Category: Corona Virus Vaccine

General description of participants

Of the 8,990 eligible participants included in the survey analysis, 3,788 (42.14%) were vaccinated in Shanghai, 2,258 (25.12%) were vaccinated in Fuzhou, and 2,944 (32.75%) were vaccinated in Chengdu (see Table 1). Participants mean age was 29.55 (SD=11.63), most were male (55.98%), unmarried (59.21%), non-disabled (98.87%), white-collars or students (67.91%) and had graduated from university or junior college (63.16%). Most (75.45%) reported a monthly household income of 20,000 or less. The sample was representative of general population in terms of gender and income.

Table 2 presents the distribution and the univariate analysis of the possible factors relevant in the vaccination process. Some of the factors associated with both consideration and accessibility phases were statistically significant; they were region, education, occupation, brand preference, vaccination hesitancy, and domestic risk awareness (p<0.05). Disability status (p=0.001) and GP (p<0.001) were associated only with the consideration phase, while household income (p=0.002) difference was observed in the accessibility phase.

The logistic regression models (Fig.1) included the following variables: region, SES (education, occupation, income), attitudes towards COVID-19 and vaccines (vaccine brand preference, vaccination hesitancy, risk awareness for the domestic epidemic), and other basic characteristics of participants (age, sex, disability, contacted with GPs). Above variables were tested and found to be significant in at least one phase. All two models were statistically significant (p<0.05).

Multivariate analysis of factors associated with the two phases of the vaccination process. Binary logistic regression models were used to predict factors influencing the length of time categories to make an appointment and the length of time categories to receive a vaccination. The * was representative for p<0.05. Only the independent variables of the three dimensions (region, SES and personal attitudes towards COVID-19/vaccines) which are emphatically discussed in the study were represented in this figure. Covariates like disability and contacted with GPs were not presented

In the consideration phase (Fig.1), the odds of an appointment decision taking longer than one month were 2.26 (95% CI: 1.90 to 2.68) times greater for participants in Fuzhou and 2.48 (95%CI: 2.17 to 2.83) times greater for participants in Chengdu than for participants in Shanghai. Moreover, such odds increased for participants with master and above degree compared with those who were illiterate or graduated from primary school (OR: 1.76, 95% CI: 1.07 to 2.88). Participants with higher monthly household incomes (reference category:<5000) were also more likely to consider longer than one month. Occupational disparity was also significant. Compared with farmers, other professions, except for medical staff, were less likely to make an appointment within a month of hearing about COVID-19 vaccinations. For instance, the odds of the consideration phase being longer than one month were 3.37 (95%CI: 1.69 to 6.75) times greater for those engaged only in housework and for the unemployed than for farmers. Compared with participants with specific brand preference, the odds of the consideration phase being longer than one month were 1.13 (95%CI: 1.02 to 1.26) times greater for those without brand preference. The results also indicated that the odds of the consideration phase lasting more than a month increased with vaccination hesitancy (high hesitancy, OR: 2.98, 95%CI:2.50 to 3.55; medium hesitancy, OR:2.64, 95%CI:2.372.94; reference category: low hesitancy).

In the accessibility phase (Fig.1), the odds of waiting longer than one week to receive a vaccination were 8.82 (95% CI: 7.28 to 10.68) times greater for participants in Fuzhou and 2.28 (95%CI: 1.98 to 2.63) times greater for those in Chengdu than for participants in Shanghai. Such odds decreased only for participants with master and above degree compared to those who were illiterate or graduated from primary school (OR: 0.46, 95% CI: 0.29 to 0.75). Compared with farmers, teachers (OR: 0.51, 95%CI: 0.32 to 0.80) and students (OR: 0.32, 95%CI: 0.21 to 0.48) were less likely to wait longer than one week. The significant influence of monthly household income ()was merely found in one category(>=5000 and<10,000, OR:0.86, 95%CI:0.76 to 0.98, reference category:<5000). Meanwhile, participants without a brand preference (OR: 0.86, 95%CI: 0.77 to 0.95) were less likely to wait longer than a week after making an appointment to receive a vaccination. Moreover, this likelihood increased with higher risk awareness of a domestic epidemic (medium risk awareness, OR: 1.24, 95%CI:1.12 to 1.37; reference category: low risk awareness).

The multiple subgroup factor analysis for the vaccination processes in Shanghai, Fuzhou, and Chengdu are shown in Fig.2. The multi-variate models included following variables: SES (education, occupation, income), attitudes towards COVID-19 and vaccines (vaccine brand preference, vaccination hesitancy, risk awareness for the domestic epidemic), and other basic characteristics of participants (age, sex, disability, contacted with GPs). In Chengdu, no vaccine brand preference extended the consideration phase (OR:1.13, 95%CI:1.05 to 1.22, reference category: specific brand preference) but shortened the accessibility phase (OR:0.84, 95%CI:0.78 to 0.92). In Shanghai, the participants with no brand preference also tended to wait shorter in accessibility phase (OR:0.91, 95%CI:0.85 to 0.97). Participants graduating from senior high school were found to get vaccinated earlier after the appointment than those with lowest level of education (OR:0.45, 95%CI:0.27 to 0.75) in Shanghai. Higher household income in Shanghai and Chengdu and higher vaccination hesitancy in all three cities were significantly associated with longer consideration phase. Occupational disparities were found mainly in Shanghai. For example, house-based and unemployed participants were 3.47 (95% CI: 1.60 to 7.54) times more likely to have a longer consideration period than farmers.

Subgroup analysis of three cities: Shanghai, Fuzhou, and Chengdu. All six models were statistically significant (p<0.05). The * was representative for p<0.05. Variables included were the same in models for all three cities, while only variables that have at least one category that was significant in one or both phases are shown in the figure. Insignificant variables were not presented in the figure

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Accelerate the process of getting vaccinated: factors associated with consideration of and accessibility to COVID-19 vaccination in metropolises of...

ByJonathan Eichberger

People with HIV have a higher rate of breakthrough COVID-19 infections after vaccination compared to people without HIV, according to findings from a study led by researchers at the Johns Hopkins Bloomberg School of Public Health.

In the study, the researchers analyzed anonymized health records among nearly 114,000 people fully vaccinated with either two doses of mRNA vaccines or one dose of the J&J viral vector vaccine as of June 30, 2021 through December 31, 2021. Comparing vaccine recipients with and without HIV, the researchers found that the chance of a positive SARS-CoV-2 test result or a COVID-19 diagnosis within nine months after full vaccination, though low, was 28% higher among people with HIV. The risk of breakthrough infection during the period examined was 3.8% for the non-HIV group and 4.4% for the HIV group.

The results are published in JAMA Network Open.

Keri Althoff

Associate professor, Bloomberg School of Public Health

"These findings should alert all people with HIV to their greater risk of COVID-19 breakthrough, and can inform official recommendations about COVID-19 vaccination for people with HIV," says study senior author Keri Althoff, associate professor in the Bloomberg School's Department of Epidemiology.

Public health officials have had concerns about potentially elevated COVID-19 risk among people with weakened immune systems, including those with HIV, since the start of the pandemic. The Centers for Disease Control and Prevention currently recommends that people who are "moderately or severely immunocompromised"a category that includes people with HIV who are untreated or have low immune cell countsreceive an extra dose of vaccine as part of their primary vaccination series, followed by a booster. Studies so far have generated relatively little data on vaccination outcomes for people with HIV.

