J&J COVID-19 Second Shot Gets Expert Support; FDA plans to lower age of Pfizer recall

U.S. Food and Drug Administration outside advisers on Friday unanimously recommended that the agency allow a second injection of Johnson & Johnson’s COVID-19 vaccine for all recipients of the single-dose inoculation.

The agency is also considering lowering the recommended age for booster shots of the Pfizer / BioNTech vaccine to people as young as 40, FDA chief Dr Peter Marks told the advisory committee. The FDA’s Advisory Committee on Vaccines and Related Biologics has supported injections for all recipients of J&J aged 18 and older at least two months after their first dose. The FDA is not required to follow the recommendation, but generally does.

After hearing presentations from scientists at J&J and the FDA, many members of the advisory committee questioned whether J & J’s single-dose vaccine should in fact be considered a two-dose vaccine for everyone. They pointed out the lower levels of virus neutralizing antibodies it causes compared to vaccines using messenger RNA (mRNA) technology from Moderna Inc and Pfizer / BioNTech.

“There is a public health imperative. What we are seeing is that this is a group whose overall efficacy is lower than what we have seen with the mRNA vaccine, and therefore something urgent needs to be done, ”said Dr. Arnold Monto, epidemiologist at the School of Public at the University of Michigan. Health who chaired the meeting.

The FDA last month cleared recalls of the Pfizer / BioNTech vaccine for Americans aged 65 and older and those at high risk of serious illness or occupational exposure to the virus. Marks, director of the FDA’s Center for Biologics Evaluation and Research, said data from Israel, where Pfizer’s booster shots have already been widely administered, suggests the vaccine’s effectiveness is waning and argues for a lowering of the age for receiving booster injections to 40 years. Concerns about the rare cases of heart inflammation in younger men who receive the Pfizer / BioNTech vaccine also made 40 a good cut-off point for additional injections, Marks said.

J&J DATA CONCERNS

Marks expressed concern that the data presented by J&J did not reflect all of the information on vaccine performance. “There are real challenges here. Not all of the data fully supports the fact that this is a vaccine that retains excellent potency over time, against all forms of disease or even against severe forms of disease, ”said Marks.

J&J scientists said their vaccine was more durable than mRNA vaccines. “If the vaccine is not adequate, it should be strengthened and everyone should get it,” said Dr Eric Rubin, infectious disease expert at the Harvard Chan School of Public Health.

After the vote, Rubin said he expects getting the second dose of J&J more than two months after the first to be safe. Although the data is scarce, he said, “there is not much to suspect that this is wrong,” adding: “I certainly support these people being given another dose.

“Once the FDA approves the second dose, the US Centers for Disease Control and Prevention will make specific recommendations on who should get the injections. CDC advisers are due to meet to discuss boosters next week.

On Thursday, the panel unanimously supported Moderna’s COVID-19 vaccine booster injections for Americans aged 65 and older and those at high risk of serious illness or occupational exposure to the virus.

U.S. health officials have come under pressure to allow the additional injections after the White House in August announced plans for a massive recall campaign pending FDA and CDC approvals.