Category: Covid-19 Vaccine

Transcript:

John F. DiPersio, MD, PhD: The last question I had is not related to chronic GVHD [graft-versus-host disease] but involves these patients. What are you doing for patients who are out a year or 2 and grafted but develop chronic GVHD on low levels of immunosuppression, maybe a JAK [janus kinase] inhibitor, etcetera, for COVID-19? Are you just vaccinating them and watching them? Are you vaccinating them and watching their anti-COVID-19 spike protein antibody titers or are you actually giving them EVUSHELD even though they're far out and they may only be on a JAK inhibitor? Pashna?

Pashna N. Munshi, MD: In our program, with our ID [infectious disease] colleagues, we decided that all our immune-compromised patients, whether they're within 100 days or out 1 year or 2 years, all of them are getting the EVUSHELD protection. Obviously, if they're chronic GVHD patients by now, we hope that they've already been vaccinated and had their booster and then we are checking the spike protein level in their body for antibody response. And then, what I'm seeing is happening is that our ID colleagues are recommending that they have to alternate between their shield and then another booster down the road to keep their levels up. And thus, we're trying to do that for our patients.

John F. DiPersio, MD, PhD: It sounds like your ID people are as confused as ours. What are you doing in MGH [Massachusetts General Hospital]?

Yi-Bin Chen, MD: We don't have an organized algorithm partly because it's such a rapidly changing environment. When certain antibodies we had now don't work based on strain and then access to these things has been somewhat restricted and centrally managed and not at the discretion of, say, me. I think that in general, I worry about our long-term chronic GVHD patients more than any other transplant population because most of our fresh transplant patients now are receiving grafts from vaccinated donors. And there's some adaptive immunity that's transferred, whereas these chronic GVHD patients who are transplanted years ago never had any immunity against COVID-19. And if they're on immunosuppression like the drugs we listed, they certainly have an impaired ability to respond.

Thus, I worry about them the most. Thankfully, that the strains present right now seem to have become less severe and that's been helpful. But from an immunity perspective, we obviously recommend vaccination but there is what we've experienced and I'm sure you've seen what has been reported as well as the flares of chronic GVHD that can happen with any vaccine. Not just COVID-19 but vaccines certainly seem to trigger a severe inflammatory response. That for some of our patients they've experienced severe flares of chronic GVHD. We do give EVUSHELD, certainly, and then we do measure the spike antibodies and then we have trials coming up using other monoclonal antibody products as well. It's unfortunate because we don't have an organized treatment algorithm but that's also because of how fast this is changing.

John F. DiPersio, MD, PhD: Hannah, maybe you can answer this last response for the panel today. What are you doing at [The] Ohio State University?

Hannah Choe, MD: For the COVID-19?

John F. DiPersio, MD, PhD: Yes.

Hannah Choe, MD: It's a mix of the same thing. We certainly hinge everything on vaccination as much as possible so regardless of the immunosuppression and understanding that ruxolitinib and other immunosuppressants we were using limit the patient's ability to mount a response; we're still giving the 3 full doses plus a booster. And then, probably shortly here, we are going to be giving another booster once the FDA [Food and Drug Administration] approves that. And then, in certain cases, depending on patient history, considering EVUSHELD. We are not broadly using EVUSHELD and for the same reason that Yi-Ben just mentioned is that we are not sure about the efficacy with the current strain and future strain, etcetera.

John F. DiPersio, MD, PhD: I think it's also that the EVUSHELD studies were done in immunocompetent patients and so there's no extension. You can't make an obvious extension into our patients, but it's well tolerated, and I do agree with you, Yi-Bin. Even with regular vaccinations as well as with the COVID-19 vaccinations, there can be significant flares in chronic GVHD, and it's always been one of my pet peeves about the regular vaccinations. Really, how much benefit are we doing especially if you have a one in 10 out of patients that have a real flare in their chronic GVHD? In any event, we do it obviously and we see the same thing with the covert vaccinations and so I do use EVUSHELD on these patients because I do think that they're immunocompromised for a long time, years and years after transplant, especially if they're on immunosuppression. But I have no evidence that this is protective, especially in this population of patients.

I've really enjoyed listening to the panel's responses to these questions and teaching me about chronic GVHD and acute GVHD. It's been a great hour and I really want to first and foremost thank Pashna, Yi-Bin, and Hannah for their participation in this panel. You guys were great, and I really learned a lot and I want to thank the viewing audience for sticking with us for the last hour. And I hope that you've been provided with some helpful insights and some hints about how to manage this very difficult disease to both diagnose and treat. And with that, I'll bid you all adieu. Thank you very much.

