Category: Covid-19 Vaccine

By Tanya Terry, with featured photo of Dr. Chijioke Bennett provided by SVP Healthcare

This month,CDC projected that the variant JN.1 comprises an estimated 1529% of in the United States as of December 8, 2023.It is currently the fastest-growing variant in the United States.

Novavax continues to monitor the changing nature of the virus and is conducting ongoing testing of our vaccine as new mutations and variants evolve, said Chijioke Bennett, MD, MPH, MBA, senior director, Clinical Development at Novavax.

Bennett added: The JN.1 is closely related to a strain we have seen before (BA.2.86). It has evolved to have better transmissibility or somehow better escape immunity; however, thankfully it doesnt seem to be causing severe disease. These attributes of the JN.1 variant necessitate the need for updated vaccinations, especially now.

According to Bennett, preclinical data in animals has shown that when given Novavaxs updated XBB.1.5 vaccine (which is what we have available presently in the U.S.) following completion of the earlier primary series with a prototype/BA.5 vaccine, Novavaxs updated protein-based COVID-19 vaccine induces broadly neutralizing responses against strains not contained in the vaccine including BA.2.86.

I encourage people to recognize the importance of making a plan to help protect their loved ones this season and to have conversations with their healthcare provider about available vaccine options. Bennett said.

On Thursday, December 14, theCDC issued a health advisorywarning that low vaccination rates for COVID coupled with ongoing increases in respiratory disease activity (COVID, flu and RSV)could lead to more severe disease and increased healthcare capacity strain in the coming weeks.

It is very concerning. COVID-19-related hospitalizations have continued to rise in the U.S., according to the CDC. Experts have reiterated that, despite COVID-19 fatigue, our best line of defense to protect communities is to get vaccinated with the latest vaccines.Without vaccination, COVID-19 cases and hospitalization rates may continue to rise, posing significant risks for vulnerable populations such as the elderly, immunocompromised and people with preexisting conditions that put them at risk.

There has been a rise in COVID related hospitalizations as of early December within the U.S. as a whole, as well as in Genesee County as of early December

The latest data from the CDC shows that as of Dec. 9,18.2% of American adultshave received an updated COVID-19 vaccine. In Michigan, theadult vaccination rate hovers at 18%. Additionally, according to the latest CDC estimates, only 13.9% ofnon-Hispanic Black adultshave received an updated COVID-19 vaccine.

Bennett stressed the best line of defense is to get vaccinated with the latest vaccines.

Its critical that we educate communities about the different vaccine options available so that they can make the choice thats best for themselves and their loved ones.

Without vaccination, these rates may continue to rise, posing significant risks for vulnerable populations such as the elderly, immunocompromised and people with pre-existing conditions such as diabetes, COPD, and obesity that put them at higher risk of severe disease.

Without vaccination, these rates may continue to rise, posing significant risks for vulnerable populations such as the elderly, immunocompromised and people with pre-existing conditions such as diabetes, COPD, and obesity that put them at higher risk of severe disease.

With cold weather and more time spent indoors in close proximity to others, the risk of respiratory virus infection increases. Bennett said this is also true of both flu and COVID-19.

The holiday season upon us and more time spent indoors in close proximity to others, the risk of respiratory virus infection increases. However, vaccination rates for COVID-19 during the 2023 immunization seasons have been lower than expected.

The most important thing is to include vaccination in your plan before family gatherings, and to monitor yourself if you are experiencing any COVID-19 or flu symptoms. This immunization season, people have options for vaccination, including a non-mRNA protein-based vaccine. Developed by Novavax, using a well-established technology also used to develop other common vaccines, Novavaxs updated COVID vaccine provides an important option, allowing Americans to decide how best to protect themselves and their families, in consultation with their healthcare provider.

Bennett pointed out that for those who are unvaccinated, elderly or immunocompromised, virtual gatherings are always a good option.

Families and friends need to make the choice thats best for them, in consultation with a healthcare provider

Non-clinical data previously showed that Novavaxs updated COVID-19 vaccine induced functional immune responses for XBB.1.5, XBB.1.16 and XBB.2.3 variants, indicating a broad response that could potentially be applicable for forward-drift variants.

