination2. The US CDC has been following patients aged 1229 years affected by myocarditis for at least 90 days after symptom onset and reported that for most of these the overall quality of life returned to pre-pandemic levels or were fully recovered as per health care provider assessment33. Of the 393 patients with biomarkers and/or imaging findings, 7794% returned to normal or baseline values22,31,33.
It has been documented that classical viral infectionrelated myocarditis is more frequently observed in male than female individuals, from childhood through young adulthood, while women are affected mostly at the postmenopausal age34, which suggests that certain predisposing factors related to age and sex may contribute to the development of myocarditis post infection as well as to post-vaccination.
The vaccine dosing interval could also impact the risk of developing myocarditis post vaccination. In this regard, a study from Canada demonstrated that the extended interval of 8 weeks as compared with a 34 weeks interval between mRNA vaccine doses 1 and 2 was associated with a reduced risk of myocarditis and pericarditis particularly among male individuals aged 1824 years25. Furthermore, in Canada the highest reported incidence was observed among male adolescents aged 1617 years after dose 2 (15.7 per 100,000) and the reporting rate was highest in those with a short (ie, 30 days) dose interval (21.3 per 100,000)26. Similarly, a French pre-print study indicated that for both the Comirnaty and the Spikevax vaccine longer intervals between each consecutive dose may decrease the occurrence of vaccine-associated myocarditis35 in line with a study performed in Hong-Kong also demonstrating that extended intervals between the first and second dose of the Cormirnaty vaccine reduces the risk of myocarditis with 29 percent in vaccinees aged 517 years36. In view of these data, some countries, i.e., Australia, Canada, UK, decided to extend the interval, 812 weeks, between primary course doses specifically for the very high risk group, 1217 years old.
The risk to develop myocarditis upon administering mRNA booster doses has also been studied. Several studies have shown that the risk to develop myocarditis after a booster dose remains elevated but this risk is consistently lower than the risk after the second dose of the primary vaccination27,29,37.
It will be relevant to understand if this pattern holds true also with repeated booster vaccinations with updated COVID-19 vaccines.
mRNA vaccines were the first COVID-19 vaccines to be authorized, distributed, and administered at an unprecedented large scale, while adeno-vectored and protein-based vaccines were authorized subsequently and administered at a smaller scale in the EU/European Economic Area. Initial meta-analysis comparing the risk associated to immunization with these respective vaccines suggested a higher incidence of myocarditis after receiving an mRNA vaccine vs a non-mRNA (adeno-vectored) vaccine2, however this analysis should be updated with data including more recently authorized vaccines. Among the mRNA vaccines, individual studies suggested a higher incidence of myocarditis after a second dose of Spikevax compared to Comirnaty16,38.
Studies on myocarditis associated with COVID-19 vaccination are hampered by several limitations such as: the absence of reliable estimates of the clinically suspected myocarditis frequency in the population prior to COVID19 pandemic, as well as lack of a systematic collection of endomyocardial biopsies to support the confirmation of the diagnosis, especially for clinically mild cases in which collecting biopsies is not warranted. Of note, usually biopsies are not taken, and MRI is not performed in clinically mild cases.
In a study specifically including recently (20 days) COVID-19 vaccinated individuals that died unexpectedly9, it was shown that most of these cases displayed an inflammatory infiltration of the epicardium and the subepicardial fat tissue. This infiltrate was characterized by an identical T cell-dominant immunophenotype and interspersed macrophages. An acute arrhythmogenic cardiac failure was postulated due to the limited pathology observed. No causal association with COVID-19 vaccination can be asserted from this study, but the authors suggested that CD4+T cells are the main drivers of heart-specific autoimmunity in myocarditis39. Additional research is required to assess the relevance of the results obtained.
The U.S. Centers for Disease Control and Prevention (CDC) has recommended updated vaccines for the fall to protect against common respiratory diseases. Among the changes: people age 75 and older should get vaccinated against RSV, the COVID-19 vaccine will target a new strain of the virus, and the updated flu shot will include only three strains instead of the four in last year's shot. It made these changes after a committee that advises the CDC recommended them.
"Our top recommendation for protecting yourself and your loved ones from respiratory illness is to get vaccinated," said CDC director Dr. Mandy Cohen in a statement supporting the new advice.
Here's what to know about the shots you might needand what's different from past guidance.
