Following the formal approval of the Pfizer COVID-19 vaccine by the Food and Drug Administration and the expected approval of additional vaccines, Kent State University, on Aug. 27, 2021, issued a COVID-19 vaccine requirement.
At this time, the requirement covers all students, faculty and staff.
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Overview
COVID-19 case numbers remain high and the winter period ahead will pose significant challenges of increased transmission and related pressure on the National Health Service. (This paper should be considered alongside the latest State of the epidemic report (September 2021).
Action is therefore needed across all sectors to ensure compliance with baseline COVID-19 mitigations, and it is vital to consider further targeted and proportionate measures that can reduce risk further. Vaccine certification is one such measure.
This paper sets out our proposals for a mandatory domestic COVID-19 vaccination certification scheme (the scheme) in advance of the Parliamentary debate and vote on 9 September.
We will continue to gather evidence from around the world on certification schemes. This will continue to inform our approach in Scotland. We will also publish a full assessment of the evidence for certification, based on the four harms model that we have used throughout the pandemic, in advance of the scheme coming into force.
Parliament is being asked on 9 September to vote on the principle and broad outline of a mandatory scheme. It will then be required to approve the regulations to be made under the Coronavirus Act 2020.
In line with our strategic intent to suppress the virus to a level consistent with alleviating its harms while we recover and rebuild for a better future', a COVID-19 vaccine certification scheme will aid us in reducing the rate and impact of transmission.
Research evidence indicates that being vaccinated reduces the risk that a person will become infected with the virus, and likely further reduces their risk of transmitting coronavirus. Ensuring only those who are vaccinated attend higher risk venues and events therefore directly reduces the risk of transmission.
Where someone does catch the virus, being vaccinated significantly reduces the likelihood of serious harm or death and in doing so alleviate pressure on the healthcare system.
As a result, certification provides a targeted and proportionate means to reduce risk while maximising our ability to keep open certain settings and events where transmission is a higher risk.
In addition, the need to be vaccinated is expected to encourage the remaining sections of the eligible population yet to be vaccinated to take up the offer of the vaccine.
The scheme will require a person seeking entry to certain venues and settings to show that they have been fully vaccinated. Fully vaccinated means vaccinated with a MHRA recognised vaccine in line with the MHRA recommended number of doses for the vaccine used and two weeks has passed for the vaccine to take effect
Initially, the scheme will not permit a negative test result to be offered as an alternative to evidence of vaccination, but this will be kept under review. At this stage, we do not consider that this would be appropriate and, indeed, could undermine one of the policy aims of the scheme, which is to increase vaccine uptake. Also, it is important at this stage to prioritise PCR lab capacity for Test and Protect purposes and while promoting regular LFD tests is an extremely important aspect of our overall approach, further work would be required on an optimal approach to incorporating testing, including consideration of the appropriateness of self-testing in this context.
We are working with a range of stakeholders to finalise the design of the scheme. These stakeholders include local government, NHS Boards and businesses/representative organisations in sectors that will be required to implement a certification scheme.
We intend the scheme to be ready to go live on 1 October 2021. This will give businesses time to prepare and more people to get vaccinated. It will also mean the scheme being introduced at the same time as the permanent digital solution for vaccination certification.
We are proposing the following exemptions:
We are developing an exemptions approval process for medical exemptions. This will be finalised and published ahead of implementation.
It is estimated that fewer than 1 in 1,000 people (0.1%) of the population cannot be vaccinated for medical reason (distinct from those exempt due to age or participation in a clinical trial). Reasons may include medical contraindications such as severe allergic reaction to vaccine and those receiving end of life care.
Work is ongoing with vaccination experts, clinicians, Public Health Scotland, GP representative bodies, Data privacy and NHS Boards to finalise the process that will enable those who need an exemption to receive it as quickly as possible while minimising the additional workload for already stretched NHS services including GPs, and in a way that is compatible with the human rights of those who may be entitled to exemption.
The scheme will apply only in the following higher risk settings.