On October 3, 2023, the Food and Drug Administration amended the emergency use authorization (EUA) of Novavax COVID-19 Vaccine, Adjuvanted to include the 2023-2024 formula.

The updated protein-based monovalent formulation includes the XBB.1.5 sublineage of SARS-CoV-2. Additionally, saponin-based Matrix-M adjuvant technology enhances and prolong immune responses.

In the U.S., the Novavax vaccine is the only non-mRNA protein-based updated COVID-19 vaccine available, developed in line with guidance issued by the FDA.

In Flint, the updated Novavax COVID vaccine is available at Rite Aid and CVS pharmacies. Appointments are not needed.

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Updated COVID-19 vaccine helps protect families from JN.1 over holidays The Courier News - Flint Courier News

In January 2024, Huron Perth Public Health (HPPH) will shift its COVID-19 vaccine program and specifically focus on providing COVID-19 vaccinations for youth aged 11 and under at their clinics.

Weve been proud to work with pharmacists and local healthcare providers this fall to ensure residents of Huron-Perth had access to COVID-19 vaccinations, says Dr. Miriam Klassen, Medical Officer of Health for Huron Perth. While pharmacists and participating healthcare providers will continue to provide COVID-19 XBB vaccinations in the community, HPPH will focus on ensuring access to youth aged 11 and under.

Children are a priority population that may also require a series of vaccine doses to be protected, notes a spokesperson from HPPH, In addition, access to pediatric vaccination may be more limited (e.g., less access through pharmacies because they may not vaccinate children under age 5). Thus, the health unit needs to maintain this service throughout the respiratory season to ensure that children are able to access and complete their vaccine series.

The response to COVID-19 has begun to be incorporated into regular public health work, including the discontinuation of one-time COVID funding from the provincial government. Because of this, the health unit says they will not have the capacity to continue to offer as many COVID-19 vaccine clinics in 2024 as years past.

This fall in Ontario, 75 percent of COVID-19 vaccine administration has happened through pharmacies, said an HPPH spokesperson, Vaccines will continue to be available through participating pharmacies and primary care providers. Improving access is one effective strategy to increase vaccine uptake; where there are barriers, vaccination rates may be lower.

HPPH is urging community members to get vaccinated for COVID-19, and according to the HPPH Respiratory Activity 2023-2024 dashboard, there were 51 cases of COVID-19 reported and four cases of influenza reported in the last week of November. In addition, there were 12 hospitalizations due to COVID-19 and one hospitalization due to flu. Sadly, since the start of the respiratory season, seven residents of Huron and Perth have died due to COVID-19.

Story continues

The holiday season has begun, says Dr. Klassen. Please protect yourselves and your loved ones by getting vaccinated against influenza, COVID-19 and RSV, if eligible. Note that at this time in Ontario, only residents of long-term care homes and some retirement homes are eligible for RSV vaccine. Its not too late to get your vaccines to protect your families and communities and enjoy a safe and happy holiday season.

Residents can reduce their risk and their loved ones risk by staying up to date on vaccines and using other means of protection:

1. Wearing a tight-fitted, well-constructed mask in indoor public settings for anyone at the highest risk of severe infection and when in healthcare settings/places with mask policies.

2. Staying home when you are sick and wearing a mask until day ten from symptom onset

3. Washing hands often

4. Covering your mouth when you cough or sneeze

5. Regularly cleaning high-touch surfaces

6. Optimizing indoor air quality

7. If you are at high risk, speak with your healthcare provider about antiviral treatment options.

Amanda Modaragamage, Local Journalism Initiative Reporter, Stratford Times

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Changes to COVID-19 vaccine administration at Huron Perth Public Health - Yahoo News Canada

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Posted: December 20, 2023 Last Updated: December 20, 2023

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Canadians raced to get vaccinated against COVID-19 in the first years of the pandemic, but data suggests there's far less of a rush to get the latest shots available this fall.

Federal figures show only 15 per cent of the population aged five and up had received an updated vaccine by Dec. 3.And while older age groups had higher uptake rates, more than half of higher-risk older adults still hadn't gotten a dose by early December, either.

