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Berlin, Ohio, US Holmes County in northeastern Ohio is a typical Midwestern community in the United States.
Large red barns dot the rolling landscape. Trucks carrying freshly cut lumber boom through village streets. Woods and lakes dominate the landscape between villages named Berlin, Strasburg and Dresden.
But in many ways, this is a place far from typical: At a time when approximately 77 percent of the wider United States population has received at least one dose of a COVID-19 vaccine, only about 19 percent of Holmes County residents have one of the lowest county-level rates in the country.
Approximately half of Holmes Countys 50,000 residents are members of the Amish community, a traditional Christian group that largely eschews modern technology and farms land in rural areas mainly in Ohio, Pennsylvania and New York.
Living an agrarian, communal lifestyle with faith and family ties at its core, few Amish community members in the county have been vaccinated, experts quoted in local media reports have suggested.
As the US surpassed one million COVID-19 deaths on Tuesday, according to Johns Hopkins University data, and as serious side effects from getting vaccinated initially a leading cause of hesitancy are found to be rare, 67 percent of Americans are fully vaccinated.
But that still means more than 100 million people have not received a COVID-19 vaccination, despite efforts from a diverse group, ranging from local health clinics to the White House, encouraging people to do so. Health experts have said taking all three vaccinations currently available to Americans is the best way to avoid COVID-19 hospitalisation and death.
Marcus Yoder, who runs a local heritage centre in Berlin, a village in the heart of Ohio Amish country, attributed the low vaccination rate in Holmes County to many of the same reasons people across the Appalachia region are not getting vaccinated.
One is a concern about government control; people also hear negative things in the media, he told Al Jazeera. Theres also a pragmatism people are saying, Well, Ive already had the virus, whats the point of getting vaccinated?'
The county has one of the lowest COVID-19 infection rates in the US, but experts believe that reflects a near absence of testing and reporting. Local health officials in Holmes County last year reported having to add new wings to their medical centres to cope with surges in infections.
According to the countys annual health report for 2021, close to one-quarter of all Holmes County deaths last year were COVID-19 related, compared with a US-wide rate of 13 percent.
While officials at the Holmes County Health District declined to speak to Al Jazeera, the total number of reported deaths in 2020 and 2021 in the county rose by nearly a third compared with 2019. As in other communities, that increase is likely attributable to COVID-19.
None of the Amish residents of Holmes County who shared their views on vaccinations and masks with Al Jazeera wished to be named. One woman working at a used book store in Berlin said she was unsure about the jabs safety, having heard from friends that it could cause significant side effects. I have heard of many people getting the virus even after they got vaccinated, she said.
Holmes County health officials have reached out to local members of the clergy, Amish community leaders and held clinics in rural areas in an effort to boost vaccinations. But continued low vaccination rates suggest those efforts have not worked; in October,Holmes County Health Commissioner Michael Derr was quoted by local media as saying, Were inching away at it.
Randy Kaesberg, who lives in Holmes County but is not Amish, said he was aware of the areas low vaccination rate, but was trying not to be concerned. Concern is a strong word. Im aware of it. I dont want to be concerned about things I cant control, he told Al Jazeera.
Kaesberg and his wife run a local store in Berlin, where unvaccinated shoppers are still asked to wear a mask. I dont need others to do as I do. But a lot of other people if you dont do as they do then you get some attitude.
But vaccine hesitancy is not isolated to Ohios Amish community.
Overall, Ohio is the eighth-least vaccinated state in the country, with almost 37 percent not getting a single dose. Places across the US have similar rates. For example, in Storey County, Nevada, just less than 30 percent of the population has received one jab, according to local health figures.
You see it all over. Its just a right-wing thought that this vaccine is bad, that its going to sterilise people, that theres a microchip in it that can track you, said James Moos, a commissioner and Democrat in Montanas McCone County, where just 18 percent of residents have received a jab.
People say its been developed too quickly; well, people didnt know what was going to happen with the polio vaccine, but they did it.
He said he and his wife, as well as the countys two other commissioners both Republicans are vaccinated. But the issue of vaccinations has roiled the community. At the height of the pandemic in 2020, a local school had to cancel sports competitions due to the spread of the virus, angering parents.
He added that efforts to reach people included sending a mobile vaccination clinic around the largely rural county last year. But while the McCone County Health Center continues to offer vaccination appointments on a weekly basis, people remain hesitant. One good thing is that the health centre mandated that all its employees be vaccinated, said Moos, adding that the centre is the largest employer in the county. I dont know how they managed that.
While many areas with low vaccination rates are rural or have low population densities McCone Countys 1,700 residents live in an area larger than the state of Delaware that does not mean people have escaped the virus.
Nearly 10 percent of the country lived in areas where less than half of the adult population was vaccinated as of November 2021, a recent Pew Research report found. Death rates in these low-vaccination counties were roughly twice what they were in counties that had 80 percent or more of their population vaccinated.
Today, as the last pandemic-related restrictions are lifted across the country, the US is not out of the woods yet. The BA.2 variant, already taking hold in Europe, has been recorded to be on the rise in New York City and New York state.
But for Marcus Yoder in Holmes County, talking to and interacting with Amish friends and contacts suggests a change in attitude in the community.
He said now that most of the broader US population is vaccinated, and side effects from getting the shot are not a major concern, scepticism may be falling. People, he said, are starting to get used to the idea of being vaccinated.
Experts have also noted another symptom of long COVID prevalent in most people, which is sleep issues or insomnia.