For their study, Althoff and her colleagues pooled individual-level data from four health systems in the U.S., to create a study population named the Corona-Infectious-Virus Epidemiology Team, or CIVET, cohort. The CIVET cohort contains de-identified records from private health insurers, the Veterans Affairs health care system, and an academic-affiliated health system. Patients in the study population had been receiving care for various conditions prior to the COVID-19 pandemic. The researchers examined the records of 113,994 people who had been fully vaccinated by June 30, 2021. Matching the 33,029 HIV-positive patients in the sample with the 80,965 HIV-negative patients (on age, race, sex, and date fully vaccinated), they compared the two groups' rates of SARS-CoV-2 breakthrough infections during the first nine months post-vaccination, or up to December 31, 2021, whichever came first.

The rates of breakthrough3.8% for the non-HIV group and 4.4% for the HIV groupare much lower than the rate of COVID-19 in unvaccinated people, suggesting a strong protective effect of vaccination. However, the analysis indicated the overall risk of breakthrough infection was 28% higher for the HIV group compared to the non-HIV group, after adjusting for differences between the groups.

Moreover, the study found an increasing risk of breakthrough with increasing immune suppression, measured via decreasing CD4 T-cell counts. Those with CD4 counts that signal moderate immune suppression in people with HIV had a statistically significant increase in the risk of breakthrough compared to people without HIV. That suggests, Althoff says, that people with HIV and moderate immune suppression may need to be included in the CDC's guidelines for additional doses of vaccine in the primary vaccination series.

"Policymakers who establish the guidelines should consider the benefits and risks of an additional dose of vaccine in the primary series not only for those with severe or untreated HIV, but also include those with moderate immune suppression or even all persons with HIV," says study first author Sally Coburn, a post-doctoral fellow in the Bloomberg School's Department of Epidemiology.

Althoff and colleagues are following up with a study to determine whether vaccinated people with HIV have not only higher breakthrough infection rates but also higher hospitalization rates after breakthrough infection.

Excerpt from:

Risk of breakthrough COVID-19 infection higher among people with HIV - The Hub at Johns Hopkins

After more than a year with two types of COVID-19 vaccines in use in the United States, another will be up for consideration by the U.S. Food and Drug Administration this week.The FDA's vaccine advisers are set to meet Tuesday to consider Novavax's coronavirus vaccine for the nation.Based on data included in an agency briefing document posted Friday, an FDA review found that the vaccine's efficacy was 90.4% overall against mild, moderate or severe COVID-19 for a period of 2 months after completing the two-dose primary series. The document notes that, in a primary analysis, the vaccine efficacy fell to 78.6% among adults 65 and older.Those efficacy numbers were collected before the emergence of the omicron coronavirus variant. It remains unclear how long protection lasts or how well the vaccine will protect against omicron.In an announcement published in December, the company reported that the vaccine had "broad cross-reactivity against omicron and other circulating variants from a primary 2-dose regimen, with responses that increased following a third dose at six months."Novavax's vaccine, called NVX-CoV2373, is given as two doses three weeks apart for the primary vaccination series.Although most adverse reactions to the vaccine were mild to moderate and lasted just a few days, the FDA did describe rare events of myocarditis and pericarditis -- inflammation of the heart muscle and inflammation of tissue surrounding the heart -- associated with the vaccine."Multiple events of myocarditis/ pericarditis were reported in temporal relationship to NVX-CoV2373 administration, similar to myocarditis following mRNA COVID-19 vaccines and raising concern for a causal relationship to NVX-CoV2373," the FDA's briefing document says.The document describes six cases that happened after vaccination with Novavax. Five were among males ranging in age from 16 to 67. Of the six cases, five were hospitalized but have since recovered.An increased risk of myocarditis and pericarditis has been identified among people who received the mRNA Pfizer/BioNTech and Moderna COVID-19 vaccines now used in the United States.In a statement Friday, Novavax addressed the heart inflammation concerns specifically: "We have learned that we can expect to see natural background events of myocarditis in any sufficiently large database, and that young males are at higher risk. Myocarditis is most often caused by nonspecific viral infections." It said that the rate of myocarditis in vaccinated participants was similar to the placebo group.The company added, "we believe there is insufficient evidence to establish a causal relationship. We will continue to monitor all adverse events, including myocarditis and pericarditis."The most common adverse reactions to the vaccine were pain at the injection site, fatigue, headache and muscle ache. Reactions were reported more commonly in younger participants in the vaccine's clinical trials.In its briefing document, the FDA summarized, "The known benefits among vaccine recipients 18 years of age and older relative to placebo are reductions in the risk of mild to severe COVID-19 occurring at least 7 days after the second primary series vaccination."In Tuesday's meeting, the FDA's vaccine advisory committee members will vote on the question: "Based on the totality of scientific evidence available, do the benefits of the Novavax COVID-19 Vaccine when administered as a 2-dose series outweigh its risks for use in individuals 18 years of age and older?"'We believe our vaccine offers a differentiated option'In late January, Novavax announced that it had submitted a request for the FDA to authorize its coronavirus vaccine for emergency use in the United States.In November, Indonesia became the first country to grant emergency use authorization of Novavax's vaccine. It has since been authorized in the European Union, the United Kingdom, Canada, South Korea, Australia, India, the Philippines and New Zealand, among other countries.Even though most adults in the United States have been vaccinated against COVID-19, the head of the company has said that it sees Novavax's vaccine as a potential option for booster doses, regardless of which type of vaccine was given for a person's initial doses.Novavax's vaccine was developed as a protein subunit vaccine, a more traditional type of technology than the mRNA used for the Moderna and Pfizer vaccines. Other examples of subunit vaccines are the hepatitis B and pertussis vaccines."We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic," Novavax CEO Stanley Erck said in a statement in January.Novavax's protein-based coronavirus vaccine relies on something called recombinant nanoparticle technology and Novavax's adjuvant, called Matrix-M, to stimulate an immune response and high levels of neutralizing antibodies.Protein-based vaccines like Novavax's work by getting the body's immune system to recognize little modified pieces of the virus it's targeting. In Novavax's case, that means pieces of the coronavirus spike protein.When the genetic sequence for the virus that causes Covid-19 was published, scientists around the world quickly identified it as a coronavirus because of the "spike proteins" on its surface. These spikes form large protrusions, giving coronaviruses the appearance of wearing crowns, and "corona" is the Latin word for "crown."Novavax scientists identified the gene for the spike protein and created a modified version of that gene. The researchers cloned the genes into a baculovirus that infects insects. They then infected moth cells -- specifically, cells from the fall armyworm -- prompting them to produce the coronavirus spike protein.These virus-like nanoparticles were harvested to make Novavax's vaccine."The whole idea of the vaccine is to show the immune system something that looks, tastes and acts like a virus, with the exception that it doesn't make you sick. So we made the spike protein. We put it in a particle -- basically, like a soap bubble -- and it's the size of the virus," Dr. Gregory Glenn, president of research and development for Novavax, told CNN last year."It's not infectious. We never touch the coronavirus itself," Glenn added. "Then that is given to people, and they make an immune response that's very much focused just on the spike -- and I would say, the hallmark of our vaccine is, it gives a very strong immune response with very few side effects, and the dose is very small and the vaccine can be stored with normal refrigerated temperatures."Novavax starts Phase 3 trial of omicron-specific boosterAs Novavax seeks emergency use authorization of its NVX-CoV2373 vaccine, it also is studying a separate vaccine that specifically targets the omicron variant, called NVX-CoV2515. The company announced this week that it has started a Phase 3 trial of this vaccine, assessing its safety and efficacy as a booster shot."The trial will also seek to determine the antibody responses to a bivalent vaccine, containing both NVX-CoV2373 and NVX-CoV2515, administered in participants who have received a booster series of an mRNA vaccine," Novavax said in a news release.The trial will analyze the omicron-specific vaccine and a bivalent vaccine in more than 1,000 participants in Australia.Two doses of either the omicron-specific vaccine or the original NVX-CoV2373 vaccine will be given after three doses of either the Pfizer-BioNTech and/or Moderna vaccines that were received at least three months before participants joined the trial.Similarly, two doses of the omicron-specific vaccine or the original NVX-CoV2373 will be given after two doses of either mRNA vaccines received at least six months before joining the trial.Two doses of the bivalent vaccine will be administered in participants vaccinated with three doses of either mRNA vaccine at least three months before joining the trial.The trial will last about 10 months, and initial results are expected in the second half of this year.

