In the US, older people are advised to take four vaccinations against COVID-19

On March 29, top U.S. health authorities approved fourth doses of Pfizer and Moderna's Covid-19 vaccine for people aged 50 and over amid a more contagious version of Omicron and a new wave of U.S. infections. CNBC.

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The FDA has cleared Pfizer and Moderna for a fourth dose for everyone aged 50 and over, as well as a fifth dose for some young people with weakened immune systems. People aged 12 and over with a weakened immune system are eligible for a fifth dose of Pfizer, and those aged 18 and over with a weakened immune system are eligible for Moderna.

The Centers for Disease Control and Prevention quickly approved the decision, paving the way for those eligible to receive a new booster cycle. The CDC also recommended that all adults who have received two doses of the Johnson & Johnson vaccine receive a third vaccination using Pfizer or Moderna. Adults who have received the J&J vaccine and a second Pfizer or Moderna shot are not yet eligible for a third dose unless they are over the age of 50 and have a weakened immune system.

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All new boosters should be administered at least four months after the last vaccination.

The FDA and CDC have taken the decision without convening meetings of their vaccine advisory committees, a rare move that the agencies have taken more frequently during the pandemic to expand the use of already approved Covid vaccines. The drug regulator's clearance comes just two weeks after Pfizer and Moderna petitioned the FDA to allow a second booster shot based on data from Israel.

The FDA Vaccine Advisory Committee is due to meet on April 6 to discuss the future of booster shots in the US. Vaccine experts are expected to have a broad discussion on booster shots and not vote on a specific recommendation.

Dr. Peter Marks, head of the FDA's office in charge of vaccine safety and efficacy, said the regulator did not call for a consultation because the decision was "relatively simple."

“This is the fourth booster that we have now received evidence of from Israel. It is supposed that, having received it, it is possible to reduce the risk of hospitalization and death of older people, ”Marks said during a conversation with reporters after the decision was made.

Dr. Paul Offit, a member of the committee, criticized the regulator for moving forward without holding a public meeting where the American public can hear experts evaluate the data and make recommendations to the FDA on the best way forward. The Vaccine Advisory Committee's recommendations are non-binding, but they help ensure transparency to the public.

“It’s just a fait accompli,” Offit said of the FDA approval. “So that’s how it works?” We talk endlessly about how we follow the science - it doesn't seem to work."

The FDA has not called on committee members to make booster recommendations since last fall, when they voted for a third dose of Pfizer or Moderna for people aged 65, older, and younger who are at risk for severe Covid.

Health experts disagree on whether a fourth dose of the vaccine is needed right now, although the debate is nuanced. There is broader agreement that the elderly or those with compromised immune systems may benefit from additional protection. Another booster shot for young, healthy adults is more controversial as they are less susceptible to severe Covid-related illness.

Dr. Peter Hotez, a vaccine expert at Baylor College of Medicine in Houston, said some scientists believe the sole purpose of vaccines is to keep people out of the hospital. However, Hotez said vaccination policies should also aim to prevent infection and prolonged Covid.

The CDC published a study in February that showed that the effectiveness of the third dose against emergency room visits dropped from 87% to 66% against emergency room visits and from 91% to 78% against hospitalization four months after receiving the shot.

"It makes me think that boosters don't necessarily work the way we would like," said Hotez, who strongly supports a fourth dose based on Israeli data showing that one more booster increases protection for people over 60.

Israeli scientists in a study published last week found that the death rate from omicron was 78% lower among older adults aged 60 to 100 who received their fourth dose of Pfizer, compared to those who received just three shots. The study, which was not peer-reviewed, examined the medical records of more than 500 people from January to February at Clalit Health Services, Israel's largest healthcare provider.

The FDA's decision to allow a fourth dose for those aged 50 and over was broader than Pfizer's request and narrower than Moderna's. Pfizer has asked the FDA to allow fourth doses for those aged 65 and over, while Moderna has asked the regulator to allow them for all adults aged 18 and over. Moderna CEO Stephane Bancel revealed last week that the biotech company has filed a broader request to give the FDA the flexibility to decide which age group needs a fourth dose 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, overarching imposition that does not distinguish between the different needs of older and younger adults.

“An elderly and frail person needs an extra dose of the vaccine much more than a young healthy athlete,” Moore said.

The approval for a fourth vaccination comes as a more contagious sub-variant of omicron, BA.2, has caused new waves of infection in major European countries and China, which has been battling its worst outbreak since 2020. BA.2 has spread to the US since February. It is expected to become the dominant option in the coming weeks. White House chief medical adviser Dr. Anthony Fauci said U.S. infections could increase due to BA.2, although he does not expect a new wave.

“We hope that by taking these actions, we will help people protect themselves if we have another wave that passes through this country,” Marks said.

BA.2 does not generally cause more serious illness in humans than the earlier version of omicron, BA.1, and the vaccines have the same level of effectiveness against both types of variant, according to studies in South Africa and Qatar, among others. None of the studies were peer-reviewed.

It's unclear if the FDA will approve a fourth dose for young adults at some point, as there is less data now to support such a decision. Marks said the US may need a more general booster campaign for people under 50 in the fall, when Covid is likely to start spreading again and immunity wanes. He also said the US might have to switch to a variant-targeted vaccine like omicron. Current vaccines have been developed against the Wuhan strain.

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An Israeli study conducted in February among healthcare professionals aged 18 and over found that the fourth dose did not boost immunity, but restored it to the maximum strength of the third dose. Many study participants who received the fourth dose did become infected, albeit with mild or no symptoms at all.

"A fourth vaccination of healthy young healthcare workers may have only marginal benefits," wrote Dr. Gili Regev-Yochai and the team of scientists from the Sheba Medical Center and the Israeli Ministry of Health who conducted the study.

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