October 15, 2021 – An FDA advisory committee voted 19-0 on Friday to approve second doses of the Johnson & Johnson COVID-19 vaccine to boost immunity. It was the second vote in as many days to support a change in the schedule for a COVID vaccine.
In its vote, the committee said that boosters could be offered to people aged 18 and over. However, it is not clear that everyone who has received a Johnson & Johnson vaccine needs to be given a second dose. The same panel voted Thursday to recommend booster shots for the Moderna vaccine, but for a smaller group of people.
It will be up to a CDC panel next week to make more specific recommendations for those who may need another inclusion. The CDC Advisory Committee on Vaccination Practices is due to meet next Thursday to discuss issues related to COVID-19 vaccines.
Studies on the effectiveness of the J&J vaccine in the real world show that its protection, while good, was not as strong as the Pfizer and Moderna mRNA vaccines, which are given as part of a two-dose series.
In the end, members of the Advisory Committee on Vaccines and Allied Biological Products said they felt the company hadn’t argued to call its second vaccination a booster, but had provided enough data to suggest that anyone over 18 Should be years old Consider getting two shots of the Johnson & Johnson vaccine as a matter of course.
This is an especially important issue for adults over 50 to learn in theNew England Journal of Medicine found that older adults who received the Johnson & Johnson vaccine were less protected from infection and hospitalization than those who received mRNA vaccines.
The company presented data from six studies in support of a second dose to the FDA panel. The only study that looked at second doses after 6 months included only 17 people.
These studies showed that a second dose significantly increased neutralizing antibodies, which are the body’s first protection against COVID-19 infection.
But the company only recently released this data to the FDA, so agency scientists repeatedly stressed during the meeting that they did not have enough time to follow their normal process of independently reviewing the data and then analyzing the study results themselves.
Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said it took months to complete this rigorous review.
Instead, in the interests of urgency, the FDA said it had tried to shed some clarity on the tangle of presented study results, which included three dosage schedules and different measures of effectiveness.
“That’s how I notice it,” said committee member Paul Offit, MD, professor of pediatrics and infectious diseases at Children’s Hospital of Philadelphia. “I think this vaccine was always a two-dose vaccine. I think it’s better than two dose vaccine. I think it would be hard to recommend this as a single dose vaccine right now. “
“In my opinion, it was always necessary for J&J receivers to get a second shot.” said James Hildreth, MD, PhD, President and CEO of Meharry Medical College in Nashville, Tennessee.
Archana Chatterjee, MD, dean of Chicago Medical School at Rosalind Franklin University, said she changed her voice over the course of the meeting.
She said that based on the very limited safety and efficacy data presented to the committee, she was ready to vote against the idea of offering second doses of Johnson & Johnson shots.
But considering the 15 million people who were vaccinated with a single dose and studies that suggested that nearly 5 million older adults may still be hospitalized for having just had a vaccination, “This is still a commandment public health ”. ,” She said.
“I agree with most of my colleagues that this second dose, booster, whatever you want to call it, is necessary in these people to get their immunity back into the 90-plus percentile range,” she said.
Who needs a second dose?
On Thursday, the committee heard an update on data from Israel that saw a surge in serious breakthrough infections during the Delta wave.
COVID-19 cases there are rapidly declining after the nationwide booster doses of the Pfizer vaccine were used.
On Friday, the Marks told the FDA that the agency is aiming to add more flexibility to emergency approvals for Johnson & Johnson and Moderna vaccines so that boosters could be used more widely in the United States.
The FDA panel voted Thursday to approve a 50 milligram dose of Moderna’s vaccine – half the dose used in the first series of vaccinations – to boost immunity for at least 6 months after the second dose. Those who may need a booster vaccination are the same groups who received the green light for a third dose of Pfizer, including people over 65, adults at higher risk for severe COVID-19, and those who have one because of where they live or work are exposed to higher risk.
The FDA called on the committee on Friday to discuss whether boosters should be offered to young adults, including those without previous health conditions.
“We are concerned that what was seen in Israel is being seen here,” said Marks. “We don’t want to have a severe COVID-19 wave before we use boosters.”
Some committee members warned Marks to be careful about enlarging the EEA as it could confuse people.
“If we say immunity is going down, what are the effects?” said Michael Kurilla, MD, director of clinical innovation at the National Institutes of Health.
Overall, the data shows that all vaccines currently used in the US – including Johnson & Johnson – remain highly effective in preventing serious consequences of COVID-19 such as hospitalization and death.
Booster doses could prevent more people from having even mild or moderate symptoms of “breakthrough” COVID-19 cases, which began to rise during the recent delta surge. They are also expected to prevent serious consequences such as hospitalizations in older adults and those with underlying health conditions.
“I think we have to be clear when we say immunity is wearing off and we have to do something about it. I think we have to be clear about what we are really aiming for.” [with boosters] in terms of the clinical impact we expect, ”said Kurilla.
Others pointed out that preventing even mild to moderate infections is a worthwhile goal, especially given the long-term impact of COVID-19
“COVID has tremendous downstream effects, even on those who are not hospitalized. Whenever we can prevent significant morbidity in a population, there are benefits, ”said Steven Pergam, MD, medical director for infection prevention for the Seattle Cancer Care Alliance.
“I would really be in the camp moving towards a younger age group to allow boosters,” said Pergam.
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