The shots, tailored to the XBB.1.5 Omicron subvariant, are meant to shore up protection against the SARS-CoV-2 descendants currently circulating.

Medical experts say seniors and other higher-risk individuals could leave themselves more vulnerable to serious illness if they skip these updated shots. Less than a third of Canadians in their 60s have had the newest vaccine, along with roughly 44 per cent of people in their 70s, and 48 per cent of those aged 80 and older.

Pandemic fatigue, muddled messagingand complex vaccination timelines might be dissuading Canadians from getting another round of vaccines, experts note.

"Why that gap exists is both an interesting and difficult question," said Dr. Allison McGeer, an infectious diseases specialist with Sinai Health in Toronto. "I think it's because people just aren't getting the message about how much of a risk COVID is."

Data shows SARS-CoV-2 is still circulating at high levels across much of Canada, sending hundreds of people into hospital with COVID every week. Weekly rates of hospitalizations and intensive care admissions remain highest among the oldest age groups.

The immune systems of various higher-risk groups including seniors, pregnant womenand people with other serious health issues can be weaker than those of most healthy adults, increasing their risk of serious illness of any kind.

At the same time, a growing body of evidence suggests that immunity against this ever-evolving virus fades over time, leaving people susceptible to repeat infections.

Just this week, the World Health Organization (WHO) announced yet another variant of interestknown as JN.1, an Omicron offshoot that's rapidly spreading around the world. (WHO officials said the latest batch of vaccines are expected to maintain protection against serious illness and death from this variant as well.)

That's why updated shots can make a difference, according to Canada's chief public health officer, Dr. Theresa Tam.

Tam told CBC News there's "room for improvement" when it comes to vaccine uptake among older Canadians. "That's the group, of course, that has the highest risk of severe outcomes," she added.

Close to a third of the country's older population doesn't appear to have been infected with this virus yet either, Tam noted.

"They've been protecting themselves. They've been getting vaccinated," she added. "But the vaccine base protection can wane over time even protection against severe outcomes wanes over time."

That message doesn't seem to be reaching the public, warnedMcMasterUniversity immunologist and researcher Dawn Bowdish.

Many Canadians think there's a "magic number" of vaccinedoses that will protect them long-term from COVID, but that's incorrect, Bowdish said.

While the overall risks of SARS-CoV-2 infections may be lower now than during the early days of the pandemic, fresh shots are necessary while this virus is still "rapidly adapting."

COVID shots don't act like many of our childhood vaccines, she explained, since this type of virus operates in a specific way: Much like older coronaviruses known for causing the common cold, SARS-CoV-2 has a "remarkable capacity to cause repeat infections" by evolving to better dodge the frontline defences of the human immune system.

That means vulnerable individuals should treat the latest COVID vaccines like annual flu shots not boosters to ensure their immune system is primed to tackle new variants and avoid serious illness and lingering, life-altering health impacts, she said.

"We know that having COVID increases risks of heart attacks and other complications, especially in older adults," Bowdish added.

"And importantly, if an older adult is hospitalized, it is very rare for them to leave the hospital and have the same level of function as they did before they went in."

WATCH | What seniors need to know about this year's fall vaccines:

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While the vaccine guidance for higher-risk groups is fairly straightforward, McGeer, in Toronto, said younger adults in their 20s and 30s may have more to consider as they weigh the risks and benefits.

The mRNA-based vaccines from Pfizer and Moderna have been linked to higher reactogenicity referring to expected post-vaccination reactions caused by someone's immune response, such as a fever or a sore arm which can discourage some people from getting another shot, McGeer said.

Novavax's protein-based, non-mRNA vaccine is now approved as well, and doses have been delivered to the Public Health Agency of Canada for distribution to the provinces, but McGeer said it likely won't be as widely available, making it harder to access for many Canadians who want a more traditional option.

People are also trying to navigate complex vaccination advice on how to time their next shots, she added. Guidance suggests waiting six months or so after your last vaccination or infection before getting another dose, which can complicate efforts to roll out seasonal immunization campaigns, since Canadians are operating on various schedules based on when they were last exposed to the virus.

Then there's the simple fact that so many people are tired of getting shot after shot, four years into the COVID pandemic.

