FDA approves boosters for immunocompromised people, CDC needs to sign off

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Last month, Pfizer announced that they planned to seek emergency FDA approval for a booster shot of their vaccine, given six months after the last series of their shots. Their studies showed that the third shot was well tolerated and that it provided “neutralization titers… 5 to 10 times higher than after two primary doses.” Many of us welcomed this news because people are getting breakthrough covid cases from the more powerful variants. However the CDC and FDA issued a terse statement responding to Pfizer’s press release in July, stating that “Americans who have been fully vaccinated do not need a booster shot at this time.” The FDA is now recommending that immunocompromised people, including organ transplant recipients and those with cancer and HIV, get booster shots from booth Pfizer and Moderna. We’re still waiting to hear what the CDC says about this because they have the final word.

The Food and Drug Administration authorized Covid-19 vaccine booster shots for people with weakened immune systems, a highly anticipated move intended to shield some of the most vulnerable Americans from the highly contagious delta variant.

“Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19,” acting FDA Commissioner Dr. Janet Woodcock said in a statement.

The agency said organ transplant recipients and people who are similarly immunocompromised can receive a third dose of the Pfizer-BioNTech or Moderna vaccines. The FDA also emphasized that other fully vaccinated people are “adequately protected” and currently do not need an extra dose.

The FDA OK is not the final go-ahead. The Centers for Disease Control and Prevention’s vaccine advisory committee has scheduled a meeting Friday to consider shots for immunocompromised Americans. If they issue a recommendation and it is approved by the CDC, third shots could begin immediately.

White House chief medical advisor Dr. Anthony Fauci said last week that federal health officials were speeding regulatory efforts to clear third doses for such people, including cancer and HIV patients or those who have had organ transplants. He said new data suggested they don’t produce an adequate immune response after receiving two doses of a Covid vaccine.

“Immunocompromised individuals are vulnerable,” Fauci said Thursday. “It is extremely important for us to move to get those individuals their boosters, and we are now working on that, and we will make that be implemented as quickly as possible. … It is a very high priority.”

Such people represent only about 2.7% of the U.S. adult population but make up about 44% of hospitalized Covid breakthrough cases, which is when a fully vaccinated individual becomes infected, according to recent data from a Centers for Disease Control and Prevention advisory group.

[From CNBC]

I would like to see booster shots made available to older people and the general public on a tiered system similar to how the vaccines were originally rolled out. However we have such a surplus in the US that it’s easy for anyone to go to a drug store or community event and get a third vaccination. There’s no central system to check and many people have already gotten boosters. It’s estimated that over 1.1 million Americans have already had a third unauthorized shot. Of course this is unfair to other countries who don’t have access yet. The WHO has called for a moratorium on boosters until the end of September so more countries can get vaccinated, but that’s the situation we’re in.

I’m happy that people who most vulnerable will hopefully be getting booster shots. I truly hope the CDC does the right thing and quickly approves this. I’m still upset that they lifted mask recommendations. That was ridiculous, premature and had deadly consequences. They were catering to the antivaxxers and trying to persuade people to get vaccinated. That didn’t work, but the fact that so many more people are dying and getting seriously ill did. As cases spike and intensive care units are filling up through the US, more than 500,000 people a day are getting vaccinated in the US. I just hope that vaccines are approved for children under 12 soon and that the rest of us can get boosters without sneaking around.


A post shared by Community Health Centers of AR (@chcarkansas)


A post shared by Community Health Centers of AR (@chcarkansas)

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