After more than a year with two types of COVID-19 vaccines in use in the United States, another will be up for consideration by the U.S. Food and Drug Administration this week.

The FDA's vaccine advisers are set to meet Tuesday to consider Novavax's coronavirus vaccine for the nation.

Based on data included in an agency briefing document posted Friday, an FDA review found that the vaccine's efficacy was 90.4% overall against mild, moderate or severe COVID-19 for a period of 2 months after completing the two-dose primary series. The document notes that, in a primary analysis, the vaccine efficacy fell to 78.6% among adults 65 and older.

Those efficacy numbers were collected before the emergence of the omicron coronavirus variant. It remains unclear how long protection lasts or how well the vaccine will protect against omicron.

In an announcement published in December, the company reported that the vaccine had "broad cross-reactivity against omicron and other circulating variants from a primary 2-dose regimen, with responses that increased following a third dose at six months."

Novavax's vaccine, called NVX-CoV2373, is given as two doses three weeks apart for the primary vaccination series.

Although most adverse reactions to the vaccine were mild to moderate and lasted just a few days, the FDA did describe rare events of myocarditis and pericarditis -- inflammation of the heart muscle and inflammation of tissue surrounding the heart -- associated with the vaccine.

"Multiple events of myocarditis/ pericarditis were reported in temporal relationship to NVX-CoV2373 administration, similar to myocarditis following mRNA COVID-19 vaccines and raising concern for a causal relationship to NVX-CoV2373," the FDA's briefing document says.

The document describes six cases that happened after vaccination with Novavax. Five were among males ranging in age from 16 to 67. Of the six cases, five were hospitalized but have since recovered.

An increased risk of myocarditis and pericarditis has been identified among people who received the mRNA Pfizer/BioNTech and Moderna COVID-19 vaccines now used in the United States.

In a statement Friday, Novavax addressed the heart inflammation concerns specifically: "We have learned that we can expect to see natural background events of myocarditis in any sufficiently large database, and that young males are at higher risk. Myocarditis is most often caused by nonspecific viral infections." It said that the rate of myocarditis in vaccinated participants was similar to the placebo group.

The company added, "we believe there is insufficient evidence to establish a causal relationship. We will continue to monitor all adverse events, including myocarditis and pericarditis."

The most common adverse reactions to the vaccine were pain at the injection site, fatigue, headache and muscle ache. Reactions were reported more commonly in younger participants in the vaccine's clinical trials.

In its briefing document, the FDA summarized, "The known benefits among vaccine recipients 18 years of age and older relative to placebo are reductions in the risk of mild to severe COVID-19 occurring at least 7 days after the second primary series vaccination."

In Tuesday's meeting, the FDA's vaccine advisory committee members will vote on the question: "Based on the totality of scientific evidence available, do the benefits of the Novavax COVID-19 Vaccine when administered as a 2-dose series outweigh its risks for use in individuals 18 years of age and older?"

In late January, Novavax announced that it had submitted a request for the FDA to authorize its coronavirus vaccine for emergency use in the United States.

In November, Indonesia became the first country to grant emergency use authorization of Novavax's vaccine. It has since been authorized in the European Union, the United Kingdom, Canada, South Korea, Australia, India, the Philippines and New Zealand, among other countries.

Even though most adults in the United States have been vaccinated against COVID-19, the head of the company has said that it sees Novavax's vaccine as a potential option for booster doses, regardless of which type of vaccine was given for a person's initial doses.

Novavax's vaccine was developed as a protein subunit vaccine, a more traditional type of technology than the mRNA used for the Moderna and Pfizer vaccines. Other examples of subunit vaccines are the hepatitis B and pertussis vaccines.

"We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic," Novavax CEO Stanley Erck said in a statement in January.

Novavax's protein-based coronavirus vaccine relies on something called recombinant nanoparticle technology and Novavax's adjuvant, called Matrix-M, to stimulate an immune response and high levels of neutralizing antibodies.

Protein-based vaccines like Novavax's work by getting the body's immune system to recognize little modified pieces of the virus it's targeting. In Novavax's case, that means pieces of the coronavirus spike protein.

When the genetic sequence for the virus that causes Covid-19 was published, scientists around the world quickly identified it as a coronavirus because of the "spike proteins" on its surface. These spikes form large protrusions, giving coronaviruses the appearance of wearing crowns, and "corona" is the Latin word for "crown."

Novavax scientists identified the gene for the spike protein and created a modified version of that gene. The researchers cloned the genes into a baculovirus that infects insects. They then infected moth cells -- specifically, cells from the fall armyworm -- prompting them to produce the coronavirus spike protein.

These virus-like nanoparticles were harvested to make Novavax's vaccine.

"The whole idea of the vaccine is to show the immune system something that looks, tastes and acts like a virus, with the exception that it doesn't make you sick. So we made the spike protein. We put it in a particle -- basically, like a soap bubble -- and it's the size of the virus," Dr. Gregory Glenn, president of research and development for Novavax, told CNN last year.

"It's not infectious. We never touch the coronavirus itself," Glenn added. "Then that is given to people, and they make an immune response that's very much focused just on the spike -- and I would say, the hallmark of our vaccine is, it gives a very strong immune response with very few side effects, and the dose is very small and the vaccine can be stored with normal refrigerated temperatures."

As Novavax seeks emergency use authorization of its NVX-CoV2373 vaccine, it also is studying a separate vaccine that specifically targets the omicron variant, called NVX-CoV2515. The company announced this week that it has started a Phase 3 trial of this vaccine, assessing its safety and efficacy as a booster shot.

"The trial will also seek to determine the antibody responses to a bivalent vaccine, containing both NVX-CoV2373 and NVX-CoV2515, administered in participants who have received a booster series of an mRNA vaccine," Novavax said in a news release.

The trial will analyze the omicron-specific vaccine and a bivalent vaccine in more than 1,000 participants in Australia.

Two doses of either the omicron-specific vaccine or the original NVX-CoV2373 vaccine will be given after three doses of either the Pfizer-BioNTech and/or Moderna vaccines that were received at least three months before participants joined the trial.

Similarly, two doses of the omicron-specific vaccine or the original NVX-CoV2373 will be given after two doses of either mRNA vaccines received at least six months before joining the trial.