Transcript edited for clarity.

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Perspectives on COVID-19 Prophylaxis and Vaccination - Cancer Network

Transparency and clear guidance about COVID boosters are critical to maintaining public support and trust.

"Moving to a regular vaccine schedule will increase clarity and confidence about what actions to take and when, compared to the current piecemeal, wait-and-see approach," said Marcus Schabacker, MD, PhD, president and CEO of ECRI. "Transparency and clear guidance are critical to maintaining public support and trust."

ECRI experts say mental fatigue and a desire for normalcy are likely driving increasing COVID apathy. They say unclear guidance and near-constant changes regarding who, when, and how often individuals need boosters can magnify this apathy and cause the public to completely disengage.

"For mRNA vaccines, boosters can be safely administered at regular intervals to address emerging variants, similar to the flu vaccine," said Marcus Lynch, PhD, MBA, senior manager of clinical excellence and safety at ECRI. "A regular booster schedule may help promote uptake, further decreasing COVID's prevalence."

According to ECRI, one of the main goals of vaccination boosters in an endemic is to reduce the prevalence of a virus to levels that make it possible for society to live with it. The best way to do so, experts say, is with a regular booster schedule guided by evidence and data.

ECRI's position statement, From Pandemic to Endemic: The Role of COVID-19 Vaccine Boosters and the Need for a Recurring Vaccination Schedule, is available for public download on ECRI's website.

For additional information, visit http://www.ecri.orgor contact ECRI at [emailprotected].

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About ECRIECRI is an independent, nonprofit organization improving the safety, quality, and cost-effectiveness of care across all healthcare settings. With a focus on technology evaluation and safety solutions, ECRI is respected and trusted by healthcare leaders and agencies worldwide. For more than fifty years, ECRI has built its reputation on integrity and disciplined rigor, with an unwavering commitment to independence and strict conflict-of-interest rules.

ECRI is the only organization worldwide to conduct independent medical device evaluations, with labs located in North America and Asia Pacific. ECRI is designated an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality. ECRI and the Institute for Safe Medication Practices PSO is a federally certified Patient Safety Organization as designated by the U.S. Department of Health and Human Services. The Institute for Safe Medication Practices (ISMP) formally became an ECRI Affiliate in 2020. Marcus Schabacker, MD, PhD, President and CEO of ECRI, was recognized by the Philadelphia Business Journal as a Healthcare Leader in 2021. Visit http://www.ecri.org and follow @ECRI_Org.

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ECRI: It's Time to Move to a Scheduled COVID-19 Vaccine Booster Model - PR Newswire

For Immediate Release: May 17, 2022

Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 Vaccine.

While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease, said FDA Commissioner Robert M. Califf, M.D. The FDA is authorizing the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age to provide continued protection against COVID-19. Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe. If your child is eligible for the Pfizer-BioNTech COVID-19 Vaccine and has not yet received their primary series, getting them vaccinated can help protect them from the potentially severe consequences that can occur, such as hospitalization and death.

On Jan. 3, the FDA authorized the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for administration to individuals 12 through 15 years of age after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine. Todays action expands the use of a single booster dose of the vaccine for administration to individuals 5 through 11 years age at least five months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine. The FDA has authorized the Pfizer-BioNTech COVID-19 Vaccine for use in individuals 5 years of age and older and has approved Comirnaty (COVID-19 Vaccine, mRNA) for use in individuals 16 years of age and older.

The Pfizer-BioNTech COVID-19 Vaccine is effective in helping to prevent the most severe consequences of COVID-19 in individuals 5 years of age and older, said Peter Marks, M.D., Ph.D., director of the FDAs Center for Biologics Evaluation and Research. Since authorizing the vaccine for children down to 5 years of age in October 2021, emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations. The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age at least five months after completing a primary series outweigh its known and potential risks and that a booster dose can help provide continued protection against COVID-19 in this and older age groups.

Data Supporting Effectiveness

The EUA for a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age is based on FDAs analysis of immune response data in a subset of children from the ongoing randomized placebo-controlled trial that supported the October 2021 authorization of the Pfizer-BioNTech COVID-19 Vaccine primary series in this age group. Antibody responses were evaluated in 67 study participants who received a booster dose 7 to 9 months after completing a two-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine. The antibody level against the SARS-CoV-2 virus one month after the booster dose was increased compared to before the booster dose.