For live events, unseated includes events where some audience members are seated and some standing.Attendees means the number of people attending the event. For multi-day events or events with different time slots it is the number of people attending on any day or time slot. It does not include staff, contractors, performers or volunteers involved in the delivery of the event.
The scheme will be kept under regular review, with three weekly Parliamentary reviews. Any proposed changes to the settings of venues in which certification would apply will be brought back to Parliament for approval.
Nightclubs were not previously defined in the COVID-19 regulations, so the dictionary definition applied. However, there is now a need to define nightclubs and other analogous venues, as behaviours that were previously prohibited are now allowed in wider parts of hospitality (for example, after midnight alcohol, loud music, dancing, and close contact for long periods). We are working with stakeholders to finalise a definition that will ensure the intended public health benefit, but not result in market distortion or displacement.
We havebeen clear that certification will not be a requirement for public services or other settings that people have no option but to attend, such as retail. There will also be exceptions for premises being used for certain purposes, including worship, protest and certain business events that individuals are required to attend for work purposes.
The scheme will apply only to people attending the relevant premises/event as customers it will not apply to those working or performing at the premises/event, as they will be working under health and safety guidance and specific mitigations set by their employer.
The detail of the scheme will continue to develop in a way that takes account of the view of businesses in relevant sectors. However, it will broadly work in the following way:
People will be able to access the NHS Scotland COVID-19 Status app. This will include a persons vaccination record in line with the requirements for international travel. The App screen shows a QR code for each vaccination.
As is currently the case people unable to use the app will be able to request a secure un-editable paper record of vaccination, with enhanced security features such as thermodynamic ink to prevent forgery. This will also have a QR code.
The staff at a venue subject to the scheme will download a free QR code verifier app to a smartphone or device. This will be available for download in week beginning 13 September. Detailed guidance is being developed for venues on how to use this verifier app, and the guidance will have accompanying privacy notices. The guidance will be developed in consultation with relevant venues/businesses. There will also be options for venues to integrate the verifier functionality into their own systems as the source code is open source.
Venue staff check will check a customers QR code to ensure the record of vaccination is genuine.
As indicated earlier, there will also be a process to allow a person who cannot be vaccinated for medical reasons to show a document confirming that they are exempt.
Under 18s will be exempt. As with other, already existing age based entry conditions, a venue might ask for proof of age.
We are working with other UK jurisdictions to ensure interoperability across the UK as well as considering how evidence of vaccination for people from outwith the UK can be verified.
During the course of October, the App will receive an update that will add in additional functions for domestic certification. In practice, this means that the app will have 2 sections one for international travel which will contain the 2D barcodes currently in use which have been designed to meet international travel requirements - and which will be useable for domestic settings from 1 October - and one specifically for domestic settings which will contain a single 2D barcode, confirming an individuals COVID-19 status as valid.
Mandatory vaccine certification will be introduced in regulations under the Coronavirus Act 2020 and supported by guidance. Relevant impact assessments, including an EQIA and BRIA, will be published.
Ministers must review the regulations at least every three weeks to assess whether any requirement in the regulations is still necessary to prevent, protect against, control or provide a public health response to the incidence or spread of infection in Scotland with coronavirus. As soon as Ministers consider the requirements to no longer be necessary for this purpose, they must be revoked.
We propose that the regulations will be drafted to impose a legal obligation on the person responsible for operating the business or venue to take all reasonable measures to restrict entry only to those fully vaccinated (unless exempt). We are also considering whether there is a need for offences with regard to the misuse of certificates by individuals.
We will publish guidance to help set out what reasonable measures would be proportionate in different settings (for example, what is proportionate on entry to a nightclub of 200 people may not be proportionate or possible in an event crowd of 60,000).
We are working closely and at pace with sectors to finalise a proportionate, effective and robust scheme for each setting before implementation. There are a number of operational and logistical issues which we are working through together. The sector-specific detail will be published in advance implementation.
All software, apps and paper copies of certificates will be free to use.
Businesses will be able to use an app free of charge to scan the codes used on all certificates. Businesses will require a hardware mechanism (such as mobile phones) to verify the certificates. Any additional staffing or infrastructure costs will be met by businesses. While we do not underestimate challenges for businesses, it is important to recognise that vaccine certification is intended to be a proportionate alternative to the risk of further periods of closure for higher risk venues.