Two doses of the bivalent vaccine will be administered in participants vaccinated with three doses of either mRNA vaccine at least three months before joining the trial.

The trial will last about 10 months, and initial results are expected in the second half of this year.

More here:

FDA advisers to weigh risks and benefits of Novavax's COVID-19 vaccine - WDSU New Orleans

In a recent study review posted to the medRxiv* preprint server, researchers evaluated the economic and medical costs incurred due to the coronavirus disease 2019 (COVID-19) pandemic. They also assessed the cost-effectiveness of surveillance, response measures, and preparedness for COVID-19.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections have caused economic disruptions, loss of lives, and social disturbances with a profound impact on healthcare systems, societies, and the general population. Data on the economic impact of COVID-19 is indispensable for improving decision-making and allocating resources for enhanced preparation for COVID-19 and future pandemics.

Study: The cost of the COVID-19 pandemic vs the cost-effectiveness of mitigation strategies in the EU/UK/EEA and OECD countries: a systematic review. Image Credit:Corona Borealis Studio / Shutterstock

In the present systematic review, researchers assessed the economic burden of COVID-19 on healthcare systems, societies, the general population, and within-population subgroups in Europe, the United Kingdom, and member nations of the European environment agency (EEA) and the organization for economic cooperation and development (OECD).

Studies published in the EMBASE and Ovid Medline databases between January 1, 2020, and April 22, 2021, were selected to determine the costs incurred due to COVID-19 and the cost benefits of pharmaceutical and non-pharmaceutical interventions (NPIs). Public health preparedness measures or interventions were compared to cost of inaction/no intervention and cost of preparedness vs. cost of response. The outcome measures of economic evaluations included cost for each life-year gained, the cost for each quality-adjusted life-year (QALY) achieved, and the cost for cases averted with the interventions. In addition, the incremental cost-effectiveness ratio (ICER) was evaluated.

For the analysis, first, the costs were inflated from the original year to 2021, using the gross domestic product (GDP) deflator index of the International Monetary Fund World Economic Outlook Database. Subsequently, the original currency was converted to 2021 Euros, using the Purchasing Power Parities (PPP) values for GDP. The dominance ranking matrix (DRM) was used to assess the cost-effectiveness of the interventions of the selected studies.

Out of 10,314 studies identified, the entire text of 403 full-text studies was screened, from which 362 studies with unmet inclusion criteria were excluded. As a result, 41 studies were selected for the final review, of which 20 studies, 10 studies, and 11 studies were of high, good, and medium quality, respectively. Ten studies assessed the costs of the SARS-CoV-2 pandemic, and 31 studies evaluated the cost-benefits of surveillance, preparedness, and measures taken in response to COVID-19.

In Italy, the temporary and permanent productivity losses due to COVID-19 were estimated at 1,029 per case and 84,836 per death, respectively. Higher costs were incurred during the initial COVID-19 phase due to vaccine unavailability. In Ohio, the cost of lives lost was ~7.8 billion . For children hospitalized due to COVID-19 in Korea, the total costs were 252,389 and for inpatient settings, the cost was estimated at 19,513 during eight months of hospitalization.

The costs were higher (21,850 ) in case of intensive care unit (ICU) admissions without invasive mechanical ventilation (IMV) and even higher (62,139 ) if ICU and IMV are used. Likewise, in Turkey, the cost per ICU patient was much higher than ward patients and was estimated at 2,322 and 700 for 15 days and nine days of hospitalization, respectively.

In Australia, the cost estimates for delays in COVID-19-related cancer treatment initiation by three months and six months were >6 million and >25 million , respectively. In Europe, COVID-19 treatment costs were higher for obese and diabetic individuals. Initiating treatment at an effective reproduction number (Re) of 3.5 was cost-effective from the societal perspective when treating 75% of symptomatic cases (ICER 2,690 /QALY saved) and from the third payer perspective when >50% of all patients were treated (ICER 6,267 /QALY saved).

Quarantine for symptomatic individuals further reduced costs. With home isolation, the costs were estimated at 5% of the US GDP, with maximum cost savings in the case of a 45-day isolation period and 90% compliance. The cost per life-year saved for non-strict and strict physical restriction policies for 26 weeks was 206,888 and 1,553,988 , respectively. For a basic reproduction number (R0) of 2, the optimal strategy was daily testing and 14-day-isolation. On contrary, for lower R0 (1.5 to 1.8) values, weekly testing and one-week isolation were optimal.

Further, community testing, saliva sampling, and testing of all symptomatic individuals improved cost-minimization than standard hospital testing, nasopharyngeal swab sampling, and testing only COVID-19 patients requiring hospitalization. The cost per infection averted by home-based antigen tests was 6,266 and daily screening with subsequent polymerase chain reaction (PCR) tests also reduced costs. Personal protective equipment (PPE) investments of 7.6 billion , dexamethasone treatment, and provision of ICU beds reduced the economic impact of COVID-19.

In Israel, national lockdowns improved health outcomes by reducing deaths; however, the economic burden increased with estimated costs of 36,568,451 per death averted, and 3.6 million costs per QALY gained. Complete lockdown for four months (further extended for three months) resulted in costs of 116 billion and the gradual lifting of restrictions would reduce GDP by 697,121 /life-year saved.

The estimated losses for the three-month mitigation scenario and suppression scenario were 13.5% and 22% in GDP, respectively. Suppression policies were associated with an ICER of <56 972 . In the United States (US), the universal vaccination approach was more cost-saving than the risk-stratification approach from the societal perspective (estimated cost savings of 395 million ); however, the latter was more cost-effective from the healthcare perspective.

Overall, the study findings highlighted the economic burden of SARS-CoV-2 on healthcare systems, societies, the general population, and specific population subgroups and showed that ICU bed provision policies, community screening, vaccination, and investing in PPE were cost-effective in most cases.

medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.

Journal reference:

Continued here:

COVID-19's economic impact on healthcare systems, societies, and the population - News-Medical.Net

Based on data included in an agency briefing document posted Friday, an FDA review found that the vaccine's efficacy was 90.4% overall against mild, moderate or severe Covid-19 for a period of 2 months after completing the two-dose primary series. The document notes that, in a primary analysis, the vaccine efficacy fell to 78.6% among adults 65 and older.

Those efficacy numbers were collected before the emergence of the Omicron coronavirus variant. It remains unclear how long protection lasts or how well the vaccine will protect against Omicron.

Novavax's vaccine, called NVX-CoV2373, is given as two doses three weeks apart for the primary vaccination series.

Although most adverse reactions to the vaccine were mild to moderate and lasted just a few days, the FDA did describe rare events of myocarditis and pericarditis -- inflammation of the heart muscle and inflammation of tissue surrounding the heart -- associated with the vaccine.

"Multiple events of myocarditis/ pericarditis were reported in temporal relationship to NVX-CoV2373 administration, similar to myocarditis following mRNA COVID-19 vaccines and raising concern for a causal relationship to NVX-CoV2373," the FDA's briefing document says.

The document describes six cases that happened after vaccination with Novavax. Five were among males ranging in age from 16 to 67. Of the six cases, five were hospitalized but have since recovered.

An increased risk of myocarditis and pericarditis has been identified among people who received the mRNA Pfizer/BioNTech and Moderna Covid-19 vaccines now used in the United States.

The company added, "we believe there is insufficient evidence to establish a causal relationship. We will continue to monitor all adverse events, including myocarditis and pericarditis."

