Pfizer/BioNTech Covid-19 vaccine booster shots are now available. CNN reports the “US Centers for Disease Control (CDC) and Prevention Director Dr. Rochelle Walensky diverged from the agency’s independent vaccine advisers to recommend boosters for a broader group of people — those ages 18 to 64 who are at increased risk of Covid-19.”
Pfizer boosters were approved because recent evidence shows that COVID-19 vaccines begin to lose their effectiveness against the SARS-CoV-2 virus.
This puts people, especially high-risk individuals, in danger of “breakthrough” infections. As the magazine Nature reports, “Immunological studies have documented a steady decline of antibody levels among vaccinated individuals. Long-term follow-up of vaccine trial participants has revealed a growing risk of breakthrough infection. And health-care records from countries such as Israel, the United Kingdom and elsewhere all show that COVID-19 vaccines are losing their strength, at least when it comes to keeping a lid on transmissible disease.”
This initiative actually undermines the CDC’s Advisory Committee on Immunization Practices (ACIP) recommendation, whose members “voted 9-6 against recommending boosters for people ages 18 to 64 who were at greater risk because of their occupational or institutional settings, such as health care workers, caregivers for frail or immunocompromised people, people in homeless shelters and people in correctional facilities” according to CNN.
In a public statement, Walensky said, “As CDC Director, it is my job to recognize where our actions can have the greatest impact. At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good,”
However, the newly-approved boosters will not be available to everyone, which contradicts President Joe Biden’s plans to make boosters universally available. Bidens’ plan caused a ripple of resistance to form in the medical community. Dr. Muge Cevik, a physician and infectious disease expert at the University of St. Andrews in Scotland, who also serves as a COVID-19 advisor to the Scottish and U.K. governments,” pushed back with a tweet earlier in September: “I’m truly disappointed. This decision is not justifiable at all looking at this data,“We are going to use up millions of doses to reduce the small risk of mild infections in fully protected [people with] a tiny risk of hospitalisation, while most of the world waits for a first dose.”
Biden’s proposal also rankled some FDA officials, leading to two high-level resignations. As Business Insider reported,” Dr. Marion Gruber, the director of the FDA’s Office of Vaccines Research and Review, and her deputy, Dr. Philip Krause, plan to leave the FDA in October and November.”
However, with official CDC approval now in place, the Pfizer vaccine will now be available for some people, following the Food and Drug Administration’s guidelines that narrow eligibility. Spciacificzlly, shots are approved for the following groups of people, according to the FDA:
- 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 whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.
Acting FDA Commissioner Janet Woodcock, M.D., stated,“Today’s action demonstrates that science and the currently available data continue to guide the FDA’s decision-making for COVID-19 vaccines during this pandemic. After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for a booster dose in certain populations such as health care workers, teachers and daycare staff, grocery workers and those in homeless shelters or prisons, among others.”
The move by the FDA mirrors efforts by Israel. As reported by The Times of Israel, “Israel — the first country to officially offer a third dose — began its COVID booster campaign on August 1, rolling it out to all those over age 60. It then gradually dropped the eligibility age, expanding it last week to anyone 30 and older. As of Sunday, over 1.9 million Israelis had received the third dose.” Israel, which has been very serious about fighting this pandemic, took further steps to provide unfettered access to the boosters by opening up the hours shots are available.
To that end, Israeli Prime Minister Naftali Bennett stated, “Night inoculations allow people who do not want to miss work to get vaccinated without an appointment at unconventional hours. We will continue to make every effort to vaccinate everyone who is willing and able.”
Not everyone is on board with this open approach. Earlier this month, Dr. Cody Meissner of Tufts University argued, “I don’t think a booster dose is going to significantly contribute to controlling the pandemic. And I think it’s important that the main message we transmit is that we’ve got to get everyone two doses.” Moreover, a group of international vaccine experts concluded that the boosters are largely unwarranted, writing, “Even in populations with fairly high vaccination rates, the unvaccinated are still the major drivers of transmission.”
And Dr. Helen Keipp Talbot of Vanderbilt University framed it this way: “We can give boosters to people, but that’s not really the answer to this pandemic. Hospitals are full because people are not vaccinated. We are declining care to people who deserve care because we are full of unvaccinated COVID-positive patients.”
There are also signs of significant internal friction regarding vaccine boosters inside the Biden administration. As originally reported in Politico, “The tension within the administration plus open skepticism from outside experts has fueled finger-pointing and divisions among health agencies. Career scientists, in particular, have been confused and surprised by the process, multiple people involved in the talks said.”
Meanwhile, the reality is that the broadness of the eligibility requirements will likely result in many more people getting the booster than suggested by the CDC. This is because all you will need to do is attest that you are immunocompromised, rather than show valid proof of this medical condition. As a spokesman for the Hy-Veea chain of supermarkets in the Midwestern states that will be offering the booster, pointed out, “According to the CDC, individuals will need to self-attest that they are severely to moderately immunocompromised but do not need to show proof of their condition.”
Meanwhile, look for future approval of both Moderna and Johnson and Johnson’s COVID-19 boosters in the coming weeks by the CDC and FDA.
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