Based on the recommendations of its vaccine advisory committee, the U.S. Food and Drug Administration granted Pfizer BioNTech an emergency use authorization for the booster dose of the COVID-19 vaccine for certain populations. A single injection will be given six months after completing the initial two-dose course.
The FDA decided on September 22, 2021 not to provide boosters to the general population (at least not yet). This is in response to the Biden administration’s announcement in August that it will launch boosters to all eligible Americans starting in late September. The direct condemnation of the injection. Biden’s pledge has been widely criticized for being ahead of scientific and regulatory procedures.
Instead, the FDA restricts its third dose of Pfizer’s authorization to people 65 years and older, people 18-64 who are at high risk of severe COVID-19 due to previous illnesses, and people who are frequently exposed to coronavirus due to work, such as Medical staff and teachers.
The immunization practice advisory committee of the Centers for Disease Control and Prevention subsequently issued its own strengthening recommendations on September 23, 2021. Its guidelines and the FDA authorize it to be used for people 65 years of age and older and severe COVID-19, but it does not provide booster injections for people who are frequently exposed to occupations. However, in order to re-adjust the recommendations of these two agencies, CDC Director Dr. Rochelle Walensky rejected the CDC Advisory Committee and provided approval for all groups listed under the FDA’s emergency use authorization—including those with increased workplace risk.
Although the information transmitted between agencies is different, the direct effect is that millions of Americans will line up for more protection due to fears that vaccine immunity will weaken. The next few months may continue to evaluate whether COVID-19 boosters should be used more widely among people who are eligible for vaccination, because there are more data available to inform about the safety, demand, and effectiveness of boosters.
Fault line between FDA and CDC
This worrying booster approval process may surprise some people, because in most cases the FDA is solely responsible for drug approval. However, as the agency responsible for administering the public vaccination program in the United States, it needs CDC approval to begin distributing and administering vaccines.
The close intersection of the two agencies in vaccine approval and distribution has recently become the focus of debate among some senior officials. Two senior FDA vaccine leaders resigned in early September 2021. A former FDA leader cited the expanded role of CDC in vaccine evaluations as the main reason for their departure.
When the CDC’s advisory committee excluded high occupational exposure risks as a group that met the enhanced standards, the tension between these agencies was fully manifested, which violated FDA’s recommendations and authorization. The committee voted not to provide boosters for those who are frequently exposed to occupations, mainly because of concerns that the proposal is too broad-it may cause confusion about who counts as “high-risk” workers.
Coupled with the common view, including some public health officials, that the key data used to promote boosters in a wider population is incomplete and easy to interpret, the CDC committee voted 9 to 6 against the application of the third dose People with increased professional risk.
In the end, Walensky decided to stand with the FDA and extend the booster to those who are in regular contact with occupations—such as health care workers and teachers—to align the two agencies. Although it still falls short of the Biden administration’s commitment to provide booster vaccines to all eligible people in the United States, the decision will pave the way for Pfizer to receive millions of third doses in the next few months.
“As the director of the CDC, my job is to recognize where our actions can have the greatest impact. At CDC, our task is to analyze complex and often imperfect data in order to make specific recommendations for optimizing health. In a pandemic , Even if there is uncertainty, we must take the actions that we expect to bring the greatest benefit,” Varensky said in a statement.
It is expected that more guidance on boosters for COVID-19 will be issued for people vaccinated with Moderna and Johnson & Johnson soon.
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