The most common adverse reactions to the vaccine were pain at the injection site, fatigue, headache and muscle ache. Reactions were reported more commonly in younger participants in the vaccine's clinical trials.

In its briefing document, the FDA summarized, "The known benefits among vaccine recipients 18 years of age and older relative to placebo are reduction in the risk of mild to severe COVID-19 occurring at least 7 days after the second primary series vaccination."

In Tuesday's meeting, the FDA's vaccine advisory committee members will vote on the question: "Based on the totality of scientific evidence available, do the benefits of the Novavax COVID-19 Vaccine when administered as a 2-dose series outweigh its risks for use in individuals 18 years of age and older?"

'We believe our vaccine offers a differentiated option'

In late January, Novavax announced that it had submitted a request for the FDA to authorize its coronavirus vaccine for emergency use in the United States.

In November, Indonesia became the first country to grant emergency use authorization of Novavax's vaccine. It has since been authorized in the European Union, the United Kingdom, Canada, South Korea, Australia, India, the Philippines and New Zealand, among other countries.

Even though most adults in the United States have been vaccinated against Covid-19, the head of the company has said that it sees Novavax's vaccine as a potential option for booster doses, regardless of which type of vaccine was given for a person's initial doses.

Novavax's protein-based coronavirus vaccine relies on something called recombinant nanoparticle technology and Novavax's adjuvant, called Matrix-M, to stimulate an immune response and high levels of neutralizing antibodies.

Protein-based vaccines like Novavax's work by getting the body's immune system to recognize little modified pieces of the virus it's targeting. In Novavax's case, that means pieces of the coronavirus spike protein.

Novavax scientists identified the gene for the spike protein and created a modified version of that gene. The researchers cloned the genes into a baculovirus that infects insects. They then infected moth cells -- specifically, cells from the fall armyworm -- prompting them to produce the coronavirus spike protein.

These virus-like nanoparticles were harvested to make Novavax's vaccine.

"It's not infectious. We never touch the coronavirus itself," Glenn added. "Then that is given to people, and they make an immune response that's very much focused just on the spike -- and I would say, the hallmark of our vaccine is, it gives a very strong immune response with very few side effects, and the dose is very small and the vaccine can be stored with normal refrigerated temperatures."

Novavax starts Phase 3 trial of Omicron-specific booster

"The trial will also seek to determine the antibody responses to a bivalent vaccine, containing both NVX-CoV2373 and NVX-CoV2515, administered in participants who have received a booster series of an mRNA vaccine," Novavax said in a news release.

The trial will analyze the Omicron-specific vaccine and a bivalent vaccine in more than 1,000 participants in Australia.

Two doses of either the Omicron-specific vaccine or the original NVX-CoV2373 vaccine will be given after three doses of either the Pfizer-BioNTech and/or Moderna vaccines that were received at least three months before participants joined the trial.

Similarly, two doses of the Omicron-specific vaccine or the original NVX-CoV2373 will be given after two doses of either mRNA vaccines received at least six months before joining the trial.

Two doses of the bivalent vaccine will be administered in participants vaccinated with three doses of either mRNA vaccine at least three months before joining the trial.

The trial will last about 10 months, and initial results are expected in the second half of this year.

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FDA advisers to weigh risks and benefits of Novavax's Covid-19 vaccine - CNN

The World Health Organization (WHO) has announced the start of the Covid-19 vaccination campaign across Afghanistan in the coming days.

The Corona virus vaccine implementation campaign, according to the WHOs plans, will begin in June of this year, the organization announcedin a tweet yesterday, May 26.

The process will cover 34 provinces in Afghanistan, with more than five million people over the age of 18 receiving the corona vaccination, according to the World Health Organization.

Since the inception of the Corona virusvaccine program, over 8.5 million people have been vaccinated, according to the latest figures released to the media by the Taliban-led governments Ministry of Public Health.

According to the spokesperson for Ministry of Public Health, 4.6 million people have been vaccinated within last nine months alone.

According to the World Health Organization, around 178,996 people have been infected with Corona Virusin Afghanistan since the outbreak began, with 7,685 fatalities.

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WHO to Immunize Over 5 Million Covid-19 Vaccinations Across Afghanistan - The Khaama Press News Agency - The Khaama Press News Agency

Monkeypox outbreak won't be the next global pandemic thanks to vaccines, drugs: analysts  FiercePharma

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Monkeypox outbreak won't be the next global pandemic thanks to vaccines, drugs: analysts - FiercePharma

Background and objective

Since being declared a global pandemic, coronavirus disease 2019 (COVID-19) has led to millions of cases and deathsworldwide. Although severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to wreak havoc on individuals, healthcare systems, and economies, the intensive vaccination strategies adopted by several countries have significantly slowed the progress and the severity of the disease. In this study, we aimed todetermine the COVID-19 vaccination status among healthcare workers (HCWs)and examine the effects of vaccination on disease manifestations.

This cross-sectional study was conducted at a teaching hospital in NortheastIndia from April 2021 to September 2021, during the second phase of the COVID-19 pandemic. HCWs employed in the hospital who were laboratory-confirmed cases of COVID-19 based on semiquantitative real-time reverse transcriptase-polymerase chain reaction (RT-PCR) or cartridge-based nucleic acid amplification test (CBNAAT) on oropharyngeal samples were included in the study. Data analysis was performed using Microsoft Excel (Microsoft Office Professional Plus 2019, Microsoft Corp., Redmond, WA)

A total of 178 HCWs reported positive for COVID-19 infection during the study period. Of these, 42 (23.59%) were males and 136 were females (76.40%).Among them, 86 (48.32%) HCWs were fully vaccinated, 58 (32.58%) were partially vaccinated, and 34 (19.10%) were not vaccinated.Most of the HCWs experienced mild disease (145, 81.46%), and only four (2.24%) reported moderate to severe disease. Compared with unvaccinated HCWs, individuals who have had either one or twodoses of vaccines were less likely to have moderate to severe disease or seek treatment at the hospital. On symptoms analysis, shortness of breath was found to be more common in unvaccinated individuals than in vaccinated patients, and anosmia and loss of taste were more common in vaccinated than in unvaccinated individuals. No deaths were reported among the participants included in this study.

Following the first and second waves of the COVID-19 pandemic, a substantial proportion of HCWs were infected with SARS-CoV-2, likely as a result of the acquisition of the virus in the community during the early phase of local spread. Fully vaccinated individuals with COVID-19 were more likely to be completely asymptomatic or only mildly symptomatic compared to unvaccinated HCWs.

Coronavirus diseases 2019 (COVID-19) is caused by a novel coronavirus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) [1]. It was first reported in Wuhan, Hubei Province, China in December 2019 [2]. Since the onset of the COVID-19 pandemic, more than 238 million people have been infected, leading to more than 4.8 million mortalities, as ofOctober 9, 2021 [3]. In the absence of any specific treatment against the COVID-19 virus, vaccination remains the only viable option to combat this pandemic for now. The United States Food and Drug Administration (USFDA) gave its firstapproval for a vaccine against the COVID-19onDecember 11, 2020, on an emergency use authorization basis, for the COVID-19 mRNA vaccine (BNT162b2). As ofOctober 9, 2021, more than 6.47 billion doses of various COVID-19 vaccines have been administeredworldwide [4]. Due to the shortage of vaccines in the immediate aftermath of the initial rollout of vaccines, only those people at high risk of getting an infection or at risk of developing severe disease were vaccinated on a priority basis. Healthcare workers (HCWs) directly involved in the care of COVID-19 patients face a higher risk of getting infected in comparison to the general population [5]. Hence, they were the first group of people to be vaccinated against COVID-19. In India, vaccination against COVID-19 was started on January 16, 2021, and as ofOctober 9, 2021, more than 946 million doses of vaccine have been administered [6]. However, like in the case of any other vaccine, there has been vaccination hesitancy amongthe HCWs regarding the COVID-19 vaccine as well and, as a result, there have been many cases where HCWs diagnosed with COVID-19 were found to be unvaccinated[7].

