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FDA USA authorizes fourth Pfizer and Moderna Covid vaccine doses

Maghanda na kayo dyan mga bakunado. Baka implement din ang 4th dose dito sa atin. La ata sila balak tantanan ang mga tao hangga't nabubuhay pa.

  • The Food and Drug Administration has authorized a fourth Pfizer and Moderna dose for people age 50 and older.
  • The Centers for Disease Control and Prevention quickly backed the decision, allowing the shots to be administered.
  • The FDA and CDC made the decision without consulting their committees of independent vaccine experts.
  • BA.2 has gained ground in the U.S. since February and is expected to become the dominant variant here in the coming weeks.
The top U.S. health regulators on Tuesday cleared fourth Covid vaccine doses for older adults, amid uncertainty over whether an even more contagious version of omicron will cause another wave of infections in the U.S. as it has in Europe and China.

The FDA authorized Pfizer and Moderna fourth doses for everyone age 50 and older, as well as a fifth dose for certain younger people with compromised immune systems. People age 12 and older with weakened immune systems are eligible for a Pfizer fifth dose, and those 18 and older with the same condition are eligible for Moderna.

The Centers for Disease Control and Prevention quickly signed off on the decision, paving the way for those eligible to get a new round of boosters. The CDC also recommended that all adults who received two doses of Johnson & Johnson’s vaccine get third shots using Pfizer or Moderna. Adults who received the J&J vaccine and a second shot of Pfizer or Moderna are not yet eligible for a third dose, unless they are age 50 and older or have compromised immune systems.

All of the new boosters are to be administered at least four months after the last shot.

The FDA and CDC made the decision without calling meetings of their vaccine advisory committees, a rare move the agencies have made more frequently over the course of the pandemic to expand uses of already-approved Covid vaccines. The drug regulator’s authorization comes just two weeks after Pfizer and Moderna asked the FDA to permit a second booster shot based on data from Israel.

The FDA’s advisory committee on vaccines is scheduled to meet on April 6 to discuss the future of booster shots in the U.S. The vaccine experts are expected to hold a broad discussion about boosters and will not vote on a specific recommendation.

Dr. Peter Marks, head of the FDA office responsible for vaccine safety and efficacy, said the drug regulator did not call an advisory meeting because the decision was “relatively straightforward.”

“This fourth booster dose is something that evidence that we have now from Israel suggests that by getting this, one can reduce the risk of hospitalization and death in this population of older individuals,” Marks said during a call with reporters after the decision.

Dr. Paul Offit, a committee member, criticized the drug regulator for moving forward without holding an open meeting where the American public can hear experts weigh the data and make a recommendation to the FDA about the best path forward. The vaccine advisory committee’s recommendations are nonbinding, but they help provide transparency for the public.

“It’s just sort of fait accompli,” Offit said of the FDA authorization. “So is this the way it works? We talk endlessly about how we follow the science — it doesn’t seem to work out that way.”

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