Older adults and young babies are at highest risk for respiratory syncytial virus (RSV), and last year, vaccines became available for the former group for the first time. The advisory committee at the time recommended that anyone age 60 or older talk to their doctors about whether they should get an RSV shot. This year, it went further, saying that people 75 and older should get vaccinated.
Those who are 60 to 74 should get the vaccine only if they didn't last year and are at higher risk of RSV, the committee decided. (The RSV shot is not currently an annual vaccination.)
But they didn't recommend it for younger adults. Earlier this year, the U.S. Food and Drug Administration (FDA) approved GSKs RSV vaccine for people 50 and up; however, the committee declined to recommend the shot for that age group, citing the risk of Guillain-Barre syndrome, a condition in which the bodys immune system attacks nerves. While the incidence of the syndrome among those who are vaccinated is small, the risk of RSV complications in younger people is also lowso the risk-benefit calculations dont obviously favor vaccination, at least for now.
The committee discussed the current outbreak of H5N1 avian influenza (also known as bird flu) in dairy cattle. The risk of bird flu in people remains low, according to the CDC scientists presenting the latest data to the advisory committee, so no vaccination plans were adopted. The CDC is preparing, however, to make decisions about vaccination if cases start spreading among people.
Read More: We Are Not Safe from Bird Flu Until We Protect Farmworkers
In the current outbreak, three peopleall dairy workershave tested positive for H5N1. Agency scientists said that existing vaccines that are part of the national emergency stockpile, and two vaccine candidates the CDC is testing, are effective in protecting against the circulating version of H5N1.
As expected, the committee unanimously voted to recommend the seasonal flu vaccine for everyone age six months and older. The update targets three strains, including a new one, H3N2, that will likely circulate in coming months.
The decision about whether to recommend COVID-19 vaccination for the upcoming season wasnt as straightforward as it has been in previous years, when the SARS-CoV-2 virus caused more cases and fewer people had immunity against it. But now that almost every has either been exposed to the virus, vaccinated against it, or both, COVID-19 doesnt have the same health impact on the population as it once did. Even though the virus is mutating into different variants, longer-lasting immunity based on T cells appears to be protecting most people from severe disease and deathwhich raises the question of how critical a yearly vaccine will continue to be.
However, the CDC provided data showing that the risk of severe COVID-19 remains significant for older people, especially those over 75, who account for most of the hospitalizations and deaths due to the disease. Among younger people, the risk is higher for those with underlying health conditions. But for other healthy adults, the risk-benefit calculations are shifting.
Read More: The Isolation of Having Long COVID as Society Moves On
We are not thinking here about whether the vaccine protects absolutely, as we did when we had a [COVID-19] nave population," said Ruth Link-Gelles, a CDC epidemiologist and its vaccine effectiveness program lead, at the committee meeting. "We are thinking, in a population that already has some immunity, what [protection] can we give beyond that? She noted that even if the yearly vaccine will always lag behind the currently circulating strain of SARS-CoV-2 because the virus mutates so quickly, a vaccine that reduces the risk of severe disease by 40% to 50% among those at high risk of COVID-19 complications can be important. It may not be the 95% [reduction] we were seeing in the early days, but we also dont need that level of protection, because we are looking to increase protection in people who already have existing protection, she said.
That's important, since data show that every encounter with COVID-19 can increase the risk of developing Long COVID, and that people who are vaccinated can reduce their risk of Long COVID.
One option the group considered was making a recommendation for high-risk people, rather than a universal recommendation for everyone six months and older to get vaccinated. But committee members expressed concern that the potentially confusing guidance about who should get vaccinated may lead to even an lower immunization rate than the current one; only about 20% of eligible people received the updated COVID-19 vaccine in 2023. In data cited by the CDC from a survey conducted by the agency with University of Iowa and the RAND Corporation, nearly half of physicians surveyed said they did not bring up COVID-19 vaccinations at appointments because they felt their patients would not be interested in getting immunized.
It can feel very frustrating, says Dr. Jen Brull, president-elect of the American Academy of Family Physicians, who is not a committee member. But I still think that family physicians everywhere feel that its our responsibility to offer important preventive and and other chronic health treatments.
In the end, the committee voted unanimously to continue recommending a COVID-19 shot for everyone six months and older. The FDA recently recommended updating the shot to target a newer strain, JN.1a move that the CDC also supports. For the coming season, two of the shots will be based on mRNA technology, from Moderna and Pfizer-BioNTech, and one, from Novavax, will be protein-based and include a portion of the COVID-19 virus spike protein.
