The FDA also said it has approved a second booster vaccine, Pfizer, for people 12 and older who have a weakened immune system, and a second Moderna booster for adults 18 and older with a weakened immune system. All new supplements should be given at least four months after the last dose. The FDA made the decision without a meeting of the Vaccine Advisory Committee, a rare move the agency made most frequently during the pandemic to expand the use of already approved Covid vaccines. The drug regulator’s approval comes just two weeks after Pfizer and Moderna asked the FDA to allow a second data-driven booster from Israel. The Centers for Disease Control and Prevention is expected to sign the decision soon. The FDA decision effectively bypasses the Vaccine Advisory Committee, which is scheduled to meet April 6 to discuss the future of booster vaccines in the United States. Dr. Paul Offit, a member of the committee, criticized the drug regulator for proceeding without holding an open meeting where the American public can hear experts weigh the data and make a recommendation to the FDA on the best way forward. The recommendations of the Vaccine Advisory Committee are not binding, but they do help to provide transparency to the public. “It’s just a kind of accomplished event,” Offit said of the FDA mandate. “Well, that’s the way it works? We talk endlessly about how we follow science – it does not seem to work that way.”
CNBC Health & Science
Read CNBC’s latest global coverage of the Covid pandemic: The FDA has not called on board members to recommend boosting doses since last fall, when they voted in favor of a third dose of Pfizer or Moderna for people 65 and older who are at serious risk of Covid. Health experts disagree on whether a fourth dose of the vaccine is needed right now, although the debate is delicate. There is a general consensus that the elderly or people with an immune system may benefit from additional protection. Another booster dose for young, healthy adults is more controversial, as they are less prone to serious illness than Covid. Dr. Peter Hotez, a vaccine specialist at the Baylor College of Medicine in Houston, said some scientists believe the sole purpose of the shots was to keep people out of the hospital. However, Hotez said vaccine policy should also seek to prevent infection and long-term Covid. The effectiveness of the third dose against micron treatment has also diminished over time, he said. The CDC published a study in February showing that the effectiveness of the third dose against emergency visits dropped from 87% to 66% for emergency visits and from 91% to 78% for hospitalizations four months after receiving the vaccine. “This leaves me worried that the amplifiers will not necessarily last as long as we would like,” said Hotez, who strongly supports a fourth dose based on Israeli data showing that another amplifier increases protection for people over 60. Israeli scientists, in a study published last week, found that the mortality rate from the micron was 78% lower in those aged 60 to 100 who took a fourth dose of Pfizer compared to those who received just three shots. The study, which has not been peer-reviewed, looked at the medical records of more than 500,000 people from January to February at Clalit Health Services, Israel’s largest healthcare provider. The FDA decision to approve the fourth installments for people aged 50 and over was broader than Pfizer’s request and narrower than Moderna. Pfizer had asked the FDA to cancel the fourth installment for people aged 65 and over, while Moderna had asked the drug regulator to allow it for all adults aged 18 and over. Moderna CEO Stephane Bancel told CNBC last week that the biotechnology company submitted a broader request to give the FDA the flexibility to decide which age group needs a fourth installment right now. John Moore, a professor of microbiology and immunology at Weill Cornell Medical College, criticized Moderna’s request for a fourth dose for all adults as an aggressive, general application that does not distinguish between the different needs of older and younger people. “The elderly and weak are in much more need of an extra dose of vaccine than a young healthy athlete,” Moore said. The approval of the fourth shot comes as a more contagious Omicron variant, BA.2, has sparked new waves of infection in major European countries and China, which is battling its worst outbreak since 2020. BA.2 has gained ground in the US from February and is expected to become the dominant variant here in the coming weeks. The chief medical adviser of the White House Dr. Anthony Fauci said infections could rise in the US due to BA.2, although he did not expect another wave. BA.2 generally does not make people sicker than the previous version of omicron, BA.1, and vaccines have the same level of effectiveness against both types of variant, according to studies from South Africa and Qatar, among others. . No studies have been evaluated by peers. It is unclear whether the FDA will approve fourth installments for younger adults at some point, as there is less data to support such a decision at this time. An Israeli study in February among health workers aged 18 and over showed that a fourth dose does not boost immunity, but restores it to the maximum strength of the third dose. Many people in the fourth dose study were still infected, even though they were either asymptomatic or had mild symptoms. “A fourth vaccination of healthy young workers can have only marginal benefits,” Dr Gili Regev-Yochay and a team of scientists from Sheba Medical Center and the Israeli Ministry of Health wrote in a letter to New England study. Journal of Medicine this month. The FDA advisory committee voted overwhelmingly against the third installment for everyone aged 16 and over in September last year because experts felt there was not enough evidence to support such a decision. Two months later, the FDA approved Moderna and Pfizer enhancements for all adults without an advisory board meeting and then reduced the eligibility for December and January to include all 12 years and older.
