FDA Panel Recommends XBB Variant-Specific Covid Vaccine

Pfizer, Moderna, and Novavax have expressed the need for additional time to produce millions of doses of the COVID-19 vaccine, which will be available in the upcoming fall season.

Dr. Peter Marks, the F.D.A.’s vaccine chief, stated that the ongoing discussion revolves around finding the most effective means to protect individuals during a period of potentially diminishing immunity, as well as preparing for potential virus mutations during the winter.

According to Natalie Thornburg, a vaccine expert at the Centers for Disease Control and Prevention, the United States has witnessed 6.2 million hospitalizations and 1.1 million deaths due to the virus since the start of the pandemic.

Although the situation has improved this year, there are still vulnerable groups, including the unvaccinated, immunocompromised individuals, and those with underlying conditions like diabetes or cardiovascular diseases. Furthermore, individuals aged 65 and above face an even higher risk, which increases with age.

The booster shots offered last fall provided protection against both the Omicron variant and an earlier variant of COVID-19. Approximately 20 percent of adults in the United States, equating to around 53 million individuals, received the booster shot, with higher rates observed among older adults.

Now, with the introduction of a shot targeting specifically the XBB variant, there may be concerns regarding the immunity of newborns and individuals with compromised immune systems against earlier coronavirus variants. However, the World Health Organization has assured that these variants are no longer in circulation, mitigating potential issues.

The F.D.A. is expected to provide an official recommendation to vaccine manufacturers in the near future. The manufacturers will then conduct studies on the new vaccine formulas and submit data to the agency. If approved, the C.D.C. will provide guidance to healthcare providers regarding the appropriate age groups for vaccination.

An F.D.A. spokesman has stated that an updated vaccine is anticipated to be available by late September, provided that the data supports the safety and effectiveness of the vaccines.

It remains uncertain whether the vaccine manufacturers or the F.D.A. will assess the potential effects of administering multiple vaccines in the fall, including flu and respiratory syncytial virus (R.S.V.) vaccines, which are expected to be available for pregnant individuals and older adults. Additionally, the use of an R.S.V. antibody shot to protect infants has been endorsed by agency advisers.

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