Immunization Activities and Coverage
During the reporting period, 28 SIAs using OPV type 2 (OPV2) or IPV were conducted, including seven national immunization days, 12 subnational immunization days, and nine smaller, targeted campaigns. Twelve SIAs occurred in 2021, six in 2022, eight in 2023, and two in early 2024. Vaccines used included monovalent Sabin-strain OPV2 (mOPV2) (15 SIAs), novel OPV2 (nOPV2, further attenuated version of Sabin mOPV2 with enhanced genetic stability) (eight), tOPV (three), and IPV (two). During 20172020, 17 bOPV campaigns were conducted.
Among 1,921 children aged 659 months with nonpolio AFP reported during January 2017March 2024, caretakers reported that 730 children (38%) had received 3 OPV doses through routine immunization, and that 538 (28%) had received 1 IPV dose; 1,364 (71%) children had received 3 OPV doses during SIAs. Overall, 231 (12%) children with nonpolio AFP were reported to have received no OPV doses through routine immunization or SIAs (i.e., zero-dose children); among these children, 219 (95%) were from districts in the South-Central region and 139 (60%) whose accessibility status was recorded were from inaccessible districts. As of December 2023, an estimated 472,743 children (representing 17% of children in Somalia aged <5 years) remain unreached for vaccination in the South-Central region because of security reasons (Figure 1).
As of March 2024, the Somalia AFP surveillance system comprised 983 active surveillance sites and included a total of 796 village polio volunteers situated in all regions; 71% of these volunteers are in districts in the South-Central region. During 20172024, Somalias national nonpolio AFP rate consistently reached or exceeded three cases per 100,000 persons aged <15 years per year (annual range during 20212024=3.85.2). However, Banadir, the state reporting the highest number of cVDPV2 cases, consistently missed this target (range=1.82.9) (Table).
The 80% stool specimen adequacy target was met each year during 20172023 (annual range=92.4%99.1%) and in each state except Galmudug (72.2%) in the first quarter of 2024. However, the proportion of stool specimens that arrived at the WHO-accredited laboratory in Kenya within the recommended 3 days after collection decreased from 44% in 2017 to 9% in 2022 and 2023.
During January 2017March 2024, a total of 73 cVDPV2 isolates were detected across four of the six states with ES sites; Banadir state accounted for 66 (90%) detections. Collection sites in Somalia increased from four in 2017 to 17 in 2023.
cVDPV2 cases. During 20172024, 39 cVDPV2 cases were reported from all seven states, including 34 (87%) from districts in the South-Central region (Figure 2) (Supplementary Table, https://stacks.cdc.gov/view/cdc/157501) (Village accessibility survey, WHO Somalia, unpublished data, 2024). The remaining five cases were reported from Somaliland (four) and Puntland (one) during 20192020. Overall, the mean age of patients was 36 months (range=3108 months) and 49% were female. Among the 39 cVDPV2 patients, 20 (51%) reportedly had received zero routine immunization or SIA OPV doses.
cVDPV3 cases. In 2018, states Hirshabelle and Jubbaland reported five and two cVDPV3 cases, respectively (Figure 2). Among these cases, three patients had received no routine immunization or SIA OPV doses, and four had received >3 SIA doses. No cVDPV3 has been isolated since September 2018.
In 2017, genomic sequence analysis of circulating cVDPV2 strains indicated protracted circulation of the SOM-BAN-1 cVDPV2 emergence occurred 3 years before detection. The most recent case in this emergence group was detected in Jubbaland in March 2024. During January 2021March 2024, 17 (59%) of 29 isolates were detected in Banadir, including 10 of 16 orphan viruses, which indicates substantial gaps in surveillance.
In December 2023, a second cVDPV2 emergence (SOM-BAY-1) was identified in southern Somalia and was most recently detected in January 2024. In addition, a cVDPV2 isolated from an ES sample collected in Banadir in May 2022 was from the Yemen cVDPV2 emergence group YEM-TAI-1; no further detections have occurred in Somalia to date.
WASHINGTON (AP) The Supreme Court on Monday rejected a challenge to a 2021 Connecticut law that eliminated the states longstanding religious exemption from childhood immunization requirements for schools, colleges and day care facilities.
The justices did not comment in leaving in place a federal appeals court ruling that upheld the contentious law. A lower court judge had earlier dismissed the lawsuit challenging the law, which drew protests at the state Capitol.
