The FDA allows certain immunocompromised people to receive an additional Covid-19 vaccine

The FDA has amended the emergency use authorization for the Pfizer / BioNTech and Moderna Covid-19 vaccines to allow certain people with a weakened immune system to receive additional doses. The group includes “specifically, solid organ transplant recipients, or recipients diagnosed with a condition suspected of having an equivalent level of immunodeficiency,” the agency said in a statement Thursday.

“The country is entering yet another wave of the COVID-19 pandemic, and the FDA is particularly aware that immunocompromised people are at risk of particularly serious illness,” said FDA Commissioner. Dr. Janet Woodcock said in a statement. “After a thorough review of the available data, the FDA has determined that this small and vulnerable group may benefit from a third dose of Pfizer-BioNTech or Moderna vaccine.”

Currently, three coronavirus vaccines are licensed for emergency use in the United States. Two doses of Pfizer / BioNTech vaccine for people over 12 years old, two doses of Moderna vaccine and one dose of Johnson & Johnson vaccine for people over 18 years old.

All three are used under an emergency use authorization by the FDA, Full approval of Pfizer vaccine pending..

The CDC Advisory Board on Immunodeficiency Practices will meet on Friday to discuss boosters of the Covid-19 vaccine and boosters for some immunocompromised people. Meeting agenda posted online.. The Commission will also vote Friday on whether to recommend additional vaccines to people with immunodeficiency.

According to a recent study by Johns Hopkins researchers, people vaccinated against immunodeficiency will eventually be hospitalized or die of Covid-19 compared to the vaccinated general population. It turns out that the chances are 485 times higher.

The CDC estimates that about 9 million Americans are immunocompromised due to illness or any of the medications they are taking.

“New data show that certain people with weakened immunity, such as those who have had an organ transplant or some cancer patients, do not get a sufficient immune response with just two Covid vaccines. It may have happened, “said CDC Director Dr. Rochelle Walensky. Said during a briefing on the White House Covid-19 response team on Thursday. “Obviously, this is a very small population. We estimate it to be less than 3% of adults.”

It has been known for months that the Covid-19 vaccine may not work well in this group. The overall vaccination rate was very high and it was expected that “herds” would protect them. However, it didn’t work that way because about one-third of eligible people in the United States had never been vaccinated with the Covid-19 vaccine.

The FDA also recommends that people with immunodeficiency maintain other precautions, including physical distance and masking.

“In addition, close contact with immunocompromised people should be vaccinated to increase protection for their loved ones, depending on their health,” according to a statement by the FDA on Thursday.

In addition, the FDA recommends that people with immunodeficiency who are infected or exposed to Covid-19 check with their doctor about monoclonal antibody treatment.

“Inevitably, there will be times when we have to give a boost.”

Even in healthy people, some researchers and health officials may not be able to protect against coronavirus variants as the body-induced vaccine declines over time (perhaps more than a year later). He states that he suspects immunity to Covid-19. It has the potential to emerge and evolve.

This means that vaccinated people may need booster doses of vaccine to remain protected from the original coronavirus strain and emerging variants. It’s a bit like the way tetanus boosters are recommended every 10 years and the way different flu vaccines are recommended each year.

However, for the general public, health officials say they are closely monitoring the data to determine when a third dose deployment may be needed more extensively.

“The important thing to point out is the difference in weakened immunity. They didn’t get a good response from the beginning because of weakened immunity, so I think they got it first. It’s important to reach what you were doing. Your immune system is weakened, so your immune system isn’t weakened. This is different from the persistence of the reaction, “said the director of the National Institutes of Health. One Dr. Anthony Fauci said. Told NBC Craig Melvin At the Thursday show.

“At least vaccines that don’t fall into this category will not be protected indefinitely,” Forch said.

“Inevitably, there are times when we have to boost. What we literally do weekly and monthly is to track the patient cohort and get it, when and who gets it. It’s about deciding what to do. We’re not going to give people boosters, except that their immunity is weakened. ” “But we follow them very carefully and if they need it, we are ready to give it to them.”

The Biden administration Covid-19 Vaccine Booster Strategy For all Americans vaccinated in September.

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