FDA Approves Second Booster For Older Adults, Some Immunocompromised People

On Tuesday, the U.S. Food and Drug Administration (FDA) authorized a second booster shot for adults 50 years of age and up for the Pfizer and Moderna COVID-19 vaccines, and for specific immunocompromised people in certain ways.

The FDA stated: 

A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.

A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered to individuals 12 years of age and older with certain kinds of immunocompromise at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. These are people who have undergone solid organ transplantation, or who are living with conditions that are considered to have an equivalent level of immunocompromise.

A second booster dose of the Moderna COVID-19 Vaccine may be administered at least 4 months after the first booster dose of any authorized or approved COVID-19 vaccine to individuals 18 years of age and older with the same certain kinds of immunocompromise. 

“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals. Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said. 

“Additionally, the data show that an initial booster dose is critical in helping to protect all adults from the potentially severe outcomes of COVID-19. So, those who have not received their initial booster dose are strongly encouraged to do so,” Marks added. 

The New York Times reported that the Centers for Disease Control and Prevention (CDC) will likely put forward advice on who should think about getting the dose as early as Tuesday. 

“As of late last week, officials were planning to present the second booster essentially as an option that older Americans or people with underlying medical conditions should consider, rather than recommending it outright,” the outlet noted. 

In a move that could be deemed controversial by many, the approval went around the independent panels of the FDA and CDC, which have given guidance to the agencies over the course of the pandemic. 

NBC News reported, “During a call with reporters, Dr. Peter Marks, the FDA’s top vaccine regulator, said officials didn’t seek the advice of the committees because they believe the risk of harm from an additional shot, including the risk of myocarditis, is low. He said it’s possible Americans may need to get yet another dose of a Covid vaccine this fall.”

“That later dose, Marks said, may not be the same version of the shots currently in use — regulators may transition to a variant-specific vaccine or one that targets more than one strain. Both Pfizer and Moderna are testing a vaccine that targets the omicron variant. Moderna is also testing a shot that targets both the delta and omicron variants,” the outlet added. 

“At some point, we are going to have to realize that this is a virus that’s going to be with us and that we have to come to grips with dealing with it on a regular basis,” he said.

The Wall Street Journal reported that around two-thirds of adults over 65 years of age have gotten a booster shot thus far, while fewer than half of adults have. 

The Journal pointed to a recent survey by the Kaiser Family Foundation which showed that around 23% of people who got at least one COVID-19 vaccine shot said they definitely won’t receive a booster. Additionally, 24% said they would only get a booster if they were made to do so. The remainder stated they would get the dose or wait and see. 

As soon as the CDC gives its approval, the boosters will be at doctor offices, pharmacies, nursing home facilities, and other vaccination centers, per The Journal. 

The desire of many Americans to get an additional vaccine dose may be waning even more in recent weeks than it was when the first boosters were approved, especially after the Omicron variant swept through the country.

A new subvariant of Omicron called BA.2 is reportedly spreading across the United States, “now accounting for more than a third of all COVID-19 infections, according to data published by the Centers for Disease Control and Prevention (CDC),” The Daily Wire reported last week. 

However, Dr. Anthony Fauci doesn’t anticipate a massive surge in cases.

“The bottom line is we’ll likely see an uptick in cases, as we’ve seen in the European countries, particularly the U.K.,” Fauci reportedly said on ABC. “Hopefully we won’t see a surge — I don’t think we will.”

The Daily Wire highlighted, “Several studies have found that BA.2 is even more transmissible than an earlier variant, BA.1, but still most scientists are not concerned.”

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