Connecticut law requires students to receive certain immunizations before enrolling in school, allowing some medical exemptions. Prior to 2021, students also could seek religious exemptions. Lawmakers ended the religious exemption over concerns that an uptick in exemption requests was coupled with a decline in vaccination rates in some schools.
The change allowed current students in K-12 who already had a religious exemption to keep it.
This is the end of the road to a challenge to Connecticuts lifesaving and fully lawful vaccine requirements, Democratic Attorney General William Tong said in a statement. We have said all along, and the courts have affirmed, the legislature acted responsibly and well within its authority to protect the health of Connecticut families and to stop the spread of preventable disease.
Brian Festa, vice president and co-founder for the group We The Patriots USA Inc., a lead plaintiff in the case, called the decision disappointing but said its not the end of the road for us in our fight to win back religious exemptions for schoolchildren.
The group which has challenged other vaccination laws, including for COVID-19 had argued along with several parents that Connecticut violated religious freedom protections by removing the exemption. The new law shows a hostility to religious believers and jeopardizes their rights to medical freedom and child rearing, they said in court papers.
Tongs office said only one part of the case remains active. It involves a single plaintiffs claim based on the Individuals with Disabilities Education Act (IDEA). While the office said it was confident the claim will be dismissed, Festa said federal law is clear that schools are required to provide a free and appropriate education for children with disabilities who have individual education plans, even if a child claims a religious exemption to vaccinations.
We The Patriots USA also has an ongoing federal lawsuit filed on behalf of a Christian preschool and daycare thats challenging Connecticuts vaccine mandate on constitutional grounds.
It is our practice at We The Patriots USA to battle on many fronts simultaneously, and to never put all of our eggs in one basket, Festa said, calling the Supreme Courts decision on Monday one setback, but far from a total defeat.
NEW YORK and MAINZ, Germany, June 27, 2024 Pfizer Inc. (NYSE: PFE, Pfizer) and BioNTech SE (Nasdaq: BNTX, BioNTech) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for the companies Omicron JN.1-adapted monovalent COVID-19 vaccine (COMIRNATY JN.1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The adaptation is based on the recommendation from the World Health Organization (WHO) Technical Advisory Group on COVID-19 Vaccine Composition and the European Medicines Agency's Emergency Task Force (ETF) to update COVID-19 vaccines to target the SARS-CoV-2 variant JN.1 for the 2024-2025 vaccination campaign. ETF stated that evidence indicates that targeting JN.1 will help maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve. 1, 2
The European Commission (EC) will review the CHMPs recommendation and is expected to make a final decision soon. Following the EC decision, the updated vaccine will be available to ship to applicable EU member states immediately. Pfizer and BioNTech have been manufacturing the Omicron JN.1-adapted monovalent COVID-19 vaccine at risk to ensure supply readiness ahead of the upcoming fall and winter season when the demand for COVID-19 vaccination is expected to increase.3
The CHMPs recommendation is based on the full body of previous clinical, non-clinical, and real-world evidence supporting the safety and efficacy of the COVID-19 vaccines by Pfizer and BioNTech. The application also included manufacturing and pre-clinical data showing that the JN.1-adapted monovalent COVID-19 vaccine generates a substantially improved response against multiple Omicron JN.1 sublineages, including KP.2, KP.3 and other currently circulating sublineages, compared with the companies Omicron XBB.1.5-adapted monovalent COVID-19 vaccine.4
Pfizer and BioNTech are starting rolling applications with the U.S. Food and Drug Administration (FDA), per recent FDA recommendation, requesting approval of their Omicron KP.2-adapted monovalent COVID-19 vaccines for individuals 6 months of age and older. The companies will continue to monitor the evolving epidemiology of COVID-19 and make appropriate preparations to meet global public health needs.
The COVID-19 vaccines (COMIRNATY) by Pfizer and BioNTech are based on BioNTechs proprietary mRNA technology and were developed by both companies. BioNTech is the Marketing Authorization Holder for COMIRNATY and its adapted vaccines (COMIRNATY Original/Omicron BA.4-5; COMIRNATY Omicron XBB.1.5) in the United States, the European Union, the United Kingdom, and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.