FDA Evaluation of Safety

The safety of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine in this age group was assessed in approximately 400 children who received a booster dose at least five months (range 5 to 9 months) after completing a two-dose primary series. The most commonly reported side effects were pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain and chills and fever.

The FDA did not hold a meeting of its Vaccines and Related Biological Products Advisory Committee on todays action, as the agency previously convened the committee for extensive discussions regarding the use of booster doses of COVID-19 vaccines and, after review of Pfizers EUA request, the FDA concluded that the request did not raise questions that would benefit from additional discussion by committee members. The FDA will make available on its website relevant documents regarding todays authorization.

The amendment to the EUA was granted to Pfizer Inc.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

05/17/2022

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Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years | FDA -...

RICHLAND, Wash. (AP) A federal judge has dismissed a lawsuit brought by several hundred Hanford nuclear reservation and Pacific Northwest National Laboratory workers in Richland, Washington, over COVID-19 vaccine requirements.

The lawsuit was filed in November to halt enforcement of President Joe Bidens executive orders requiring COVID-19 vaccinations for Department of Energy employees and the employees of contractors and subcontractors on federal projects, The Tri-City Herald reported.

But U.S. Judge Thomas Rice found that lawyers for the Hanford and national lab workers had not provided clear arguments nor specific information about most workers to make their case.

With the original complaint already changed once, Rice had no confidence in another amended complaint after their continued failures to address the shortcomings in their various pleadings, he said in his order dismissing the case. The case has been argued by Nathan Arnold of Seattle and Pete Serrano, a Pasco city council member and director and attorney for the Silent Majority Foundation in Pasco, which organized the lawsuit.

Rice had already refused to temporarily halt enforcement of the vaccine mandates while the lawsuit proceeded. The judge said 307 of the workers in the case had not shown they were harmed by the vaccine mandate or that a decision in their favor would redress any harm.

Many had not filed for religious or medical exemptions allowed by the mandates, Rice said. Others had filed but failed to provide information to the court on their exemption or vaccination status.

Without knowing whether these plaintiffs are in compliance with the vaccination or exemption requirements, it is impossible to know whether they could face an adverse employment action, Rice said.

Other plaintiffs failed to say who employed them, giving them no standing in the case. That left just seven plaintiffs in the case with possibly valid claims.

Attorneys argued that the vaccine mandates violated the U.S. Constitution. But Rice found that a closer examination of the claims reveals only broad recitations of various constitutional principles muddled with repetitive allegations that the executive orders were promulgated in excess of President Bidens authority.

Claims based on freedom of religion did not hold up because plaintiffs did not identify the religious activities they were engaged in or how those activities were substantially burdened by the executive orders, Rice said. Rice also found that the vaccine mandates or a valid exemption were a requirement for employment, but no one had been forced to get a vaccine, he said.

DOE hires contractors to do most of the work at the Hanford site, with the large majority of the 11,000 workers at the nuclear reservation employed by contractors and subcontractors. The claimants in the lawsuit included some DOE employees, but mostly contractor and subcontractor employees.

The 580-square-mile (1,502-square-kilometer) Hanford nuclear reservation in Eastern Washington was used from World War II through the Cold War to produce nearly two-thirds of the plutonium for the nations nuclear weapons program.

About $2.5 billion annually is spent on environmental cleanup of the contaminated site. Pacific Northwest National Laboratory is a Department of Energy Office of Science laboratory in Richland operated by Battelle under an Energy Department contract. It employs about 5,350 people and has an annual budget of about $1.25 billion.

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Judge tosses COVID-19 vaccine objections of Hanford workers - knkx.org

The World Health Organization, with the support of the Strategic Advisory Group of Experts (SAGE) on Immunization and its COVID-19 Vaccines Working Group, continues to review the emerging evidence on the need for and timing of additional booster doses for the currently available COVID-19 vaccines which have received Emergency Use Listing (EUL). The statements and conclusions in this document will be updated as new data become available.

The objective of this statement is to review the evidence on additional booster doses. In considering additional booster doses, there are two main scenarios to assess: 1) the use of additional booster doses in those who are not able to mount and sustain adequate immune responses and 2) considerations for additional booster doses to be administered in order to protect high risk populations and health workers in order to maintain the health system during periodic waves of disease surges.

