FDA Set to Approve Third COVID-19 Booster Shot For Cancer Patients and the Immunocompromised

The person said that it was not yet clear if this would apply to any individual who has had cancer or just those who are currently receiving treatment for the disease. The same goes for transplant patients.

NBC was the first to report the news.

The FDA has timed the announcement to come one day before the Centers for Disease Control Advisory Committee on Immunization Practices  holds its monthly meeting, at which point there is expected to be further information about the rollout and availability of these vaccines.

A majority of that group’s members voiced their approval for a booster during their last meeting in July, but refused to vote on the matter or issue a formal recommendation at that time.

Two studies published on Wednesday revealed that cancer patients who are receiving treatment as well as those who are in remission or have yet to be treated for the disease developed significantly less COVID antibodies after receiving vaccinations than Americans who are not immunocomprimised.

Top oncologists told SurvivorNet in early July that COVID-19 booster shots would be a benefit for immunocompromised people, including cancer patients.

Soon after, Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases, said during a White House briefing that it is “extremely important for us to move to get those individuals their boosters and we are now working on that.” He said that many immunosuppressed people did not have a response to the vaccine "that we feel would be adequately protective."

Dr. John N. Greene, chief of infectious diseases at the Moffitt Cancer Center in Tampa, explained the benefits of a third dose for those who are immunocompromised.

"Some medical centers have looked at giving a booster vaccine dose, a third dose, and they found that some of these [cancer] patients now have a high enough immune response to potentially prevent infection," Dr. Green said in an earlier interview. "But we don't know how long-lasting even those are, but at least the numbers are high enough that it could prevent an infection. So if you would give a booster vaccine or you could get a higher immune response quantitatively, then those patients could actually do fine even if exposed to the Delta variant. And that's been true with other variants as well. They believe that the higher the titers you can maintain, the greater the chance you can prevent infection."

Colorectal surgeon and SurvivorNet advisor Dr. Heather Yeo thinks boosters are the next obvious step.

“The CDC is considering a booster now, they haven't made a definitive timeline.  I do think we will need boosters soon, particularly for those with less robust immune responses, hopefully the CDC will issue guidance soon,” Dr. Yeo said in a previous interview. “For now, making sure to encourage others to get vaccinated and to wear proper personal protective equipment (PPE) is important.”

According to July CDC data, immunocompromised individuals represent 44% of COVID breakthrough cases requiring hospitalization, despite representing less than 3% of the population.

That population is also more likely to experience severe symptoms of COVID-19, are at a higher risk of transmitting the virus to family and friends,  and are more susceptible to testing positive for the highly-contagious Delta variant even after they have been fully vaccinated.

Those were just a few of the concerning facts and statistics that were shared at a July meeting of the Centers for Disease Control’s Advisory Committee on Immunization Practices, which ended with the group stating that they lacked the power to approve a third booster shot for this high-risk population.

The advisory panel cannot recommend additional shots for anyone until the Food and Drug Administration grants full approval of the Covid vaccines or amends the emergency use authorizations.

A member of the CDC’s advisory group says that some immunocompromised people are finding third doses on their own.

“I am concerned about [immunocompromised patients getting a booster] in an unsupervised fashion, but as of right now it is due to regulatory issues,” the board member said. “We are not allowed to recommend additional doses to any patients so they are really just doing what they think is best.”

The World Health Organization on Wednesday called for a halt on boosters, citing an increasing gap in vaccination availability between poor and rich countries.

“I understand the concern of all governments to protect their people from the Delta variant. But we cannot accept countries that have already used most of the global supply of vaccines using even more of it,” WHO head Tedros Adhanom Ghebreyesus said.

Meanwhile, Israel is offering booster shots to citizens over the age of 60. Germany and France plan to offer boosters to elderly and immunocompromised people starting in September.

Contributing: Chris Spargo, Alison Maxwell

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