AUTHORIZED USE IN THE EU: COMIRNATY has been granted standard marketing authorization (MA) by the European Commission to prevent coronavirus disease 2019 (COVID-19) in people from the age of 6 months. The vaccine is administered as a single dose in people 5 years of age and older, and as a three-dose series, in infants and children from 6 months to 4 years who have not had COVID-19 with the first two doses are given three weeks apart, followed by a third dose given at least 8 weeks after the second dose. Adults and adolescents from the age of 12 are given 30 micrograms per dose; children aged 5 to 11 years are given 10 micrograms per dose; infants and children aged 6 months to 4 years are given 3 micrograms per dose. Additional doses may be administered to individuals aged 5 years and older who are severely immunocompromised in accordance with national recommendations. The European Medicines Agencys (EMAs) Committee for Medicinal Products for Human Use (CHMP) has completed its rigorous evaluation of COMIRNATY, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are available.
In addition, COMIRNATY has also been granted standard MA for two adapted vaccines: COMIRNATY Original/Omicron BA.4-5, which contains mRNA encoding for the spike protein of the wild-type and of the Omicron BA.4/BA.5 subvariant of SARS-CoV-2; and COMIRNATY Omicron XBB.1.5, which contains mRNA encoding for the spike protein of the Omicron XBB.1.5 subvariant of SARS-CoV-2.
COMIRNATY Omicron XBB.1.5 may be administered as a single dose regardless of prior vaccination status in people aged 5 years and older. Children from 6 months to 4 years of age may have one or three doses depending on whether they have completed a primary vaccination course or have had COVID-19. There should be an interval of at least 3 months between administration of COMIRNATY Original/Omicron BA.4-5 or COMIRNATY Omicron XBB.1.5 and the last prior dose of a COVID-19 vaccine.
IMPORTANT SAFETY INFORMATION
The black equilateral triangle denotes that additional monitoring is required to capture any adverse reactions. This will allow quick identification of new safety information. Individuals can help by reporting any side effects they may get. Side effects can be reported to EudraVigilance or directly to BioNTech using email medinfo@biontech.de, telephone +49 6131 9084 0, or via the website www.biontech.de
About Pfizer: Breakthroughs That Change Patients Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website atwww.Pfizer.com. In addition, to learn more, please visit us onwww.Pfizer.comand follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook atFacebook.com/Pfizer.
Pfizer Disclosure Notice The information contained in this release is as of June 27, 2024. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about Pfizers efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162b2 mRNA vaccine program, and the Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) including an Omicron-adapted monovalent COVID-19 vaccine candidate, based on the JN.1 lineage, including a submission to the European Medicines Agency (EMA) for an Omicron-adapted monovalent COVID-19 vaccine, based on the JN.1 lineage, expectations regarding the demand for COVID-19 vaccines, planned regulatory submissions, qualitative assessments of available data, potential benefits, expectations for clinical trials, potential regulatory submissions, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including Phase 1/2/3 or Phase 4 data), including the data discussed in this release for BNT162b2, any monovalent or bivalent vaccine candidates or any other vaccine candidate in the BNT162 program in any of our studies in pediatrics, adolescents, or adults or real world evidence, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies, in real world data studies or in larger, more diverse populations following commercialization; the ability of BNT162b2, any monovalent or bivalent vaccine candidates or any future vaccine to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when submissions to request emergency use or conditional marketing authorizations for BNT162b2 in additional populations, for a potential booster dose for BNT162b2, any monovalent or bivalent vaccine candidates or any potential future vaccines (including potential future annual boosters or re-vaccination), and/or other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2, any monovalent or bivalent vaccine candidates or any other potential vaccines that may arise from the BNT162 program, including a potential variant-based, higher dose, or bivalent vaccine, and if obtained, whether or when such emergency use authorizations or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including any requested amendments to the emergency use or conditional marketing authorizations), any monovalent or bivalent vaccine candidates (including the submission to the EMA for an Omicron-adapted monovalent COVID-19 vaccine candidate, based on the JN.1 lineage), or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccines benefits outweigh its known risks and determination of the vaccines efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist or not meet expectations which may lead to reduced revenues or excess inventory on-hand and/or in the channel which, for our COVID-19 vaccine, resulted in significant inventory write-offs in 2023 and could continue to result in inventory write-offs, or other unanticipated charges; challenges related to the transition to the commercial market for our COVID-19 vaccine; uncertainties related to the publics adherence to vaccines, boosters, treatments or combinations; risks related to our ability to accurately predict or achieve our revenue forecasts for our COVID-19 vaccine or any potential future COVID-19 vaccines; potential third-party royalties or other claims related to our COVID-19 vaccine; the risk that other companies may produce superior or competitive products; risks related to the availability of raw materials to manufacture or test a vaccine; challenges related to our vaccines formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant-based vaccines; the risk that we may not be able to maintain or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; uncertainties regarding the impact of COVID-19 on Pfizers business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizers Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available atwww.sec.govandwww.pfizer.com.