Individuals diagnosed with COVID-19 may have protean manifestations and different clinical needs [8]. There have been scarce data from NortheastIndia regarding the COVID-19 pandemic[9-11]. Analysis of symptom profiles among individual COVID-19patients following vaccination is valuable in terms of clinical utility, assessment and identification of risk groups (e.g., long COVID) for intervention, and the appropriate use of testing guidelines [12]. Against this background, the present study was conducted during the second wave of COVID-19 in India, which was mostly attributed due to the emergence of the Delta variant of the COVID-19 virus [13]. Our objectives were as follows: (1) to determine the COVID-19 vaccination status among HCWs at the time of COVID-19 diagnosis, and (2) to study the effect of the COVID-19 vaccination ondisease manifestations.

The study was conducted at a tertiary care medical teaching institute in the state of Meghalaya in Northeast India. The study included cases diagnosed during the period from April 2021 to September 2021, which coincided with the second wave of the COVID-19 in the state of Meghalaya. Only those HCWs who are working in the institute where the study was conducted were included, and they were followed up for at least three weeks from the date of diagnosis. The study included 178laboratory-confirmed cases of COVID-19 based on either semiquantitative real-time reverse transcriptase-polymerase chain reaction (RT-PCR) or cartridge-based nucleic acid amplification test (CBNAAT) on oropharyngeal samples. All patients were under the direct supervision of the treating institute. Patients who were treated outside the institute were excluded from the study. For the purpose of comparison, the cases were classified into three groups based on the vaccination status:

Category-A: Nonvaccinated - Patients who were either not vaccinated or received their first dose of vaccine within seven days of the diagnosis of COVID-19.

Category-B: Partially vaccinated - Patients who either received the first dose of vaccineeight or more days prior to the COVID-19 diagnosis or received the second dose of vaccine within seven days of the diagnosis of COVID-19.

Category-C: Fully vaccinated - Patients who received the second dose of vaccine eight or more days prior to the diagnosis of COVID-19.

Data related todemographic details, vaccination status, clinical manifestations, and disease outcomes were collected. Ethical approval was obtained from the Institution Ethics Committee, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences vide letter No. NEIGR/IEC/M15/F20/2021 dated August 28, 2021, and informed written consent was obtained from allstudy participants.

A totalof 178 cases were included in the present study. Of them, 42 (23.59%) were males and 136 (76.40%) were females, with a male-to-female ratio of 0.31:1. Most of the study patients were nursing officers (n=102, 57.30%) followed by resident doctors (n=37, 16.29%), technicians (n=17, 7.86%), housekeeping staff(n=12, 6.74%), and faculty members (n=10, 5.62%). The number of cases in Category-A, Category-B, and Category-C was 58 (32.58%), 34 (19.10%), and 86 (48.32%) respectively. All those who were vaccinated had received only Covishield [ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant)] manufactured by the Serum Institute of India Pvt Ltd. The vaccination status among the different categories of the staff at the time of COVID-19 diagnosis is shown in Table 1. Characteristics such as the mean age, gender distribution, and severity of disease in the different categories are shown in Table 2.

Figure 1 illustrates symptoms in various categories of HCWs who were diagnosed with COVID-19.

In the absence of an effective and sustainable infection control strategy and the non-availability of a specific treatment against the COVID-19, effective vaccination remains the only viable option to fight against the COVID-19 pandemic. The sense of urgency to have an effective vaccine against COVID-19 coupled with great human effort has led to the development of multiple vaccines against COVID-19within a year of the first reported case of the ongoing COVID-19 pandemic. As of February 2022, India has authorized three vaccines against SARS-CoV-2: Covishield (AstraZeneca's vaccine manufactured by the Serum Institute of India), Covaxin (manufactured by Bharat Biotech Limited), and Sputnik V [14]. But coronaviruses are known to undergo genetic mutation as they propagate, and it has happened in the case of SARS-CoV-2 as well,resulting in the appearance of multiple variants of the virus leading to multiple waves of increased cases and reinfections [15-18]. The appearance of multiple variants also has the potential to render the existing vaccines ineffective [19].

Even though vaccines against COVID-19 were made available within the shortest possible period, many people including HCWs remained hesitant to get vaccinated due to doubts regarding the efficacy and safety of the available vaccines. In the present study, 32.59% of HCWs had not received any dose of vaccine at the time of COVID-19 diagnosis, 19.10% were partially vaccinated, and only 48.31% were completely vaccinated. Among the categories of HCWs, the housekeeping staff was the most unvaccinated group followed by the nursing staff. Doctors including faculty members and residents were predominantly vaccinated at the time of COVID-19 diagnosis. Vaccine hesitancy was found to be higher among the nursing staff and housekeeping staff in the present study, which is similar to the findings reported in other studies [20,21].

All HCWs in the fully vaccinated category had either mild disease or were asymptomatic. Among the partially vaccinated or completely unvaccinated, 4.34% of cases developed moderate to severe disease. No mortality was reported in the present study in any of thecategories. Similar findings were reported by other studies where most of the HCWs with breakthrough infections after receiving the Oxford-Astra Zeneca vaccinewere either asymptomatic or had mild disease [22,23].

In a study by Teranet al. involving 75 skilled nursing care facilities in Chicago, among 627 persons with SARS-CoV-2 infection since vaccination began, 22 (4%) were identified as residents and staff members of skilled nursing facilities. On further analysis, nearly two-thirds (14/22, 64%) of the patients were found asymptomatic with two COVID-19-related hospitalizations and one death [24]. Similar results were also reported by different studies across India; however, none of these studies reported any deaths related to COVID-19 among HCWs who received two doses of the vaccine (Table 3) [25-28]. The possible hypothesis for this post-vaccination COVID-19 infection could be ascribed to the emergence of new COVID-19 variants, which may bypass vaccine-induced immunity [29]. It is reassuring that the majority of infections seen in our facility were either asymptomatic or mild.

Based on our findings, COVID-19 vaccination acceptance is not uniform among the different categories of the HCWs. Vaccination acceptance is almost universal among doctors but less among the nursingand housekeeping staff. Those who were completely vaccinated were found to have negligible levels of serious disease when compared to those who were either unvaccinated or incompletely vaccinated.These findings suggest that widespread and effective vaccination among HCWs provides a safe environment, even in the setting of a high rate of SARS-CoV-2 infection in the community.

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COVID-19 Vaccination Status Among Healthcare Workers and Its Effect on Disease Manifestations: A Study From Northeast India - Cureus

Researchers find that mRNA vaccines fare better against COVID-19 variants of concern. Credit: Carlos Reusser Monsalvez

A comparison of four COVID-19 vaccinations shows that messenger RNA (mRNA) vaccines Pfizer-BioNTech and Moderna perform better against the World Health Organization (WHO)s variants of concern (VOCs) than viral vector vaccines AstraZeneca and Johnson & Johnson (J&J)/Janssen. Although they all effectively prevent severe disease by VOCs, the research, publishingtoday (May 17th, 2022) in the open access journal PLOS Medicine, suggests that people receiving a viral vector vaccine are more vulnerable to infection by new variants.