"I think everyone has a little bit of COVID fatigue, including our policymakers," said Bowdish. "And so we haven't been as aggressive."

The medical experts who spoke to CBC News also didn't paint a clear picture of what the future could hold for COVID vaccination efforts.

Tam said the door is still open for another spring vaccination push, though she noted uptake last spring was also relatively low. Bowdish, the immunologist, agreed twice-annual vaccines may be appropriate given how quickly this virus is evolving.

McGeer, however, said over the long term, as more people gain repeat exposure to this virus earlier and earlier in life, the need for COVID vaccines could start to shift. A twice-annual vaccine seems unlikely, "and I'm not sure that we're even settling into an annual vaccine," she said.

But the world won't know for years, perhaps even decades, how this virus will evolve, what seasonal patterns it could settle into, and how those factors might change the risks of acute illness or lasting health impacts.

"How long that trajectory is going to take, and where it's going to stop, [is an] open question," McGeer said.

Lauren Pelley Senior Health & Medical Reporter

Lauren Pelley covers health and medical science for CBC News, including the global spread of infectious diseases, Canadian health policy, pandemic preparedness, and the crucial intersection between human health and climate change. Two-time RNAO Media Award winner for in-depth health reporting in 2020 and 2022. Contact her at: lauren.pelley@cbc.ca

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Just 15% of Canadians got updated COVID vaccines this fall, new figures show - CBC.ca

Jakarta / Tue, December 26, 2023 / 07:48 am

Vials containing the Inavac vaccine for COVID-19 are seen on Dec. 19, 2023, at the Jakarta Health Agency office during a vaccination campaign held to administer a fifth precautionary vaccine dose amid concerns that COVID-19 cases could spike during the Christmas and New Year's holidays.(AFP/Bay Ismoyo)

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Solidarity clouds loom over global health threats as 2023 ends - The Jakarta Post - The Jakarta Post

In a recent study published in the journal Scientific Reports, researchers examined the effects of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination on insomnia, depression, and anxiety.

The coronavirus disease 2019 (COVID-19) pandemic has unprecedentedly impacted society. Evidence suggests increased rates of psychiatric disorders during the pandemic. Further, studies have observed a reduced prevalence of anxiety and depressive symptoms among people vaccinated for COVID-19 compared to non-vaccinated individuals in the United States (US).

Likewise, another study revealed that the prevalence of these symptoms declined after vaccination in Bangladesh. Although over 3.5 billion vaccine doses have been administered in China until April 2023, data on the effects of vaccination on mental health outcomes are limited.

Study: SARS-CoV-2 vaccination may improve anxious, insomnia and depressive symptoms among Chinese population aged 1875 years during the COVID-19 pandemic. Image Credit:aslysun/ Shutterstock

The present study investigated whether COVID-19 vaccination could mitigate insomnia, anxiety, and depressive symptoms during the pandemic. Chinese adults aged 1875 who could complete online questionnaires were recruited. Individuals with psychiatric diseases or incomplete data were excluded.

The team developed a standard questionnaire for demographics and socioeconomic indicators. The seven-item generalized anxiety disorder (GAD-7) assessment was used to examine anxiety symptoms. GAD-7 scores 14, 59, 1014, and 1521 indicated minimal, mild, moderate, and severe symptoms, respectively.

A GAD-7 score 5 was deemed the critical value for anxiety. The Athens Insomnia Scale (AIS)-8 was used to assess symptoms of insomnia. AIS-8 scores ranged between 0 and 24. The AIS-8 score of six points was deemed critical for diagnosing insomnia with clinical significance. The patient health questionnaire (PHQ-9) was used to evaluate depressive symptoms.

PHQ-9 scores ranged between 0 and 27, with higher scores indicating more severe depression. A PHQ-9 score 5 indicated clinical depressive disorder. The researchers used the hierarchical regression method to examine the effects of vaccination on insomnia, depression, and anxiety symptoms.

Flowchart of the sample selection.

In total, 9,452 individuals, aged 35.97 on average, were included. Of these, 76.2% were vaccinated, while the remainder were non-vaccinated. Over 71% of participants were urban residents, 68.5% were married, and 85% had a monthly income 10,000 RMB. Overall, 17.7% of respondents had symptoms of anxiety, 22.7% had symptoms of insomnia, and 28.4% showed depressive symptoms.

