COVID-19 booster: This is everything we know so far about the extra dose approved by the FDA

HOUSTON – Transplant recipients and others with severely weakened immune systems can get an extra dose of the Pfizer or Moderna COVID-19 vaccines to better protect them as the delta variant continues to surge across the U.S., federal regulators said Thursday.

RELATED: Extra COVID-19 vaccine OK’d for those with weakened immune systems

Get the official guidance from the FDA.

Who can get it?

U.S. regulators say transplant recipients and others with severely weakened immune systems can get an extra dose of the Pfizer or Moderna COVID-19 vaccines to better protect them as the delta variant continues to surge.

People with organ transplants, certain cancers or other disorders. The FDA’s decision only applies to this high-risk group, estimated to be no more than 3% of U.S. adults.

This is the official language from the FDA: “The authorizations for these vaccines have been amended to allow for an additional, or third, dose to be administered at least 28 days following the two-dose regimen of the same vaccine to individuals 18 years of age or older (ages 12 or older for Pfizer-BioNTech) who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.”

Who else is doing this?

Several other countries, including France and Israel, have similar recommendations.

When can you get it?

The FDA determined that transplant recipients and others with a similar level of compromised immunity can receive a third dose of the vaccines from Pfizer and Moderna at least 28 days after getting their second shot. The FDA made no mention of immune-compromised patients who received the single-dose Johnson & Johnson vaccine.

The Centers for Disease Control and Prevention is expected to formally recommend the extra shots for certain immune-compromised groups after a meeting Friday of its outside advisers.

Will it work?

The Associated Press reports there’s little data on how well a third dose works, and if it causes any safety problems such as an increased risk of organ rejection. Wednesday, Canadian researchers reported that transplant recipients were more likely to have high levels of antibodies if they got a third dose than those given a dummy shot for comparison. Other small studies have similarly found that some transplant recipients respond to a third dose while others still lack enough protection.

Will others be offered the booster?

This booster is not an opening for booster doses for the general population, but U.S. health officials are continuing to closely monitor if and when average people’s immunity wanes enough to require boosters for everyone.

However, some people have been taking a booster without FDA approval. Pfizer has said it plans to seek U.S. Food and Drug Administration approval for booster shots, health authorities say that for now, the fully vaccinated seem well protected.

Yet health care providers in the U.S. have reported more than 900 instances of people getting a third dose of COVID-19 vaccines in a database run by the Centers for Disease Control and Prevention, an Associated Press review of the system’s data found. Because reporting is voluntary, the full extent of people who have received third doses is unknown. It’s also unknown if all of those people were actively trying to get a third dose as a booster.

What questions do you have about the booster? Let us know in the comments and we’ll try to find an answer and include it in this article.


About the Authors:

Amanda Cochran is an Edward R. Murrow award-winning journalist. She specializes in Texas features, consumer and business news and local crime coverage.