About BioNTech Biopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor (CAR) T cells, several protein-based therapeutics, including bispecific immune checkpoint modulators, targeted cancer antibodies and antibody-drug conjugate (ADC) therapeutics, as well as small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global and specialized pharmaceutical collaborators, including Biotheus, DualityBio, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron.
For more information, please visitwww.BioNTech.com.
BioNTech Forward-looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not be limited to, statements concerning: BioNTechs efforts to combat COVID-19; the collaboration between BioNTech and Pfizer; the rate and degree of market acceptance of BioNTechs COVID-19 vaccine, including the Omicron JN.1-adapted adapted monovalent COVID-19 vaccine; qualitative assessments of available data and expectations of potential benefits, including the adapted vaccines response against multiple Omicron JN.1 sublineages, including KP.2, KP.3 and other currently circulating sublineages; regulatory submissions and regulatory approvals or authorizations and expectations regarding manufacturing, distribution and supply; expectations regarding anticipated changes in COVID-19 vaccine demand, including changes to the ordering environment; and expected regulatory recommendations to adapt vaccines to address new variants or sublineages. In some cases, forward-looking statements can be identified by terminology such as will, may, should, expects, intends, plans, aims, anticipates, believes, estimates, predicts, potential, continue, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTechs control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the data discussed in this release, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; BioNTechs pricing and coverage negotiations with governmental authorities, private health insurers and other third-party payors after BioNTechs initial sales to national governments; the future commercial demand and medical need for initial or booster doses of a COVID-19 vaccine; the availability of raw materials to manufacture a vaccine; our vaccines formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery; competition from other COVID-19 vaccines or related to BioNTechs other product candidates, including those with different mechanisms of action and different manufacturing and distribution constraints, on the basis of, among other things, efficacy, cost, convenience of storage and distribution, breadth of approved use, side-effect profile and durability of immune response; the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; the timing of and BioNTechs ability to obtain and maintain regulatory approval for BioNTechs product candidates; the ability of BioNTechs COVID-19 vaccines to prevent COVID-19 caused by emerging virus variants; BioNTechs and its counterparties ability to manage and source necessary energy resources; BioNTechs ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTechs third-party collaborators to continue research and development activities relating to BioNTechs development candidates and investigational medicines; the impact of the COVID-19 pandemic on BioNTechs development programs, supply chain, collaborators and financial performance; unforeseen safety issues and potential claims that are alleged to arise from the use of BioNTechs COVID-19 vaccine and other products and product candidates developed or manufactured by BioNTech; BioNTechs and its collaborators ability to commercialize and market BioNTechs COVID-19 vaccine and, if approved, its product candidates; BioNTechs ability to manage its development and expansion; regulatory developments in the United States and other countries; BioNTechs ability to effectively scale BioNTechs production capabilities and manufacture BioNTechs products, including BioNTechs target COVID-19 vaccine production levels, and BioNTechs product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time.
You should review the risks and uncertainties described under the heading Risk Factors in BioNTech's Report on Form 6-K for the period ended March 31, 2024, and in subsequent filings made by BioNTech with the SEC, which are available on the SECs website at www.sec.gov. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise.
CONTACT
Pfizer: Media Relations +1 (212) 733-1226 PfizerMediaRelations@pfizer.com
Investor Relations +1 (212) 733-4848 IR@pfizer.com
BioNTech: Media Relations Jasmina Alatovic +49 (0)6131 9084 1513 Media@biontech.de
Investor Relations Victoria Meissner, M.D. +1 617 528 8293 Investors@biontech.de
---------- 1 World Health Organization (WHO) Statement on the antigen composition of COVID-19 vaccines. 26 April 2024. Available at: https://www.who.int/news/item/26-04-2024-statement-on-the-antigen-composition-of-covid-19-vaccines#:~:text=In%20May%202023%2C%20the%20TAG,1.5%2C%20as%20the%20vaccine%20antigen (Accessed 26.06.2024).
