The mission to deliver booster shots of the COVID-19 vaccine to all willing Americans came to a halt on Friday when the US Food and Drug Administration (FDA) voted to only approve the emergency use authorization (EUA) of the Pfizer shot to people age 65 and older and those at a high risk of developing a severe case of the virus.
The decision was made by vaccine advisers to the FDA after hearing hours of research regarding the efficacy of the immunization and what the third booster shot will provide. The Vaccines and Related Biological Products Advisory Committee of the FDA voted to reject the application of the boosters for everyone over the age of 16 six months after they were fully vaccinated.
The committee advisers include various public health experts, immunologists, pediatricians, and specialists in the field of infectious diseases. The group of experts was unanimous in their decision to authorize the use of boosters for high-risk individuals and those over the age of 65. They also included healthcare workers in this EUA.
It should be noted that immunocompromised individuals received the ability to get the third booster during the middle of August. Over two million Americans have already received this third shot.
Blow to Biden Administration
The decision is a blow to the administration of President Joe Biden. Last month, the Biden administration had announced that boosters would be available to all Americans age 16 and older beginning the week of September 20 once they were six months past their second dose. However, the FDA has the final approval on these issues, forcing the Biden team to walk back this availability. Shortly after the August announcement about the booster availability for most Americans, the Biden administration said that it would be pending approval by both the FDA and the US Centers for Disease Control and Prevention (CDC).
Reasons for Rejection of Broader Use
The FDA committee said that they were hesitant to give the EUA to the general population because of a lack of long-term efficacy data regarding the third booster dose. In addition, members of the committee said that they were skeptical about the safety of the third shot for younger adults and teenagers. A handful of members of the committee made it clear during the meeting that they wanted to see more data before signing off on widespread booster doses.
Pfizer’s Rationale
During the meeting, Pfizer attempted to make a strong case for the approval of a booster shot across the broader population. Dr. William Gruber, senior vice president of vaccine clinical research and development at Pfizer, noted various studies that demonstrated that an individual’s immunity will begin to wane over time, necessitating the use of boosters. Gruber also noted that the third shot does not produce additional side effects beyond what was observed after the first two doses.
Pfizer is relying on comprehensive data from Israel, a country that has already begun to administer third doses. Israeli researchers also presented data during the FDA meeting, noting that the use of booster shots in their general population has worked to keep hospitalizations under control.
What is Next?
Now that the FDA advisory committee has made its recommendation, the group as a whole will make the formal decision. The baton will then pass to the CDC. This group has a meeting scheduled for September 22 and 23. The CDC will need to weigh in for final approval for the doses to be available to the designated groups. The CDC is currently urging local and state officials to wait to administer the boosters until they have given the final stamp of approval.
Florida’s Numbers Dropping
In other COVID-19 news, the state of Florida continues to see a sharp decline in new COVID-19 cases. The state reported fewer than 100,000 new confirmed cases of the virus over the last week. This marks the first time since July 16 that Florida was under 100,000 cases for the week.
The state has been seeing declining numbers since August 20 when officials reported 151,880 cases in one week. The positivity rate is now sitting at 11.2% with 384 deaths reported over the last seven days.
While this decline in cases is certainly good news, the state also reported that it surpassed the 50,000-mark in total deaths since the beginning of the pandemic.
New Los Angeles County Restrictions
Beginning on October 7, Los Angeles County will be requiring that customers and employees at indoor bars, wineries, nightclubs, lounges, and breweries provide proof of COVID-19 vaccination. The new health order does not apply to children under the age of 12. Under the rules, customers and employees will need to show proof of at least one dose by October 7 and be fully vaccinated prior to November 4.
This latest health order also mandates vaccine verification or proof of a negative test result within the last 72 hours for people attending large events with over 10,000 attendees. This will apply to venues such as sporting arenas, theme parks, and more.
King County Also Jumps on Board
On Thursday, King County in Washington state also jumped on board the idea of requiring proof of vaccination or a negative test for indoor dining, theaters, gyms, and more. Home to over two million people, King County includes the city of Seattle and many of its most populous suburbs. The rule will go into effect on October 25 in an effort to give residents the time to get fully vaccinated. Like LA County’s restrictions, the rules do not apply to kids under the age of 12.
The King County mandate also applies to outdoor events with over 500 people in attendance, including professional and collegiate sports. It does not apply to high school or youth sporting events.
