Fourth COVID-19 shot approved, but disputed

LILO H. STAINTON, HEALTH CARE WRITER | MARCH 30, 2022

NJ Spotlight News

Vaccinated individuals 50 years or older — and those as young as 12 who are significantly immunocompromised — can now get a second COVID-19 booster shot, thanks to federal government decisions Tuesday designed to increase protection among those at higher risk of infection.

But experts appeared split on the need to allow for a second booster, or fourth shot of the mRNA vaccines made by Pfizer and Moderna. Some saw little downside and welcomed the potential additional protection in the announcement that has been rumored for weeks. “I think the benefit outweighs the risk,” said Rutgers School of Public Health Dean Perry Halkitis.

Others questioned the government’s decision-making process, which didn’t involve the same public review as previous COVID-19 vaccine policies, and the timing of the move, given the current low prevalence of disease. “In my opinion, there really doesn’t appear to be — right at this moment, today — an urgency for people to go out and get a fourth dose,” said Dr. Eddy Bresnitz, a vaccine expert and former adviser to the state’s pandemic response team.

The decision to permit an additional booster shot for these groups comes as COVID-19 infection numbers have plunged nationwide and in New Jersey, where new diagnoses and hospitalizations have remained fairly stable in recent weeks. It also follows shifts by federal and state governments to downsize pandemic infrastructure and as a national fund for testing and vaccination among uninsured residents has run dry — a situation that worries both Halkitis and Bresnitz.

The state Department of Health, which oversees New Jersey’s vaccination efforts, did not respond to requests for comment on the developments Tuesday. Halkitis and Bresnitz said it is unlikely that the state will need to revise its immunization program, given the relatively low demand for shots these days. “I can’t imagine DOH will be standing up (vaccination) mega-sites for this. There won’t be the demand,” Bresnitz said. Both agreed the second booster could make sense for those who face higher risk because of chronic illness, occupation or other factors, or those who are immunocompromised.

Departure from previous approval process

More than 6.8 million New Jerseyans are fully vaccinated against COVID-19 — with either two doses of Pfizer or Moderna vaccine or a single shot of the Johnson & Johnson serum — and some 3.2 million have also had a booster. But more than one in five eligible residents are not immunized, according to state data, and vaccine protection varies significantly by county.

Early Tuesday the Food and Drug Administration announced that it had amended the emergency use authorizations provided to Pfizer and Moderna to permit additional boosters for certain immunocompromised individuals and anyone age 50 or above. This includes almost 3.3 million New Jerseyans, according to census data.

Later in the day the Centers for Disease Control and Prevention updated its guidance to vaccine providers to say they should immediately make the booster shots available to those who are eligible under the FDA amendment. It did not offer any additional data or recommendations on the policy change.

Bresnitz, who spent more than a decade working on vaccines at Merck and previously oversaw New Jersey’s communicable disease service, said the approval  process for this round of booster shots reflected a significant departure from the way the two federal agencies handled previous decisions around COVID-19 vaccines. In the past, approvals involved detailed debate — including public advisory committee meetings — on the data on efficacy and safety, equity questions and the feasibility of policies, he said.

This time the FDA provided only limited data to the public and appeared to base its recommendation largely on Israeli studies that showed no additional safety concerns with a fourth shot. “This was completely outside the protocol of what’s been followed over the last year and a half, two years,” Bresnitz said, noting there is little information on the true benefits of another shot, a concern shared by other epidemiologists in social media posts and media reports.

Questioning the need

Questions about the need for a fourth shot, or second booster, have long swirled in public. Leaders at Pfizer and Moderna have said they would at some point be necessary, given how vaccine protection wanes over time against infection and, to a lesser degree, hospitalization and death. Pfizer had asked the FDA to approve the extra shot for people 65 years and older while Moderna sought the agency’s go-ahead to provide another booster to anyone over age 17, according to The Associated Press.

Instead, the FDA indicated a second booster from either brand could be administered to Americans age 50 and older starting four months after they received their last shot, regardless of health status. The agency also approved the use of a fourth shot in younger people who have had an organ transplant or face similar immune risks, also to be administered four months after their last shot. Additional Moderna boosters can now be used for these individuals age 18 and older, and a Pfizer booster is now available for immunocompromised people over age 11.

Halkitis — who is “sixty minus one,” healthy and already got a fourth shot — said the announcement makes sense, regardless of low current demand. “I think it is wise putting it out now,” he said. “This is the time we want to get people ready to get vaccinated and boosted. Because come the fall, when respiratory disease is really on the rise, you want people to have the full protection that they can possibly have as we deal with the surge that will surely happen.”

Bresnitz — who is 65, healthy and does not plan to get another shot soon, unless there is a surge — called it a “wishy-washy public policy” decision that has yet to be fully justified as a true public health benefit. It may be more sensible to wait until we are closer to fall, he said, or until COVID-19 vaccines have been tweaked to better protect against future variants “We can’t keep boosting our way out of this on a four-to-five-month basis,” he said.

In a press release, the FDA said its decision was informed by data reported by Israel that showed no new safety concerns among some 700,000 people there who received a fourth Pfizer vaccination at least four months after their third shot. A separate study of 120 people who got an additional Moderna booster also revealed no new concerns, the agency said.

The FDA decision did not involve Johnson & Johnson’s COVID-19 vaccine, for which the agency previously recommended a booster just two months after the initial single-dose shot.

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published this page in News and Politics 2022-03-30 02:52:34 -0700