2 European Medicines Agency (EMA) ETF recommends updating COVID-19 vaccines to target new JN.1 variant. 30 April 2024. Available at: https://www.ema.europa.eu/en/news/etf-recommends-updating-covid-19-vaccines-target-new-jn1-variant (Accessed 26.06.2024).
3 European Medicines Agency (EMA) ETF recommends updating COVID-19 vaccines to target new JN.1 variant. 30 April 2024. Available at: https://www.ema.europa.eu/en/news/etf-recommends-updating-covid-19-vaccines-target-new-jn1-variant (Accessed 26.06.2024).
4 Vaccines and Related Biological Products Advisory Committee June 5, 2024 Meeting Presentation- Pfizer/BioNTech Clinical and Preclinical Supportive Data 2024-2025 COVID19 Vaccine Formula. https://www.fda.gov/media/179144/download (Accessed 26.06.2024).
The Centers for Disease Control and Prevention issued recommendations on Thursday that nearly all Americans over 6 months old get an updated COVID-19 and flu shot this fall.
The CDC said that as soon as updated COVID-19 shots from Moderna, Novavax and Pfizer are available later this year, the public should get an updated vaccine, regardless of past vaccination status.
Earlier this month, the Food and Drug Administration provided updated guidance for COVID-19 vaccine makers, calling for them to formulate a shot that better targets more recent strains of the virus. The FDA said that fall 2024 COVID-19 vaccines should target the KP.2 variant of the virus, which is a descendant of the JN.1 variant that widely circulated throughout the U.S. during the winter.
Related story: COVID cases on the rise in 39 states, marking the start of an anticipated summer surge
Additionally, the CDC said that updated flu shots should be sought in September or October for most people. Pregnant people who are in their third trimester and children who need two doses of the flu vaccine could get a flu vaccine sooner. The CDC also said some people who are unable to get vaccinated in September or October should consider getting an updated flu vaccine as soon as it becomes available.
Our top recommendation for protecting yourself and your loved ones from respiratory illness is to get vaccinated, said Dr. Mandy Cohen, director of the CDC. Make a plan now for you and your family to get both updated flu and COVID vaccines this fall, ahead of the respiratory virus season.
Pfizer and BioNTech have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Comirnaty JN.1, an Omicron JN.1-adapted monovalent Covid-19 vaccine.
The CHMP has recommended marketing authorisation for Comirnaty JN.1 for active immunisation against Covid-19 caused by SARS-CoV-2 in individuals aged six months and above.
The adaptation of the positive opinion by CHMP has been driven by recommendation from the World Health Organization (WHO) Technical Advisory Group on Covid-19 Vaccine Composition and the European Medicines Agencys Emergency Task Force (ETF).
Both organisations recommended revising Covid-19 vaccines for the 2024-2025 vaccination campaign, focusing on targeting the SARS-CoV-2 variant JN.1.
ETF said that evidence shows that targeting the JN.1 variant will help sustain the vaccines effectiveness as SARS-CoV-2 continues to evolve.
The CHMPs recommendation is based on the full body of previous clinical, non-clinical, and real-world evidence that back the safety and efficacy of Pfizer and BioNTechs Covid-19 vaccines.
The application also included manufacturing and pre-clinical data demonstrating that the JN.1-adapted monovalent Covid-19 vaccine elicits a significantly enhanced immune response.
The vaccine showed superior results against various Omicron JN.1 sublineages, such as KP.2, KP.3, and other currently circulating sublineages, in comparison to the companies Omicron XBB.1.5-adapted monovalent Covid-19 vaccine.
The European Commission (EC) will assess the CHMPs recommendation and is anticipated to reach a final decision shortly.
Once approved by the EC, the updated vaccine is expected to be promptly shipped to eligible European Union (EU) member states.
Pfizer and BioNTech are said to have proactively manufactured the Omicron JN.1-adapted monovalent Covid-19 vaccine at risk to ensure readiness for the upcoming season.
Both companies are commencing rolling applications to the US Food and Drug Administration (FDA) for vaccine approval.
Comirnaty utilise BioNTechs proprietary mRNA technology which was jointly developed by the companies.
BioNTech holds the marketing authorisation for the vaccine and its adapted versions like Comirnaty Original/Omicron BA.4/5; and Comirnaty Omicron XBB.1.5 in the US, the EU, the UK, and other countries.
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