Security of the COVID-19 certificates generated is critical. Security features on the App will include a process for user identification using suitable photographic ID, and user email verification. The certificates generated digitally on the App cannot be altered or changed.
The security of all COVID-19 certificates is aligned to the same standards used across the other 4 Nations for the generation of COVID-19 Certificates.
As part of the security of all certificates, the 2D barcodes (known as QR codes) have an expiry date and these dates are clearly displayed on the PDF downloads and paper copies. Once expired, users will have to request a further update to the certificate, either via the app or paper-based process. Expiry dates are used as part of the overall security of the system, and to help ensure that information is up to date.
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In another blow to the Covidian left, Florida is winning
According to the latest reports, Florida has the lowest Covid-19 levels in the country, and we have to point out that Florida is also one of the freest states in the countrybucking mandates and authoritarian lockdowns entirely.
Meanwhile blue states seem to be struggling
Leftists everywhere are no doubt screaming and crying about thislike they always do about everything that agitates their mental condition.
Freedom wins, freedom always wins, and Florida is a shining example of thatwhich is why I am moving to the state next year.
Leftists can continue to wear 3 masks while they sit indoors attempting to gauge their gender identity on that particular day, but the rest of us are all moving on with our lives, and Florida is leading the charge.
Here are the latest reports:
Fox News reports:
DeSantis has been slammed by critics in the media since the start of the pandemic over his opposition to government-imposed mask and vaccine mandates.
In 2020, DeSantis was accused by a Democratic politician of going on a killing spree for opposing mask mandates and a Vanity Fair headline from September of this year referred to the governor as an angel of death.
At the same time Florida reported the lowest amount of new cases in the country per capita, coronavirus cases are surging in many states where strict lockdown orders were issued by Democratic governors.
Daily Mail had more details:
On Friday, the Sunshine State reported 1,393 new cases of COVID-19, roughly six cases per every 100,000 residents. The state also reported just one death in the past week.
By contrast, Michigan leads the nation in daily coronavirus cases per capita with a 7-day rolling average of 560 per 100,000 residents despite Democratic Gov. Gretchen Whitmer imposing some of the harshest restrictions in the nation.
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Florida Reports The Lowest Daily Corona Virus Cases In The ...
Aerial view taken on Oct. 29, 2021, shows parked plane on the tarmac at Schiphol airport, near Amsterdam.
Arthur Van Der Kooij | ANP | AFP via Getty Images
Dutch health authorities said on Saturday they had detected 61 Covid-19 cases among people who flew from South Africa on Friday and were now conducting further testing to see whether any are infected with the recently discovered Omicron variant.
The cases were discovered among around 600 passengers who arrived at Amsterdam's Schiphol Airport on two flights on Friday before the Dutch government halted air traffic from southern Africa due to concerns over the variant.
The passengers from the flights were kept separated from other travelers and those that tested positive are being kept in isolation at a hotel near the airport.
A spokesperson for the Dutch health ministry said it would not be known until later Saturday whether any of the passengers are infected with the new variant.
A spokesperson for KLM, the Dutch arm of Air France, said the airline was trying to determine what rules were in place as of Friday morning to prevent people with Covid-19 infections from boarding the flights, which departed from Cape Town and Johannesburg.
Rules on the company's website said passengers had to present a negative Covid-19 "rapid antigen" test result taken 24 hours before departure but were not required to show proof of vaccination.
A spokesperson for the health authorities in Kennemerland, the Dutch region that oversees Schiphol, said the positive cases were being analyzed by the National Institute for Health (RIVM).
Passengers on the two KLM flights said they were kept waiting on the tarmac for hours.
"Vigorous applause because there is a BUS that has come to take us ... somewhere," tweeted New York Times journalist Stephanie Nolen, a passenger on the flight from Johannesburg, during the long wait on Friday.
"Bus to a hall to a huge queue. I can see Covid testers in bright blue PPE far on the distance. Still no snacks for the sad babies," she added in a second tweet.