The median PHQ-9, GAD-7, and AIS-8 scores of non-vaccinated individuals were 6, 3, and 4 points, respectively, and were considerably higher than for vaccinated individuals. The COVID-19 vaccination significantly decreased the prevalence of severe symptoms of anxiety or depression. Anxiety prevalence (9.7%) in the vaccinated group was substantially lower than in the non-vaccinated group (43.7%).

Moreover, individuals with anxiety were younger than those without. Likewise, the prevalence of insomnia was lower in the vaccinated group (16.2%) compared to non-vaccinated individuals (43.7%). Further, insomnia prevalence in people with anxiety was 63.3% compared to 4.3% among those without anxiety. Besides, depressive symptoms were less prevalent among vaccinated individuals (19.7%) than in the non-vaccinated group (56.1%).

The prevalence of depressive symptoms was significantly higher among individuals with insomnia (81.7%) or anxiety (93.4%) compared to those without insomnia or anxiety. The researchers noted a significant association between the COVID-19 vaccination and anxiety symptoms. That is, the vaccinated group had about 85% lower anxiety risk than the non-vaccinated group, adjusted for potential confounders (age, sex, marital status, income, education, and occupation).

Further, vaccinated individuals had a 74.9% lower risk of insomnia than non-vaccinated participants, adjusted for confounders. When additionally adjusted for anxiety symptoms, the vaccinated group had 40% lower odds of insomnia compared to the non-vaccinated group. Besides, vaccinated participants also had about 80% lower risk of depression than non-vaccinated subjectsthis association was sustained after additionally adjusting for anxiety or insomnia.

To summarize, the researchers investigated whether COVID-19 vaccination has a positive impact on symptoms of depression, anxiety, and insomnia during the pandemic. Vaccinated individuals showed significantly lower scores on the PHQ-9, AIS-8, and GAD-7 scales than non-vaccinated individuals. Moreover, vaccination was associated with a reduced risk of depressive, anxiety, and insomnia symptoms.

The studys limitations include its non-generalizability to other populations, including minors and elderly individuals. Moreover, the self-reported nature of the study may have introduced some level of (reporting) bias. Besides, the significant difference in size between the vaccinated and non-vaccinated groups might reduce statistical power. Taken together, the findings illustrate that the COVID-19 vaccination may help alleviate anxiety, insomnia, and depression.

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COVID-19 vaccination eased anxiety, insomnia, and depression in Chinese adults, study finds - News-Medical.Net

A study of hospitalized Veterans Affairs (VA) patients found that combination therapy was not associated with decreased mortality for multidrug-resistant (MDR) Acinetobacter infections, researchers reported yesterday in Antimicrobial Stewardship & Healthcare Epidemiology.

The retrospective cohort study, led by a team of VA researchers, looked at VA patients who were hospitalized with MDR Acinetobacter bacteremia and received antibiotics 2 days prior through 5 days after the culture date from 2012 through 2018. The aim was to assess the impact of antibiotic treatments on in-hospital, 30-day, and 1-year mortality and costs.

MDRAcinetobacter spp.was identified in 184 patients. Most patients were older (mean age, 67 years), White, non-Hispanic men. The vast majority of cultures identified wereA baumannii (90%), while 3% wereA lwoffii,and 7% were otherAcinetobacter species.Half (50.5%) of the infected patients died in hospital, 44% within 30 days, and 67.9% within 1 year.

Penicillins/beta-lactamase inhibitor combinations (51.1%) and carbapenems (51.6%) were the most prescribed antibiotics. In unadjusted analysis, extended-spectrum cephalosporins and penicillins/beta-lactamase inhibitor combinations were associated with a decreased odds of 30-day mortality, but the effect was insignificant after adjustment (adjusted odds ratio (aOR), 0.47; 95% confidence interval [CI], 0.21 to 1.05 and aOR, 0.75; 95% CI, 0.37 to 1.53, respectively). There was no association between combination therapy vs monotherapy and 30-day mortality (aOR, 1.55; 95% CI, 0.72 to 3.32).