By March 2022, COVID-19 had caused over 450 million confirmed infections and six million reported deaths. The first vaccines approved in the US and Europe that protect against serious infection are Pfizer-BioNTech and Moderna, which deliver genetic code, known as mRNA, to the bodies cells, whereas Oxford/AstraZeneca and J&J/Janssen are viral vector vaccines that use a modified version of a different virus a vector to deliver instructions to our cells. Three vaccines are delivered as two separate injections a few weeks apart, and J&J/Janssen as a single dose.

Marit J. van Gils at the University of Amsterdam, Netherlands, and colleagues, took blood samples from 165 healthcare workers, three and four weeks after first and second vaccination respectively, and for J&J/Janssen at four to five and eight weeks after vaccination. Samples were collected before, and four weeks after a Pfizer-BioNTech booster.

Four weeks after the initial two doses, antibody responses to the original SARS-CoV-2 viral strain were highest in recipients of Moderna, followed closely by Pfizer-BioNTech, and were substantially lower in those who received viral vector vaccines. Tested against the VOCs Alpha, Beta, Gamma, Delta, and Omicron neutralizing antibodies were higher in the mRNA vaccine recipients compared to those who had viral vector vaccines. The ability to neutralize VOCs was reduced in all vaccine groups, with the greatest reduction against Omicron. The Pfizer-BioNTech booster increased antibody responses in all groups with substantial improvement against VOCs, including Omicron.

The researchers caution that their AstraZeneca group was significantly older, because of safety concerns for the vaccine in younger age groups. As immune responses tend to weaken with age, this could affect the results. This group was also smaller because the Dutch government halted use for a period.

van Gils concludes, Four COVID-19 vaccines induce substantially different antibody responses.

Reference: Antibody responses against SARS-CoV-2 variants induced by four different SARS-CoV-2 vaccines in health care workers in the Netherlands: A prospective cohort study by van Gils MJ, Lavell A, van der Straten K, Appelman B, Bontjer I, Poniman M, et al., 17 May 2022, PLOS Medicine.DOI: 10.1371/journal.pmed.1003991

Funding: This work was supported by the Netherlands Organization for Scientific Research (NWO) ZonMw (Vici grant no. 91818627 to R.W.S., S3 study, grant agreement no. 10430022010023 to M.K.B.; RECoVERED, grant agreement no. 10150062010002 to M.D.d.J.), by the Bill & Melinda Gates Foundation (grant no. INV002022 and INV008818 to R.W.S. and INV-024617 to M.J.v.G.), by Amsterdam UMC through the AMC Fellowship (to M.J.v.G.) and the Corona Research Fund (to M.K.B.), and by the European Unions Horizon 2020 program (RECoVER, grant no. 101003589 to M.D.d.J). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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mRNA COVID-19 Vaccines Like Pfizer and Moderna Work Better Against Variants of Concern - SciTechDaily

By Jondi Gumz

Denmark is the first country to suspend its Covid vaccination program, with the health authority citing the arrival of spring, and more people have had either Covid or a vaccine 89% over the age of 12 are fully vaccinated, and 76% of adults have a booster shot.

The India Supreme Court issued a landmark ruling supporting vaccine choice, saying that bodily integrity is protected under Article 21 (Right to Life) of the constitution and no individual can be forced to be vaccinated.

In the U.S., Dr. Vinay Prasad, who has a masters in public health, suggests vaccine choice be available to parents of children under 5 for which the Food and Drug Administration has not authorized a Covid vaccine. Moderna submitted trial results and applied for emergency use authorization, and Pfizer is awaiting trial results, but Prasad tweets, Why have FDA? Let the marketplace decide.

The highly contagious but less deadly BA.2 Omicron subvariant now dominates, a change from the initially deadly coronavirus.

Cases are up, and there is an uptick in hospitalizations in California, and locally, but public health officers say its hard to predict a peak and how dangerous this variant is, given that some people have natural immunity.

The federal Centers for Disease Control and Prevention estimates almost 60 percent of the populace including 76% percent of children have had Omicron or another coronavirus variant.

California Parents United and Moms on the Ground announced a parents rights initiative and candidate forum 6-8 p.m. May 19, at a Salinas ranch, 484 Corral de Tierra Road. Tickets are $100 at http://www.californiaparentsunited.org. Mama Bears Radio Show on KSCO is a co-sponsor.

New signs of normal: Cabrillo College in Aptos brings back in-person graduation Friday, May 20, seating at 2 p.m., ceremony at 4 p.m. at the football stadium on campus. In-person graduation ceremonies June 2 for Aptos Junior High, 11 a.m., and Aptos High, 4 p.m. both at Cabrillos football stadium.

The Aptos Chamber bringing back the Worlds Shortest Parade at 10 a.m. July 4. The theme is team spirit. The chamber also is seeking vendors for the party in the Aptos Village Park, which will be 11 a.m. to 4 p.m. with music, craft booths, and food.

The Felton Remembers parade returns at 10 a.m. May 28 followed by the Covered Bridge Festival. Starting June 16, the Santa Cruz Beach Boardwalk brings back live music Thursdays on the Colonnade with Friday night movies starting June 17.

The city of Scotts Valley is seeking help to host its Independence Day parade a day early, Sunday, July 3, with a fireworks celebration that night.

Proposed Laws

California lawmakers face a May 27 deadline to pass legislation; 10 bills deal with Covid-19.

Four were pulled Assembly Bill 1993, to require all employees and independent contractors, public and private, to be vaccinated against Covid-19 to keep their job and Senate Bill 871, to require children 0-17 to get a Covid vaccine to attend school or day care.

Also pulled: SB 1464, to require law enforcement officers to enforce public health orders, and cut funding if they do not and shift those funds to public health, SB 1390 to prohibit a social media platform from amplifying misinformation or disinformation and SB 920, to authorize a medical board to inspect a doctors office and records without patient consent.

Protection of the Educational Rights of Kids, headed by Amy Bohn in Newbury Park, which has filed six lawsuits against vaccine mandates, is watching to see if these measures come back in a budget trailer bill in May which avoids public hearings. The group is tracking other Covid-19 bills. They include:

To track these bills, see https://leginfo.legislature.ca.gov

With SB 871 pulled by the author, Gov. Newsom is delaying plans to mandate Covid vaccine for school children until July 2023.

Hospitalizations from Omicron had peaked in January, then plummeted and have been rising.

The state Department of Public Health reports test positivity, 23% in January, has ticked up from 1.7% to 4.4% and hospitalizations 20,000 in January dropped to 950 before rising to 1,300.

Santa Cruz County reports 1,379 active cases, with five hospitalizations, one in intensive care. One Covid death was reported in the past two weeks, bringing the total to 262. That person was 85 or older, with other medical conditions.

In April, the Cal/OSHA Standards Board adopted new workplace rules.

Unvaccinated and vaccinated workers must be treated the same; no mask mandate for those unvaccinated. Requirements to disinfect surfaces were removed. Requirements for partitions and physical distancing were replaced by requirements for better ventilation. Employees testing positive can return to work masked five days later.