Sleep disorders are one of the most common symptoms for patients whove had COVID-19, says Cinthya Pena Orbea, sleep medicine specialist at Cleveland Clinic.
Talking to Nexstar Media Group, she says, They report insomnia, fatigue, brain fog and sometimes we even see circadian rhythm disorders.
The circadian rhythm is an internal process that follows a 24-hour sleep-wake cycle. That said, circadian rhythm sleep disorder occurs when the body's internal clock goes haywire and does not match the immediate environment. This includes difficulty in falling asleep, waking up when you should be asleep or waking up too early and being unable to fall back to sleep.
If youve struggled to keep track of the latest coronavirus variants circulating around the world, youre not alone.
Two years since the start of the COVID-19 pandemic, weve heard of the Alpha, Beta, Gamma, Delta and Omicron variants, but a new one named after a Greek letter hasnt emerged so far this year.
Instead, a string of sublineages - or subvariants - of Omicron popped up. They basically feature different mutations in the spike protein that allows the virus to infect cells.
Unfortunately for our tired brains, those naming these new subvariants seem to have lost inspiration and we now face an alphabet soup of letters and numbers: BA.1, BA.2, BA.3, BA.4 and BA.5.
Sexy, right? But wait; there are also recombinant forms mixing several subvariants of Omicron, such as XE which is a mix of BA.1 and BA.2.
So, what do you really need to know about these subvariants? We deciphered the letters and numbers to make sense of them for you.
The World Health Organization (WHO) says its keeping close tabs on all the variations of SARS-CoV-2 - the original virus causing COVID-19 - and expects more will surface in the future.
Thats because the virus is circulating at such an intense level, Maria Van Kerkhove, the infectious disease epidemiologist who serves as technical lead for the WHOs COVID-19 response, told reporters on May 10.
What we can say is as this virus evolves, the latest variants that we have, the Omicron variants and all the sublineages are more transmissible than the last variant that is circulating, and we know that that will continue, she said.
Worldwide, the predominant Omicron subvariant right now is BA.2. And that subvariant is spreading faster than BA.1 did.
Even more transmissible than BA.1, BA.2, or the less-talked-about BA.3, are the subvariants BA.4 and BA.5.
Just bear in mind that so far in this series, the higher the number, the more contagious the subvariant.
BA.4 and BA.5 were first detected in South Africa in January and February 2022 respectively, and since then they have become the dominant variants there.
The European Centre for Disease Prevention and Control (ECDC) has now classified both BA.4 and BA.5 as "variants of concern"due to their rapid spread, particularly in Portugal.
As of May 8, the Portuguese National Institute of Health estimated that BA.5 accounted for around 37 per cent of positive COVID-19 cases and that its daily growth rate of 13 per cent would make it the dominant variant in the country within just two weeks, by May 22.
You may have already been comparing with your friends which COVID-19 strain and subvariant youve caught so far. Get ready for more of that, as were really not done with COVID-19 any time soon.
The ECDC says BA.4 and BA.5 could cause a significant overall increase in COVID-19 cases in the EU/EEA in the coming weeks and months and will soon become the dominant variants in the region.
"The currently observed growth advantage for BA.4 and BA.5 is likely due to their ability to evade immune protection induced by prior infection and/or vaccination, particularly if this has waned over time," the agency said in a statement on May 12.
It said limited data from in vitro studies looking at the blood of unvaccinated individuals previously infected with BA.1 suggest that both BA.4 and BA.5 are capable of escaping the immune protection induced by that prior BA.1 infection.
The serum of vaccinated people performed better in the Petri dish when attacked by BA.4 or BA.5, but "protection derived from currently available vaccines does wane over time against the Omicron variant," the ECDC said.
Hence the boosters weve been getting.
From what we know so far, vaccines remain highly effective against the worst outcomes, WHO stresses.
"The vaccines are holding up very well against severe disease and death, so it is absolutely critical that people get vaccinated," Van Kerkhove said.
The WHO has set a target of vaccines reaching 70 per cent of all people across all countries by June, and is especially concerned about vaccinating all health workers and frontline workers as well as people over 60 or with underlying conditions, as they are more vulnerable to serious cases of COVID-19.
While both Omicron subvariants are more contagious than previous ones, there is currently no indication they are more severe, and the WHO says studies on the topic are underway.
It says its seeing an increase in COVID-19 hospitalisations in South Africa, "but that can be expected when theres an increase in cases," according to a spokesperson.
The ECDC has a similar assessment.
"Based on the limited data currently available, no significant increase in infection severity compared to the circulating lineages BA.1 and BA.2 is expected," it said.
"However, as in previous waves, if COVID-19 case numbers increase substantially, some level of increased hospital and ICU admissions is likely to follow".
Both agencies are calling on national health authorities to remain vigilant and to continue testing populations and carrying out genome sequencing of samples, to keep tracking the spread of variants and how they might influence hospital admissions.
BA.4 and BA.5 have been reported in about 15 countries so far but only a few hundred sequences of each are available globally, the WHO said.
"Our ability to detect this is being substantially hindered because testing rates have plummeted and, in doing so, our sequencing rates have plummeted as well,"Van Kerkhove said.
"It is really important that surveillance for this virus continues, that testing remains strong, that sequencing is intelligent, and that we have good geographic representation so that we have good eyes and ears on the virus".
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.
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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Boilerplate
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
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:
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.
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
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.
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