The results are noteworthy, the authors say, because while the Sanford Guide and the Infectious Diseases Society of America recommend combination therapy (high-dose ampicillin-sulbactam plus an additional agent) for treating severe MDRAcinetobacterinfections, the findings add to evidence from prior studies that have found limited improved clinical outcomes with combination therapy.

"Our results provide additional comparative effectiveness demonstrating a lack of benefit to combination therapy given within 2 through +5 days from the culture date," they wrote.

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Study: 4% of US collegiate athletes developed long COVID - University of Minnesota Twin Cities

Geneva (Precision Vaccinations News)

The WHO Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) today announced that given the current SARS-CoV-2 coronavirus evolution and the breadth in immune responses demonstrated by monovalent XBB.1.5 vaccines against circulating variants, the TAG-CO-VAC advises retaining the current COVID-19 vaccine antigen composition (monovalent XBB.1.5) as the COVID-19 vaccine antigen.

Although neutralizing antibody titres have been shown to be important correlates of protection from SARS-CoV-2 infection and estimates of vaccine effectiveness (VE), there are multiple components of immune protection elicited by infection and/or vaccination.

Estimates of VE against currently circulating SARS-CoV-2 variants, including XBB descendent lineages, are limited in terms of the number of studies, geographic diversity, vaccine platforms evaluated, populations assessed, duration of follow-up and comparative estimates for monovalent XBB.1.5 vaccines versus other formulations.

As of December 13, 2023, data on the immune responses following XBB descendent lineage infection or XBB.1.5 vaccination are largely restricted to neutralizing antibodies, and data on other aspects of the immune response, including cellular immunity, are limitedin terms of the number of studies, vaccine platforms evaluated, populations assessed, duration of follow-up and comparative estimates for monovalent XBB.1.5 vaccines versus other formulations.

The World Health Organization says other vaccine formulations and/or platforms that achieve robust neutralizing antibody responses against currently circulating variants, including XBB- and BA.2.86 descendent lineages, can also be considered.

FollowingWHO SAGE policy, vaccination programs can continue to use any of the 12 WHO emergency-use listed or prequalified COVID-19 vaccines.

As previously stated, the TAG-CO-VAC continues to encourage the further development of vaccines that may improve protection against infection and reduce transmission of the SARS-CoV-2 virus.

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The WHO Continues Endorsing Monovalent XBB.1.5 COVID-19 Vaccines - Precision Vaccinations

FOR MEDICAL AUDIENCES ONLY

Novavaxs updated protein-based non-mRNA COVID-19 vaccine is now available for use in Germany for the prevention of COVID-19 in individuals aged 12 and older.

We are pleased that our vaccine is now available for healthcare providers to start vaccinating communities across Germany before the holidays. Freedom of choice for either non-mRNA or mRNA options as part of a diverse vaccine portfolio is critical to ensuring healthcare providers have options to help protect communities across Germany against COVID-19 this vaccination season and in future.

Non-clinical datashowed that Novavax's updated COVID-19 vaccine induced functional immune responses against XBB.1.5, XBB.1.16 and XBB.2.3 variants. Additional non-clinical data demonstrated that Novavax's vaccine induced neutralizing antibody responses to subvariants BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6 as well as CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. These data indicate Novavax's vaccine can stimulate both arms of the immune system and may induce a broad response against currently circulating variants.1,2

Forward-Looking Statements

Statements herein relating to the future of Novavax, its operating plans and prospects, including the availability of its updated XBB version of its Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) in Germany and the timing of delivery and distribution of its vaccine are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, manufacturing, distribution or export delays or challenges; Novavax's exclusive dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling and the impact of any delays or disruptions in their operations on the delivery of customer orders; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2022 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at http://www.sec.gov and http://www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

References:

Markov PV, Ghafari M, Beer M, et al. The evolution of SARS-CoV-2. Nat Rev Microbiol. 2023;21(6):361-379. doi:1

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Novavax's Updated COVID-19 Vaccine Now Available in Germany - Dec 11, 2023 - Novavax Investor Relations

Pfizers forecast for sales of its COVID-19 vaccine and treatment next year falls more than $5 billion short of the Wall Street consensus

By

TOM MURPHY AP Health Writer

December 13, 2023, 7:52 AM ET

3 min read

Pfizer heads into 2024 with a lower-than-expected sales forecast for its COVID-19 vaccine and treatment after weaker demand had already forced it to trim 2023 projections.