WHO's current Recommendations: (1) initial booster doses:

Booster doses should be offered based on evidence that doing so would have substantial impact on reducing hospitalization, severe disease and death, and to protect health systems. The order of implementing booster doses to different population groups should follow that which has been laid out for the primary vaccination series i.e., booster doses should be prioritized for higher priority-use groups before lower priority-use groups, unless there is adequate justification not to do so. Such justification may include programmatic constraints or acceptability obstacles to uptake in higher priority-use groups that would result in vaccine wastage. In such cases, strategies should be prioritized to improve vaccine delivery, community engagement, and social mobilization efforts to reach higher priority-use groups.

Within a given priority-use group, primary series vaccination will have greater impact per dose than additional doses. Across priority-use groups, the benefits of additional doses for higher priority-use groups versus primary series doses for lower priority-use groups depends on country conditions, including supply and roll-out timelines, past epidemic dynamics and infection-induced immunity, vaccine product, vaccine effectiveness, and waning of protection. When high primary series coverage rates have been achieved among subgroups at higher risk of severe disease and death (e.g., older adults), additional doses for these subgroups may yield greater reductions in severe disease and death than use of equivalent vaccine supply for primary series vaccination of lower priority-use groups.

The optimal interval between completion of a primary series and administration of additional doses has yet to be determined, and depends on epidemiological setting, vaccine product, targeted age groups, background seroprevalence, and circulation and frequency of specific variant of concerns (VoC). As a general principle, an interval of 46 months since completion of the primary series could be considered, especially in the context of Omicron.

Booster doses should be considered for all COVID-19 vaccines having received EUL as per WHOs product specific interim recommendations.

WHO`s current Recommendations: (2) Additional Doses in Immunocompromised persons

Available data for WHO EUL COVID-19 vaccine products suggest that vaccine effectiveness and immunogenicity are lower in immunocompromised persons (ICPs), compared to persons without immunocompromising conditions. An additional dose included in an extended primary series enhances immune responses in some ICPs (2, 3). Given the significant risk of severe COVID-19 for ICPs, if infected, WHO has already issued a recommendation for an extended primary series (i.e. third dose) as well as a booster dose (i.e. fourth dose) for ICPs, for all COVID-19 vaccines (1, 4). Homologous (same vaccine platform) and heterologous (different vaccine platform) vaccines can be used for such booster doses (5).

Considerations for additional booster doses beyond the first booster (< 6 months since first booster)

Additional booster doses beyond the first booster dose are currently being offered by some countries (i.e. fourth dose to older adults and a fifth dose for immunocompromised persons). Data on the usefulness of these additional booster doses is sparse and especially limited on the duration of further protection. Data on additional booster doses as of May 2022 only exists for the mRNA vaccines, and not for other vaccine platforms. Hence, in the following we only focus on the evidence with regards to additional booster for mRNA vaccines, while encouraging more data to be accrued for all vaccine platforms.

Seven studies were available for review, six of which were from Israel (6-11) and one from Canada (12). All were conducted during a time when Omicron has been the predominant circulating strain globally. While the studies vary in their design and population investigated, most evaluated the relative effectiveness of a fourth dose 4 months after a 3rd dose of mRNA vaccine compared to those who received 3 doses. This relative vaccine effectiveness only provides evidence on the value of a fourth dose compared to individuals who already have some vaccine induced protection (3 dose recipients). The relative vaccine effectiveness depends upon the initial VE provided by 3 doses and how much subsequent waning has occurred. In contrast, earlier studies provide an absolute vaccine effectiveness comparing vaccinated versus unvaccinated individuals. The Canadian study is the only available study that provides data on absolute vaccine effectiveness (i.e., compares 4th dose schedule to those who are unvaccinated). Additionally, the maximum follow up in the available studies was short and ranged from two weeks to ten weeks after the fourth dose.

Of the seven studies that investigated the use of a 4th dose of mRNA COVID vaccine, two reported specifically on outcomes of infection and any symptomatic disease (10, 11). Both studies were conducted in Israel and included health workers (HWs) as their population of interest. One study showed an increased IgG antibodies against SARS-CoV-2 receptor-binding domain and neutralizing antibody titers by a factor of 9-10 measured after fourth dose of vaccine. This corresponded to antibody titers that were slightly higher than those achieved after the third dose, with no significant difference between the two mRNA vaccines (11). The second study investigated breakthrough infections in HWs who received 3 doses of BNT162b2 vaccine and provided a comparison to those who received a fourth dose of BNT162b2. In fourth dose recipients, there was a reduction in breakthrough infection rates compared to that observed after only a 3rd dose of mRNA vaccine (10).