On Saturday, Nolan tweeted that she tested negative and was awaiting a further flight to Canada. Passengers remaining in the Netherlands are required to quarantine at home for 5 days.
The new variant has been detected just as many European countries are grappling with a surge in coronavirus cases.
The Dutch government on Friday announced the nighttime closure of bars, restaurants and most stores as it tries to curb a record-breaking wave of Covid-19 cases that is swamping its healthcare system.
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Dozens of travelers arriving in the Netherlands from South Africa test positive for Covid-19 - CNBC
Travelers walk near an electronic flight notice board displaying canceled flights at O.R. Tambo International Airport in Johannesburg, South Africa, on Saturday. Several countries have begun travel bans in response to the omicron variant. Phill Magakoe/AFP via Getty Images hide caption
Travelers walk near an electronic flight notice board displaying canceled flights at O.R. Tambo International Airport in Johannesburg, South Africa, on Saturday. Several countries have begun travel bans in response to the omicron variant.
At least two people in the United Kingdom have the omicron variant of the coronavirus, the country's health secretary announced.
The cases are linked and involve travel to southern Africa, where the latest variant was first identified, Health Secretary Sajid Javid said Saturday. The individuals are isolating at home.
Cases have also cropped up in Botswana, Belgium, Hong Kong and Israel during a relatively short period of time.
In the U.S., the Centers for Disease Control and Prevention so far has not identified any cases of the fast-spreading omicron strain, which was first detected in South Africa on Nov. 24. The vaccination rate in South Africa is roughly 35%.
The omicron variant is the first new variant of concern since the delta variant that swept through the world earlier this summer, causing an uptick in infections and deaths, particularly among the unvaccinated population. The delta strain was twice as infectious as the original COVID-19 virus.
While there are a number of studies underway to continue evaluating the omicron variant, the World Health Organization says the number of mutations in this variant is "concerning" and that it could suggest an "increased risk of reinfection."
The WHO also says that current COVID-19 tests are capable of identifying this omicron variant, which is how authorities have been able to track how rapidly the variant is spreading. But further information and studies on the variant could take "days to weeks," health officials from WHO said.
Exactly how fast the variant is spreading and whether the current vaccines available can prevent infection are still unclear. But Dr. Francis Collins, director of the National Institutes of Health, told NPR: "Let me be clear, there is no data at the present time to indicate that the current vaccines would not work."
In the meantime, people should continue to take steps to lower their exposure to infection and reduce the spread of the virus, the WHO urges. This includes mask-wearing and getting the vaccine when it's your turn to do so.
Collins also recommends that people who are six months out from being fully vaccinated get their booster shot.
This is a breaking news story. Some things reported by the media may later turn out to be wrong. We will focus on reports from officials and other authorities, credible news outlets and reporters who are at the scene. We will update as the situation develops.
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JOHANNESBURGA fast-spreading new strain of the coronavirus first detected in southern Africa is a global variant of concern and might pose a higher risk of people falling ill with Covid-19 for a second time, the World Health Organization said Friday, as governments around the globe restricted travel from the region.
WHO said there was also preliminary evidence that the variant, which it named Omicron after the Greek letter, was more transmissible than the Delta variant that is currently dominant world-wide, and other virus strains. Health authorities in Belgium, Israel, Hong Kong and Botswana said they had detected first cases of the variant.
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Omicron Identified as Covid-19 Variant of Concern, Triggering Global Fears - The Wall Street Journal
Scientific experts at the World Health Organization warned on Friday that a new coronavirus variant discovered in southern Africa was a variant of concern, the most serious category the agency uses for such tracking.
The designation, announced after an emergency meeting of the health body, is reserved for dangerous variants that may spread quickly, cause severe disease or decrease the effectiveness of vaccines or treatments. The last coronavirus variant to receive this label was Delta, which took off this summer and now accounts for virtually all Covid cases in the United States.
The W.H.O. said the new version, named Omicron, carries a number of genetic mutations that may allow it to spread quickly, perhaps even among the vaccinated.