The drugmaker announced on Wednesday initial expectations for the new year that include about $8 billion in combined sales from its Comirnaty vaccine and the treatment Paxlovid. That falls more than $5 billion short of estimates on Wall Street.

The companys forecast for overall earnings and revenue next year also missed consensus. Pfizer shares continued their largely year-long slide in midday trading.

Pfizer leaders told analysts Wednesday that they expect vaccination and treatment rates to be about the same next year as they were in 2023. But they wanted to be conservative and offer a good floor for expectations to avoid creating any more uncertainty, CEO Albert Bourla said.

In mid-October, Pfizer said sales of both the vaccine and treatment were turning out weaker than expected. The company cut revenue projections for this year by $9 billion. Two weeks later, Pfizer said sales of the treatment and vaccine had slid 97% and 70%, respectively, in the third quarter.

Comirnaty and Paxlovid combined to rake in more than $56 billion in sales last year, easily making them Pfizer's two top-selling products.

But a down year for both was widely expected as demand slid and drugmakers switched to selling on the commercial market instead relying on the more stable payout of bulk government contracts.

Bourla also noted Wednesday in a call with analysts that the virus that triggered a global pandemic in 2020 is no longer top of mind, and that theres some COVID-19 fatigue and anti-vaccine rhetoric in the market.

Chief Financial Officer David Denton also called the virus unpredictable and said it was hard to model its performance. Even so, he said Pfizer expects both the market-leading treatment and vaccine to remain significant products.

They meet a very large and high unmet need of the patient population around the globe, he said.

The company said that it expects full-year revenue in 2024 of between $58.5 billion and $61.5 billion, short of the $62.7 billion that Wall Street was expecting, according to a survey of industry analysts by FactSet.

The New York drugmaker expects to post per-share earnings of between $2.05 and $2.25 next year. Wall Street was projecting earnings of around $3.17 per share.

Pfizer also said that it was expanding its cost-cutting program by $500 million. Company leaders noted that recently acquired cancer treatment developer Seagen will start contributing revenue in the new year.

The company said it had no plans to cut its quarterly dividend which now totals 41 cents per share.

Shares of Pfizer Inc. slid more than 8% to $26.12 in late-morning trading while broader indexes climbed.

The stock had already already shed more than 44% of its value so far this year.

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Switch from selling COVID-19 drugs on market rather than to governments continues to sting at Pfizer - ABC News

FOR MEDICAL AUDIENCES ONLY

Novavaxs updated protein-based non-mRNA COVID-19 vaccine is now available for use in Austria for the prevention of COVID-19 in individuals aged 12 and older.

Healthcare professionals may order the updated vaccine directly from the Bundesbeschaffung GmbH, Austrias Federal Procurement Agency. We believe a diverse vaccine portfolio with both non-mRNA and mRNA options is critical to helping to protect Austrian communities against COVID-19 and particularly important as we head into the holiday season.

Non-clinical datashowed that Novavax's updated COVID-19 vaccine induced functional immune responses against XBB.1.5, XBB.1.16 and XBB.2.3 variants. Additional non-clinical data demonstrated that Novavax's vaccine induced neutralizing antibody responses to subvariants BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6 as well as CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. These data indicate Novavax's vaccine can stimulate both arms of the immune system and may induce a broad response against currently circulating variants.1,2

Forward-Looking Statements

Statements herein relating to the future of Novavax, its operating plans and prospects, including the availability of its updated XBB version of its Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) in Austria and the timing of delivery and distribution of its vaccine are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; manufacturing, distribution or export delays or challenges; Novavax's exclusive dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling and the impact of any delays or disruptions in their operations on the delivery of customer orders; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2022 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at http://www.sec.gov and http://www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

References:

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Novavax's Updated COVID-19 Vaccine Now Available in Austria - Dec 11, 2023 - Novavax Investor Relations