Of the remaining five studies, all were conducted in individuals older than 60 years of age, excluding individuals who had previous SARS-Co-2 infection and specifically evaluated mRNA vaccines. Two of the studies were retrospective cohort studies using administrative data. The first study found that the relative vaccine effectiveness against severe disease to be 66% (95% CI, 57-72) 15 to 21 days after a fourth dose and 77% (95% CI, 62-86) 36-42 days after a fourth dose (6). The second retrospective cohort study reported on death as the outcome measure and found a relative vaccine effectiveness of 78% (95% CI 72-83) 7 or more days post fourth dose. The absolute risk reduction conferred by the fourth dose was 0.07% in the study (9). The third study used a test negative design and reported on severe disease. They found a relative vaccine effectiveness of 87% (95% CI 0-98) 49-69 days post fourth booster. This study reported that severe disease was a relatively rare event, occurring among <1% of both fourth dose and third dose only recipients (8). The fourth study reviewed was a target trial (application of trial design principles from RCTs to the analysis of observational data(13)) that provided outcome data for hospitalization, severe disease and death. They found a relative vaccine effectiveness of 62% (95% CI, 50 to 74) against severe COVID-19, and 74% (95% CI, 50 to 90) against COVID-19 related death comparing 3 dose recipients to 4 dose recipients. A further analysis of the risk of severe COVID-19 from 7 days to 30 days post fourth dose was 42.1 events per 100,000 persons, as compared with 110.8 events per 100,000 persons in the 3 dose recipient control group. This corresponds to a difference in risk of 68.8 cases per 100,000 persons (95% CI, 48.5 to 91.9)(7).

The final study, conducted in Canada, investigated not only the relative vaccine effectiveness but also the absolute vaccine effectiveness when compared to unvaccinated individuals, two dose recipients as well as three dose recipients. This study found that with each additional dose, VE increased for severe disease. Absolute VE was 82% (95%CI 75-88%) as measured more than 84 days after third dose, and 92% (95%CI 87-95%) for fourth dose recipients at greater than 7 days after the fourth dose (12).

Taken together, these studies show some short-term benefit of an additional booster dose of mRNA vaccine in health workers, those over 60 years of age or with immunocompromising conditions. Data to support an additional dose for healthy younger populations are limited; preliminary data suggest that in younger people, the benefit is minimal. Moreover, follow-up time after the additional booster dose was limited, thereby precluding conclusions about duration of protection after this dose. Therefore, there is a lack of data to guide some important questions for making policy decisions. The limited available data suggest that for highest risk groups there is a benefit that supports the administration of an additional booster dose.

Administering an additional booster dose likely comes with considerable programmatic challenges in terms of vaccine delivery in many settings. The financial and opportunity cost of such programmes must also be carefully weighed against the limited incremental benefit of an additional booster dose. In those most at risk for severe disease or death (i.e. adults above the age of 60 years, or those who are not able to mount a full immune response), the additional benefit of an additional booster dose of mRNA vaccine might be warranted.

Considerations for future additional doses:

For longer-term considerations, there are significant uncertainties related to the evolution of the virus and the characteristics of future variants. Given widespread transmission of Omicron globally, continued viral evolution with the emergence of new variants or sub lineages as is already being seen. Development of a pan-SARS-CoV-2 or pan-sarbecovirus vaccines are needed, but the timeframe for their development is uncertain (14). Meanwhile, the composition of the currently available COVID-19 vaccines may need to be updated to offer better protection against new VOCs which may be antigenically distinct (14). Current vaccines based on the index virus appear to maintain high VE against severe disease also in the context of current variants of concerns, but VE estimates against infection and symptomatic diseases are lower against Omicron. Any update to vaccine composition would aim to elicit greater breadth in the immune response against circulating and emerging variants, in addition to retaining protection against severe disease and death. The performance of any updated vaccine(s) may vary depending on the nature and magnitude of previously acquired immunity, recognizing that this immunity will be dependent upon different VOCs, different types of vaccines and their timing of administration.

