USA – People above 65 years and adults at high risk of severe COVID-19 infection are now eligible to receive Pfizer/BioNTech’s booster dose vaccine, following emergency use authorization by the Food and Drug Administration (FDA).
The decision paves the way for millions of people who received their second dose of the vaccine at least six months ago to receive booster shots as soon as they can.
This emergency use authorization was based on the totality of scientific evidence shared by the companies and reviewed by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), which included data from the Pfizer-BioNTech clinical program evaluating the efficacy and safety of a booster dose of the vaccine.
Experts believe boosters have a significant role in counteracting the pandemic’s threat, alongside the concerted efforts to increase global access and uptake among the unvaccinated populations.
Some countries, including Israel and the United Kingdom, have already launched COVID-19 booster-shot awareness campaigns. According to CDC data, the United States authorized extra shots for people with compromised immune systems, and over 2 million people have already received the third shot.
The emergency use authorization is supported by clinical data underlining that a booster vaccination induces more robust immunogenicity against tested variants of the virus; thus, it is suitable for addressing current health needs.
“This first FDA authorization of a COVID-19 vaccine booster is a critical milestone in the ongoing fight against this disease,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.
Declining vaccine efficacy
The FDA said it approved the booster in part because of a Pfizer study that found people who received the vaccine earlier in a clinical trial had a “modest decrease in efficacy” in July and August compared to those who received the vaccines later.
The Centers for Disease Control and Prevention reported that the level of protection against Covid hospitalizations provided by the Pfizer-BioNTech SE vaccine dropped significantly four months after complete inoculation, hours before the FDA approval.
The new study discovered that the Pfizer vaccine was 91% effective in preventing hospitalization two weeks after recipients received their second dose — a point at which they are typically considered fully vaccinated — to four months later. However, after 120 days, its effectiveness dropped to 77%.
FDA’s action is a positive milestone in helping the most vulnerable populations to remain protected from COVID-19.