Independent scientists agreed that Omicron warranted urgent attention, but also pointed out that it would take more research to determine the extent of the threat. Although some variants of concern, like Delta, have lived up to initial worries, others have had a limited impact.
Epidemiologists are trying to say, Easy, tiger, said William Hanage, an epidemiologist at the Harvard T.H. Chan School of Public Health. This could be bad. This could be very bad. But we dont know enough to roll that tape forward.
Dr. Hanage and other researchers said that vaccines will most likely protect against Omicron, but further studies are needed to determine how much of the shots effectiveness may be reduced.
As the coronavirus replicates inside people, new mutations constantly arise. Most provide the virus with no new advantage. When worrisome mutations do emerge, the World Health Organization uses Greek letters to name the variants. The first variant of concern, Alpha, appeared in Britain in late 2020, soon followed by Beta in South Africa.
Omicron first came to light in Botswana, where researchers at the Botswana Harvard H.I.V. Reference Laboratory in Gaborone sequenced the genes of coronaviruses from positive test samples. They found some samples sharing about 50 mutations not found in such a combination before. So far, six people have tested positive for Omicron in Botswana, according to an international database of variants.
Around the same time, researchers in South Africa stumbled across Omicron in a cluster of cases in the province of Gauteng. As of Friday, they have listed 58 Omicron samples on the variant database. But at a news conference on Thursday, Tulio de Oliveira, the director of the Centre for Epidemic Response & Innovation in South Africa, said that close to two or three hundred genetic sequences of Omicron cases would be released in the next few days.
The W.H.O. called for increased surveillance of the variant and laboratory experiments to better understand its biology.
This variant did surprise us, Dr. de Oliveira said at the news conference. But the full significance is still uncertain.
Dr. de Oliveira and his colleagues asked the W.H.O. to hold an emergency meeting about the variant on Friday for two reasons: the mutations in Omicron and what appears to be an alarming spread in South Africa.
The researchers found more than 30 mutations on a protein, called spike, on the surface of the coronavirus. The spike protein is the chief target of antibodies that the immune system produces to fight a Covid-19 infection. So many mutations raised concerns that Omicrons spike might be able to evade antibodies produced by either a previous infection or a vaccine.
Dr. de Oliveira and his colleagues determined a quick way to gauge how quickly Omicron was spreading in South Africa. Although sequencing the entire genome of a virus is slow, the scientists figured out how to identify Omicron with a standard nasal swab test known as P.C.R.
Nov. 27, 2021, 11:51 a.m. ET
The tests are fast because they look for just two of the coronaviruss 29 genes the spike gene and another gene called nucleocapsid. Thanks to its new mutations, Omicron does not test positive for the spike gene. So researchers could simply look for samples that tested positive for nucleocapsid, but negative for spike.
It turned out that spike-negative samples were surging across South Africa, suggesting that Omicron had a competitive advantage over Delta, which until now had been the dominant variant in the country.
It gives us concern that this variant may already be circulating quite widely in the country, Richard Lessells, an infectious disease specialist at the University of KwaZulu-Natal in Durban, South Africa, said at Thursdays news conference.
Dr. de Oliveira warned that South Africa, where less than one-quarter of the population is fully vaccinated, could see a surge of hospitalizations unless the country prevented Omicron from multiplying further in superspreading events. We really would like to be wrong on some of these predictions, he said.
Countries in Europe as well as the United States and Canada have been among those banning flights arriving from South Africa and several other African nations. But Omicron has already been spotted in Hong Kong and Belgium, and may well be in other countries outside of Africa as well.
Theodora Hatziioannou, a virologist at Rockefeller University in New York, said that Omicrons distinctive mutations raise the possibility that it first evolved inside the body of someone with H.I.V., whose immune systems may have been too weak to quickly fight it off. Your responses are just not as good, Dr. Hatziioannou said.
Instead of getting cleared away in a matter of days, the virus may have lingered in that person for months, spending the time gaining the ability to evade antibodies. This virus has seen a lot of antibodies, Dr. Hatziioannou said.