Omicron has a shorter incubation period then the early coronavirus variants.

Airline Mask Mandate Lifted

Starting May 16, the European Union will no longer require masks at airports and on airplanes. Passengers coughing or sneezing should consider wearing a mask to safeguard others, officials said.

Airline masks became optional in the U.S. after a federal judge in Florida on April 18 voided the mask mandate ordered by the federal Centers for Disease Control and Prevention for airlines, trains and buses on Feb. 3, 2021.

The Justice Department appealed at the CDCs request but the agency did not ask for a stay, which would have reinstated the mandate.

U.S. District Judge Kathryn Kimball Mizelle ruled in favor of Health Freedom Defense Fund and airline travelers Ana Carolina Daza and Sarah Pope, who claimed the CDC failed to provide a 30-day comment public period required for new regulations.

Mizzell provided a 59-page explanation, based on the Public Health Services Act of 1944, which specifies sanitation as a measure that could be necessary to prevent disease from spreading, but has no definition of sanitation.

Wearing a mask cleans nothing, the judge wrote. At most it traps virus droplets. But it neither sanitizes the person wearing the mask nor sanitizes the conveyance.

The government interprets sanitation to mean applying of measures for preserving and promoting public health. The judge disagreed, writing that historically, public health has been regulated at the state level, and the 1944 law has no clear language that Congress intended the CDC to take over.

The CDC did not allow public comment although the Administrative Procedures Act requires agencies provide a 30-day comment period on new rules.

The CDC did not explain mask exemptions for people eating, drinking or taking medication or for children under age 2. By not explaining, the CDC action was arbitrary and capricious, the judge ruled.

After ordering masks, the CDC did not conduct a study to generate scientific evidence that wearing cloth masks slows spread on an airplane.

The CDCs Covid-19 map shows most counties green for low transmission. New York State, Vermont and Connecticut all have high transmission. Santa Cruz County and neighboring Santa Clara County are medium.

Santa Cruz County, which updates its dashboard on Monday and Thursday, reports 1,379 active cases, on the rise but down from the peak of 10,000.

Omicron Less Deadly

The Omicron variants are less deadly than the Delta variant, which raged in 2021.

Santa Cruz County reported 37 Covid deaths after Omicron, compared to 225 as of Dec. 15, before Omicron.

One statistic is similar: 79% to 81% of those who died had pre-existing conditions.

Why do people fear Omnicron?

They may have a pre-existing condition (diabetes, obesity, asthma, high blood pressure).

Half of Americans do, so they are at higher risk for severe Covid illness.

So are people 85 and older.

California reports 83.3% of residents age 5 and up have had at least one shot.

On the CDC Covid tracker, Santa Cruz County reports 90.8% of residents age 5 and up have at least one shot and 82.9% fully vaccinated.

Pajaro Valley Schools

The Pajaro Valley Unified School District reports 92 active student cases and 19 staff cases in May. Aptos High has 18 student cases and 2 staff cases. Aptos Junior High has 10 student cases and one staff case. Valencia Elementary has 8 student cases and 1 staff cases. Rio del Mar Elementary has 6 student cases and zero staff cases. Mar Vista Elementary has 1 student case and 1 staff case.

The state guidance to schools and childcares as of March 11. Masks are not required but strongly recommended.

Santa Cruz County Office of Education, with Inspire Diagnostics, has provided 472,100 tests.

Cases in local schools peaked at 4,407 on Jan. 27, dropped to 44 on April 1, then rose to 455 on May 11. The 14-day positivity rate, 12.25% on January, dropped to .79%, then rose to 3.16%.

Fully vaccinated means having two shots (Pfizer or Moderna) or one Johnson & Johnson shot. All were developed for the initial Wuhan Covid-19 strain.

For Omicron, a booster shot is needed after the Pfizer vaccine, because protection against hospitalization wanes after three months, a Kaiser Permanente study of 11,000 hospital admissions and emergency room visits found.

Vaccine Database

In a 2022 report in the Journal of American Medical Association online, Dr. Matthew Oster of the CDC reported the governments VAERS database received 1,991 reports of myocarditis after one dose of mRNA-based Covid-19 vaccine and 1,626 met the CDCs definition for probable or confirmed myocarditis.

Osters conclusion: The risk of myocarditis after receiving mRNA-based Covid-19 vaccines was increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men. This risk should be considered.

The 2022 NFL Scouting Combine changed its COVID-19 policies after agents representing more than 150 draft prospects began organizing a boycott of testing, workouts and interviews at the event in response to the leagues bubble restrictions, according to a memo obtained by The Athletic.

The changes allowed players to leave the bubble during free time or have approved medical personnel, athletic trainers and massage therapists join them in secure areas.

Public health officials say the scientific consensus is that Covid vaccines are safe, but some are skeptical about relying on science from drug-makers, which saw profits rise in 2021. They point to the U.S. government database, https://vaers.hhs.gov/, where health care providers are to report adverse events after a vaccine.

The reporting site was created after Congress passed a law in 1986 protecting vaccine manufacturers from civil personal injury lawsuits and wrongful death lawsuits resulting from vaccine injuries.

Health and Human Services Secretary Alex Azar invoked the Public Readiness and Emergency Preparedness Act, a 2005 law allowing him to provide legal protection to companies making or distributing critical medical supplies such as vaccines unless theres willful misconduct by the company. This protection lasts until 2024.

Renz Law, representing military whistleblowers, sued the federal government to lift the vaccine mandate for military personnel and appeals for passage of legislation repealing immunity for vaccine manufacturers.

If vaccines are truly safe and effective no one should oppose this, the lawsuit reads.

After mRNA COVID-19 vaccines were mandated for the military in 2021, cases of heart attack, pulmonary embolism, cancers, and myocarditis spiked dramatically, according to the Defense Military Epidemiological Database queries by the whistleblowers.

The Department of Defenses response was that a glitch in the database affected the data from 2016-2020.

Myocarditis is inflammation of the heart, which can lead to clots, a stroke or heart attack.

Dr. Pamela Popper, whose group supported the lawsuit, posts updates at https://makeamericansfreeagain.com/

Testing

The Santa Cruz County Office of Education offers drive-though testing for students, staff and families at:

Cabrillo College, Aptos, Parking Lot K, Monday to Friday 9 a.m. to 5 p.m. and Saturday 9 a.m. to 3 p.m.

Santa Cruz County Office of Education, 399 Encinal St., Santa Cruz, Monday to Friday, 9 to 5 p.m. Saturday, 9 a.m. to 3 p.m.

See: https://tinyurl.com/get-tested-santa-cruz.

Booster shots: https://myturn.ca.gov/

Vaccine providers: http://www.santacruzhealth.org/coronavirusvaccine.

Local information: http://www.santacruzhealth.org/coronavirus or (831) 454-4242 from 8 a.m. to 5 p.m. Monday through Friday.

Total COVID cases: 1,379

COVID Deaths: 262As of May 12

Age85 and older: 113 75-84: 61 65-74: 46 60-64: 15 55-59: 4 45-54: 10 35-44: 8 25-34: 5

Underlying ConditionsYes: 212 No: 50

RaceWhite 150 Latinx 89 Asian 16 Black 3 Amer Indian 1 Hawaiian 1 Another 2

GenderMen: 135 Women: 127

LocationAt facility for aged: 116 Not at a facility: 146

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Living with Covid: Graduation in Person - TPG Online Daily