While seasonality is not yet fully established for SARS-COV-2, evidence from the past two years support the notion of more substantial transmission during the winter season. Therefore, for countries with either a Northern or Southern Hemisphere winter season, plans for catch-up to improve primary series coverage and boosting for those at highest risk, campaigns should take seasonality into account. In addition, in view of the uncertainty of the characteristics of new VOC, which may emerge rapidly, there may be value in establishing vaccine induced immunity using existing vaccines (i.e. index virus) complemented by a booster dose of variant vaccine to broaden the immunological response. The Technical Advisory Group on COVID-19 Vaccine Composition will provide advice on updated vaccine composition when data is available.

To that end, in order to make sound policy decisions, data will need to be generated on the performance of current and variant-specific candidate COVID-19 vaccines, including the VE, immunogenicity and safety of an additional booster dose over time and by disease outcome and priority use groups. More research is needed on the breadth, magnitude, and durability of humoral and cell-mediated immune responses to variants. Also needed is evidence to address other gaps in the evidence regarding the need for additional booster doses, which includes the duration of VE of inactivated, subunit and viral vectored vaccines over time and by disease outcome. Finally, an understanding of the vaccine correlates of protection and correlates of durability of protection in persons with and without previous COVID-19 infection would assist policy makers in creating sound programmatic decisions.

SAGE as well as the Technical Advisory Group on COVID-19 Vaccine Composition continue to monitor the situation carefully and the WHO position will be updated accordingly.

References:

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Interim statement on the use of additional booster doses of Emergency Use Listed mRNA vaccines against COVID-19 - World Health Organization

Georgias vaccination rates rank among the lowest among states. Georgia ranks 45th in the U.S.

Omicron subvariants are beginning to gain traction and increase infections in Georgia. According to the most recent data from the state Department of Public Health, the seven-day moving average for confirmed infections was 839 cases on May 3, which is about double the infection rate from three weeks prior. Data after May 3 is preliminary, but it appears the uptick will continue, building to a predicted summer surge in the South that is typically seen as hotter weather drives more people indoors.

Studies have shown the boosters, recommended for five months after the initial vaccines are finished, can boost immunity in children 5-11.

Metro Atlantas largest school districts are all planning to provide in-person instruction for the fall semester. Some districts, like Clayton County, are offering virtual learning options for the families of students who request it.

Some individual classrooms are pivoting to virtual-only learning during periods of COVID-19 outbreaks. Atlanta Public Schools said two fourth-grade classes are online only due to a significant number of positive cases and symptomatic individuals identified through the week, among students and staff. Those classes shifted to online-only learning options Friday and plan to return to the physical classroom on Thursday.

Staff writer Vanessa McCray contributed to this story

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Georgias COVID-19 vaccination rate for young kids lags behind rest of U.S. - The Atlanta Journal Constitution

Brazzaville Thousands of clinical trials conducted in different parts of the world have shown that COVID-19 vaccines are safe and efficacious. So why do we continue to study the performance of these vaccines such as a recent one done in Zambia if we already know this?

COVID-19 vaccines were tested in controlled clinical settings where there were very strict rules for enrolling participants in the studies. So it is important for us to study how these vaccines perform in the real world. This is where vaccine effectiveness studies come into the picture, says Dr Jason Mwenda, head of the African Region Monitoring COVID-19 Vaccine Effectiveness (AFRO-MoVE) network at World Health Organization (WHO) Regional Office for Africa.

Vaccine effectiveness studies tell us things we do not yet really know about COVID-19 vaccines and are part of the process of ongoing scientific investigation. For example, what happens to vaccine performance when someone misses a dose, doesnt follow the prescribed timing between a first and second dose or uses a different vaccine for the first or second doses? What happens if a vaccine is not stored in the correct conditions or is delivered off-schedule to far-flung areas? Clinical trials were conducted at a time when the world had yet to encounter the Beta, Delta or Omicron variants, so how are vaccines performing against these variants?

These are just some of the important questions that vaccine effectiveness studies all over the world have already started to answer, showing that vaccines continue to be effective since clinical trial data became available and diseases patterns change.

But, to date, only three of the 272 vaccine effectiveness studies published worldwide have been in the African region.

To address this gap, WHO Regional Office for Africa established the AFRO-MoVE network in February 2021. Thirty partners including the national institutes of public health, ministries of health and research institutions in 18 African countries participate in the network. WHO is currently funding four of the 19 ongoing or planned studies in 14 countries in Africa, through a grant from the Bill and Melinda Gates Foundation.

So far, results from a few studies show promising results. In Zambia, four vaccine effectiveness studies have been ongoing since June 2021 among different groups of vaccinated people, including health workers, and by analysing data gathered for countrys the respiratory disease surveillance system.