Dr. Hatziioannou and her colleagues have been able to produce mutant spike proteins in their laboratory that make viruses highly resistant to Covid-19 antibodies. She said that Omicron has many mutations in the same regions of the spike protein pinpointed in their own research. The overlap is pretty striking, she said.
That overlap has Dr. Hatziioannou concerned that Omicron will be able to evade some of the antibodies that people have acquired either from vaccines or from Covid-19 infections. Some monoclonal antibody treatments wont work against Omicron either, she predicted, because the variants spike protein is protected from them.
Still, vaccines are expected to provide some protection against Omicron because they stimulate not only antibodies but immune cells that can attack infected cells, Dr. Hatziioannou said. Mutations to the spike protein do not blunt that immune-cell response.
And booster shots could potentially broaden the range of antibodies people make, enabling them to fight against new variants like Omicron. We will see, because these studies are only now ongoing, she said.
For now, theres no evidence that Omicron causes more severe disease than previous variants. And its also not clear yet how quickly Omicron can spread from person to person.
Some earlier variants, such as Beta and Mu, had evolved a strong ability to evade immune defenses. But they never became a serious threat to the world because they proved to be poor at transmitting.
Some mutations in Omicron suggest that it may indeed transmit well. Three mutations alter a region of the spike protein called the furin cleavage site, which is already known to help the spike protein attach more effectively to cells.
But Dr. Hanage said he was not yet convinced by the South African data that Omicron was running rampant across the country. I think its too early to be definitive, he said.
He found it hard to see how a variant could sweep so quickly across South Africa, even while the overall rate of daily new infections in the country remains very low. He speculated that early tests might have been hampered by some technical flaw that could be uncovered in the next few days. It feels to me like part of the puzzle is missing, he said.
It might turn out that the apparent spread of Omicron was actually just a coincidence, as has been seen with some previous variants. If a new variant happens to get swept along during a surge of cases, it will look highly contagious when it isnt.
Even so, Dr. Hanage considered a travel lockdown to be a prudent measure that could buy governments a little time to make plans for dealing with Omicron if it lives up to the worst predictions. Health leaders could use the delay to put in stronger measures for preventing transmission or boosting vaccinations, for example. But just doing it and then thinking itll be enough is not a long-term plan, he said.
Even if Omicron does prove more transmissible than other variants, Dr. Hanage said that vaccines would most likely remain vital weapons against it, both by slowing down its spread and making it more likely that people who do get sick only have mild Covid-19 instead of needing to go to the hospital.
Omicron is certainly enough to take seriously, but its not apocalyptic, Dr. Hanage said. Its not a magic virus. Magic viruses are not a thing.
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New 'Omicron' Variant Stokes Concern but Vaccines May Still Work - The New York Times
Devi Sridhar, professor of global public health at Edinburgh University, has been speaking again to Sky News following the news conference.
Asked if she felt the PM had gone far enough, she said "we don't have enough information" yet about Omicron.
She added that "people shouldn't be too anxious" at this stage because we don't know if the new variant can "out-compete" the dominant Delta strain.
Like Sir Patrick Vallance, she says we have vaccines, boosters, rapid testing and we understand more - so we are in a better position than last winter.
She says mask wearing is a "great" measure to stop infection. Mr Johnson announced the rules on masks would be tightened - though it was his tweet during the news conference that explicitly said they would be compulsory in shops and on public transport.
Professor Sridhar suggests the PM, who has been criticised in recent months for appearing maskless in a hospital and lowering his mask during a theatre performance of Macbeth, should set a better example by masking up while out and about.
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The rocker, who is also a photographer, shared on his verified Instagram account that he had tested positive after arriving at Milan Malpensa airport.
"Here I am, just arrived in Milano, and I've tested positive for the second time in a month for Covid," the caption read next to photos of him at the airport. "So it's off to the hospital for me. Thanks for all your support #sohappyithurts."
In October, Adams had to pull out of a performance at the Rock and Roll Hall of Fame Induction Ceremony after he tested positive.
Dr. Anthony Fauci told CNN's "New Day" on Friday that while he didn't want to speculate on Adams' case, "It could be that he continued to have virus in him and that he tested positive and never really got rid of the virus in his system."
