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FDA advisers vote unanimously to recommend booster doses of J&J vaccine

Vaccine advisers to the U.S. Food and Drug Administration voted unanimously Friday to recommend a booster dose of Johnson & Johnson's coronavirus vaccine at least two months after people get the first dose.

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By
Keely Arthur
, WRAL reporter, & Heather Leah, WRAL multiplatform producer
WASHINGTON — Vaccine advisers to the U.S. Food and Drug Administration voted unanimously Friday to recommend a booster dose of Johnson & Johnson's coronavirus vaccine at least two months after people get the first dose.

The FDA's Vaccines and Related Biological Products Advisory Committee voted 19-0 to recommend the extra dose for all recipients age 18 or older of the J&J Janssen vaccine. Doctors say data show a booster will provide significant extra protection against COVID-19, including the virus' delta variant, with no increase in adverse effects.

The FDA will now consider the committee's advice. Then the Centers for Disease Control and Prevention's vaccine advisers will be asked to consider it.

Steve Adkins, the owner of Health Park Pharmacy, in Raleigh, said he's already ordered 400 to 500 doses of the Janssen vaccine in anticipation of approval of the booster shots, which he said he hopes comes in the next week.

"The Johnson & Johnson vaccine is a great tool for us, for people who are on the go, transient populations, people who might not get their second dose," said Adkins, whose staff is already administering Pfizer vaccine booster shots.

According to Dr. Penny Heaton, global therapeutic area head of vaccines for Janssen, the efficacy of a single dose of the company's vaccine is 74% against severe disease and 70% against all symptomatic disease, with efficacy persisting for more than six months. However, the booster shot pushes those numbers to 94% protection against symptomatic disease and complete protections against severe COVID-19.

More than 9,000 people received a booster dose of the vaccine in clinical trials, Heaton said, adding that data show the safety and side-effects were similar, with "no increase in unsolicited adverse events."

A booster shot given at six months was more potent than given at two months, with a 12-fold increase in antibodies, she said.

"Regardless of the timing when you get the booster, we see increased antibodies against all the variants we have tested," Heaton said. "We want to provide optimal protection against COVID, and we know that a booster dose will do that.”

Right now, 5.2 million North Carolinians are fully vaccinated with either the Pfzier or the Moderna vaccine, while only 422,000 opted for the one-shot Janssen vaccine. Statewide, 54 percent of the population is fully vaccinated.

"If we can get down to less than 20 percent of the population not being vaccinated, we will be at a good place," Adkins said.

Mix-and-match vaccine boosters

Another discussion point in Friday's FDA committee meeting was the efficacy and safety of mixing vaccines for booster shots.

  • Can one vaccine be used to boost a different vaccine?
  • Is it safe to mix vaccines?
  • What happens to the immune response after booster vaccination?

A trial is underway to learn more about the safety of the "mix-and-match" approach, according to Dr. Kirsten Lyke, with the University of Maryland School of Medicine Center for Vaccine Development and Global Health. However, the trial doesn't provide data on the efficacy of this approach.

The current trial metrics are set up to "give us a high probability of observing at least one adverse event with a true event rate between 2% and 10%," Lyke said. However, the trial hasn't been designed to capture uncommon or rare adverse events, she said.

The trial also isn't powered to compare between groups, Lyke said.

"The neutralizing antibodies did increase in response to any boost, irregardless of the primary vaccination series," she said.

The "mix and match" had as good or higher neutralizing antibodies following the boost at day 15.

Lyke said, in general, antibodies were highest in those who had Moderna as their initial vaccine, followed by Pfizer and then Janssen, regardless of what booster they took.

Safety results from boosters in medical trial

Safety results seemed mostly positive. Data showed two serious adverse events during the trial, but both were deemed unrelated – and at least one of them was following a separate incident involving an accident.

There were no new onset chronic medical conditions as a result of the booster shots, according to Lyke.

One related adverse event of special interest was reported with a Janssen booster shot – severe vomiting leading to a medically attended visit the day after the shot.

There were three unsolicited adverse events deemed related to the booster shot. There was a fairly even distribution of adverse events across Moderna, Pfizer or Janssen, and most of them were Grade 1 or 2 in severity. There were four Grade 3 events, including incidents of vomiting, fatigue and insomnia.

Around 75% to 85% of people experienced pain and tenderness. There were reports of headache and fatigue, particularly in those who had received the Moderna vaccine series.

"There were no significant safety concerns identified within this short time period," said Lyke. However, she did acknowledge the trial moved rapidly due to desire to collect information quickly.

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