Pharmaceutical company Pfizer and its German partner BioNTech are expected to seek authorization for their Wuhan coronavirus vaccine booster for adults age 18 and older, The Washington Post reported Monday.
The request, which will reportedly be filed as early as this week, is expected to win the backing of the Food and Drug Administration (FDA). Pfizer spokesman Kit Longley declined to confirm to The Post the company’s plans on seeking approval for boosters.
In August, the White House announced that it was moving forward with a COVID-19 booster shot program for all adults, as Katie reported. Shortly after, as Matt covered, an FDA panel formally rejected the Biden administration’s plan to administer booster shots to the general public. Reportedly, the data suggested that boosters would be good for the elderly, but not all adults. The FDA panel ultimately approved the Pfizer booster for those 65 and older and those who are “high-risk.”
In September, two top FDA officials reportedly resigned over the booster shot process that was “pushed” by the Biden administration and the Centers for Disease Control and Prevention (CDC). The two officials, Dr. Marion Gruber and Dr. Philip Krause, previously took part in approving vaccines at the FDA.
In an article penned by a group of scientists, including Krause and Gruber, they stated that “current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high.” Additionally, the article stated “[t]his is a compelling issue, particularly as the currently available evidence does not show the need for widespread use of booster vaccination in populations that have received an effective primary vaccination regimen.”
Last month, the Food and Drug Administration (FDA) announced that it would allow mix-and-match COVID-19 booster shots for eligible adults. Last week, the Centers for Disease Control and Prevention (CDC) signed off on a recommendation that a lower-dosage Pfizer-BioNTech vaccine can be used on children ages 5 to 11. This came after the FDA approved Emergency Use Authorization (EUA) for children ages 5 to 11 on Oct. 29.