"We find that when some people who are immune-compromised that they can have virus lingering on," Fauci said. "I know nothing about his medical condition so I'm really very reluctant to make any comment about it."
That version of the famed calendar includes images of several stars including Cher, Iggy Pop, Jennifer Hudson and Normani.
CNN has reached out to reps for Adams for comment.
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Bryan Adams tests positive for Covid-19 for the second time - CNN
For Immediate Release: November 19, 2021
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Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. The Centers for Disease Control and Preventions (CDC) Advisory Committee on Immunization Practices will meet later today to discuss further clinical recommendations.
Throughout the course of the COVID-19 pandemic, the FDA has worked to make timely public health decisions as the pandemic evolves. COVID-19 vaccines have proven to be the best and highly effective defense against COVID-19. Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death, said Acting FDA Commissioner Janet Woodcock, M.D.
Prior to todays authorizations, a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines was authorized for administration to individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19 and individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2. Todays action expands the use of booster doses of both vaccines to include all individuals 18 years of age and older at least six months after completion of the primary vaccination series of the Moderna COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine or at least two months after completion of primary vaccination with the Janssen COVID-19 Vaccine.
The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older, said Peter Marks, M.D., Ph.D., director of the FDAs Center for Biologics Evaluation and Research. Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one.
Data Supporting Effectiveness
The EUA for a single booster dose for individuals 18 years of age and older for the Moderna (administered as half of the dose of a primary series dose) and Pfizer-BioNTech COVID-19 vaccines is based on the FDAs analysis of immune response data that supported use in the previously authorized populations for boosters.
For the Moderna COVID-19 Vaccine booster dose, the FDA analyzed the immune response data from 149 participants 18 years of age and older from the original clinical studies who received a booster dose at least six months after their second dose and compared it to the immune responses of 1,055 study participants after completing their two-dose series. The antibody response against the SARS-CoV-2 virus 29 days after a booster dose of the vaccine demonstrated a booster response.
For the Pfizer-BioNTech COVID-19 Vaccine booster dose, the FDA analyzed the immune response data from approximately 200 participants 18 through 55 years of age who received a single booster dose about six months after their second dose. The antibody response against the SARS-CoV-2 virus one month after a booster dose of the vaccine when compared to the response one month after the two-dose primary series in the same individuals demonstrated a booster response.
FDA Evaluation of Benefits and Risks
Since Moderna and Pfizer-BioNTech initially submitted safety and effectiveness data on a single booster dose following primary vaccination to the FDA, additional real-world data have become available on the recently increasing number of cases of COVID-19 in the U.S. and on the risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) following vaccination with these vaccines. These additional data enabled the FDA to reassess the benefits and risks of the use of these vaccines in the general adult population. The FDA has determined that the benefits of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccines outweigh the risks of myocarditis and pericarditis in individuals age 18 years of age and older when used following completion of primary vaccination to provide continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death.
Both Pfizer and Moderna are conducting post-authorization/post-marketing studies to assess known serious risks of myocarditis and pericarditis. In addition, the FDA and the CDC have several systems in place to continually monitor COVID-19 vaccine safety and allow for the rapid detection and investigation of potential safety concerns.
The fact sheets for both vaccines for recipients and caregivers and for healthcare providers contain information about the potential side effects, including the risk of myocarditis and pericarditis. The most commonly reported side effects by individuals who received a booster dose of the vaccines were pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain and chills. Of note, swollen lymph nodes in the underarm were observed more frequently following the booster dose than after the primary two-dose series.
The FDA did not hold a meeting of the Vaccines and Related Biological Products Advisory Committee on these actions as the agency previously convened the committee for extensive discussions regarding the use of booster doses of COVID-19 vaccines and, after review of both Pfizers and Modernas EUA requests, the FDA concluded that the requests do not raise questions that would benefit from additional discussion by committee members.
The amendments to the EUAs were granted to ModernaTX Inc. and 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.
11/19/2021
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Coronavirus (COVID-19) Update: FDA Expands Eligibility for COVID-19 Vaccine Boosters | FDA - FDA.gov
