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FDA authorizes COVID-19 booster shots for the immunocompromised

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WHAT YOU NEED TO KNOW:


  • The USFDA authorizes the use of Covid vaccine boosters for people with weakened immune systems.
  • The authorization comes amid the surge of new Covid cases fueled by the highly transmissible delta variant.
  • Immunocompromised people do not produce an adequate immune response even after getting two doses of a vaccine.

Immunocompromised Americans will be able to get a third shot of either of the mRNA vaccines, Pfizer or Moderna, the U.S. Food and Drug Administration announced late Thursday.

The booster will be targeted specifically for people who did not have an ideal immune response to their initial vaccines, which has proven to be the case for many cancer patients, transplant recipients, people with HIV and people on immunosuppressant drugs.

Acknowledging that the US is now facing another wave of the COVID-19 pandemic, acting FDA Commissioner Janet Woodcock said that “immunocompromised people are particularly at risk for severe disease.”

In a statement, Woodcock said, “After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines.”

The FDA has not yet authorized a booster shot for the general population. Woodcock explained that other fully vaccinated individuals “are adequately protected and do not need an additional dose of COVID-19 vaccine at this time.”

The number of people who will be eligible for the booster shots “encompasses a relatively small proportion of the population, around 3% or so of people would fall into that category,” Dr. Anthony Fauci said in an interview on ABC’s “Good Morning America” Thursday.

Some immunocompromised people even had no immune response to the vaccines— a disappointment considering the high risk they have for getting severely ill from the virus.

In one U.S. study, 44% of hospitalized breakthrough cases were immunocompromised people. An Israeli study found it was around 40%.

But CDC data shows that a third dose could boost antibodies in an immunocompromised person by up to 50%.

The CDC panel is expected to vote to recommend the third dose when it meets Friday at 11 a.m. and CDC Director Rochelle Walensky will likely sign off after a Friday afternoon vote.

Experts clarified that this third shot for immunocompromised people is separate from booster shots for the general public, which people are expected to need as the protection from the vaccines wanes over time. But the CDC, which is monitoring immunity in multiple groups of people across the country, said the U.S. isn’t there yet.

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“If and when it does — and it’s likely that it will because no vaccine is going to last forever — we’re going to be ready and have a plan to be able to give those individuals the additional dose that they might need,” Fauci said Thursday.

Source: MSN

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