In Zambia, vaccine effectiveness studies have showed that COVID-19 vaccines reduce the risk of infection, symptomatic infection, and the risk of dying while you are in the hospital during periods when Delta and Omicron variants were circulating, says Dr Jonas Hines from the United States Centres for Disease Control and Prevention and the principal investigator for the studies.

In South Africa, studies are ongoing among people who have been hospitalized with lower respiratory tract infections and, like Zambia, researchers are leveraging data from the countrys pneumonia surveillance sites. Nicole Chiwandire, from the National Institute for Communicable Diseases in South Africa and co-principal investigator of the studies, is buoyed by the fact that three studies published in South Africa already show high vaccine effectiveness against hospitalization and/or deaths during the Beta, Delta and Omicron periods.

Results of a vaccine effectiveness study among health workers in Windhoek, Namibia, will be available later in 2022. Study participants were followed up for six months at two of the largest state hospitals in the Khomas region of Namibia.

Most of the health workers in Namibia are from the Khomas region and the two hospitals serve as a point of care for severe and critical cases, which are referred from lower-level hospitals. This makes our study site an ideal setting for a vaccine effectiveness study among health workers, says Natasha Nghitukwa, a medical officer in the Ministry of Health and Social Services in Namibia, and co-principal investigator of the study.

While the results of more studies come online, it is critical that COVID-19 vaccination continues to ramp up on the continent. Vaccination coverage remains low, with only 17.3% of the population fully vaccinated. Cases and deaths are dropping, and some may think that COVID-19 is no longer a risk. However, in the face of a fifth wave in some countries, the case for COVID-19 vaccination remains strong. Research shows that unvaccinated people are 11 times more likely to die from COVID-19 than vaccinated people.

The more data and analysis we have, the better information we will have on COVID-19 vaccine effectiveness in Africa. This will bolster the WHOs efforts to ensure that people on our continent are protected from COVID-19 and other vaccine-preventable diseases, says Dr Mwenda.

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Moving forward the science of COVID-19 vaccine effectiveness in Africa - WHO | Regional Office for Africa

Weve already debunked claims that COVID-19 vaccines cause AIDS, contain "HIV lipid wrappers" and have eight strains of HIV, and that the United Kingdom government has reports that suggest "the fully vaccinated" are rapidly developing AIDS.

A May 15 blog post doubles down on this misinformation with a sensational headline: "Your Government quietly confirmed the Fully Vaccinated are developing Acquired Immunodeficiency Syndrome while they had you worried about Russia-Ukraine & the cost of living."

This is wrong, which is why the post was flagged as part of Facebooks efforts to combat false news and misinformation on its News Feed. (Read more about our partnership with Facebook.)

"Something is very wrong, and it is because of the Covid-19 injections," the post says. "All around the world, Governments are publishing official data that all show the same thing. Those same Governments however are not willing to explain why."

But while the post makes lots of allegations, theres no evidence to support the claim that governments, including the U.S. government, have said that people vaccinated against COVID-19 are developing AIDS.

COVID-19 vaccines dont cause HIV or AIDS, or make people more susceptible to them. The vaccines bolster the immune system, not weaken it.

A spokesperson for the UK Health Security Agency told PolitiFact last year that "COVID-19 vaccines do not cause AIDS."

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According to the Centers for Disease Control and Prevention, "there is no association between COVID-19 vaccines and risk for HIV infection."

Medical experts have echoed this.

There is "no way" any COVID-19 vaccine can cause HIV infection or AIDS, Dr. David Wohl, an infectious disease expert specializing in HIV research told us.

We rate this post Pants on Fire!

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Still no connection between COVID-19 vaccines and AIDS - PolitiFact

May 16, 2022

OSWEGO COUNTY - The Oswego County Health Department continues to hold vaccination clinics each Tuesday and on the second Wednesday of each month.

Vaccine clinics will be held each Tuesday afternoon from 12:30 to 3:30 p.m. at the Nick Sterio Public Health Clinic in Oswego. Clinics will be held at the same location the second Wednesday of each month, from 9 to 11 a.m. and 1 to 3 p.m., starting May 11.

Tuesday clinics, which are by appointment only, offer general childhood and adult immunizations, including eligible COVID-19 vaccines. Wednesday clinics are dedicated to COVID-19 vaccines for eligible individuals.

COVID-19 vaccines are also available at medical provider offices and local pharmacies. Anyone seeking general immunization information, or a COVID-19 vaccine, can contact the Oswego County Health Department at 315-349-3547.

The Centers for Disease Control and Prevention (CDC), U.S. Food and Drug Administration (FDA) and New York State Department of Health (DOH) recommend individuals remain up to date on COVID-19 vaccines, which now include second booster doses for certain individuals.

Second booster doses of the Pfizer-BioNTech or Moderna COVID-19 vaccines have been approved for individuals aged 50 and older and individuals aged 12 and older who have certain immunocompromised conditions. Anyone receiving their second booster dose must be at least four months removed from their first booster shot.

Anyone aged 18 or older who received the Janssen/Johnson & Johnson COVID-19 vaccine as both primary shot and booster dose is also eligible for a second booster dose with the Pfizer-BioNTech or Moderna vaccines, regardless of health status, four months after their first booster dose was administered.

All second booster doses must be Pfizer-BioNTech or Moderna vaccines at this time. For more information about booster doses, visit https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html.

To view a list of upcoming clinics, visit health.oswegocounty.com/vaccines. The following upcoming clinics are scheduled:

Anyone needing assistance to make an appointment can contact the countys COVID-19 Hotline Monday through Friday, 8:30 a.m. to 4 p.m. at 315-349-3330. Seniors aged 60 and over who need help making an appointment can also contact the Office for the Aging at 315-349-3484.

At-home COVID-19 test kits will be distributed to individuals who are vaccinated at upcoming clinics while supplies last.

Face masks are required at all health care settings regulated by the state Department of Health, including the Oswego County Health Department and any vaccination site.

For more information, go to the Oswego County Health Departments COVID-19 page at health.oswegocounty.com/COVID-19 or call the COVID-19 hotline at 315-349-3330.

Residents should contact their medical providers directly for personal medical advice related to COVID-19 vaccinations, booster shots or treatments.

Under New York State Public Health Law, the Oswego County Health Department is the local public health authority regarding the COVID-19 pandemic response within the County of Oswego. The Oswego County Health Department works closely with New York State Department of Health regarding COVID-19 monitoring, response and reporting.

See more here:

County Health Department Offers Vaccines for COVID-19 and Other Immunizations - Oswego County

Booster Clinic on Tuesday, May 24 at the Civic Center, register HERE!

COVID-19 Vaccine: Safe, Effective, FreeThe COVID-19 vaccines continue to be remarkably effective in reducing the risk of severe disease, hospitalization, and death. CDC recommends everyone ages 5 and older get a COVID-19 vaccine to help protect against COVID-19. The Pfizer vaccine is approved for individuals age 5 and older while Moderna and Johnson & Johnson vaccines are approved for ages 18 and up.

Vaccine InformationFor information about the vaccine, safety, clinics, FAQs, and more:

Where Can I Make an Appointment?

Onondaga County Clinic Details:

After receiving your vaccine, pleaseregister for v-safe, a smartphone-based tool that provides personalized health check-ins so you can quickly tell CDC if you have any side effects or report side effects through the CDC Vaccine Adverse Event Reporting System (VAERS).

Primary Series and Booster Dose of COVID-19 Vaccines

Two doses of Moderna (28 days apart); booster 5 months after second dose OR

Single dose of Johnson & Johnson (J&J); booster 2 months after single dose

Booster 3 months after your third dose of Pfizer (ages 12+) or Moderna (ages 18+), or 2 months after your second dose of J&J vaccine (ages 18+).

Consult with your healthcare provider for further guidance.

Booster DosesA COVID-19 booster shot is an additional dose of vaccine to help maintain a level of immunity for longer. CDC advises people to get the same booster as their initial vaccine but allows people to mix and match due to availability or preference. Learn more here about boosters and see the chart below for more details (click image for full-size version).

Second Booster Dose: As of March 29, 2022, a second booster is recommended for certain people. This second booster dose (Pfizer or Moderna vaccine only) is given at least 4 months after the first booster. Those who are eligible include:

Learn More Vaccine Q&A Flyer ENGLISH | ARABIC | SPANISH | NEPALESE | SOMALI | SWAHILI New York State COVID-19 Vaccine Program CDC COVID-19 Vaccine FAQ Pfizer Vaccine Moderna Vaccine Janssen/Johnson & Johnson Vaccine

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COVID-19 Vaccine Information Onondaga County COVID-19 Info