J&J Vaccine Gets FDA Advisory Review; Signoff Possible Today

Johnson & Johnson’s coronavirus vaccine is being vetted by a panel of outside advisers to the U.S. Food and Drug Administration Friday, one of the final steps toward potential authorization of the country’s first one-dose immunization against Covid-19.

If the panel votes that the vaccine’s benefits outweigh its risks, as expected, the agency could grant emergency clearance within days, providing a badly needed boost to U.S. vaccine supplies. While the committee’s decision is non-binding, the FDA usually follows its advisers’ recommendations.

Biden administration officials have said the U.S. expects J&J to release 3 million to 4 million shots next week, assuming it’s authorized for use. The company is ready to deliver 20 million doses by the end of March, an executive said earlier this week at a congressional hearing.

J&J Vaccine Gets FDA Advisory Review; Signoff Possible Today

“If -- if -- the FDA approves the use of this new vaccine,” President Joe Biden said Thursday at an event to celebrate 50 million doses administered since he took office, “we have a plan to roll it out as quickly as Johnson & Johnson can make it.”

Johnson & Johnson’s vaccine was 72% effective in the U.S.-based portion of a global study that enrolled more than 43,000 people, FDA staff wrote in a document released earlier this week that summarized the company’s final-stage trial results, and was 100% effective in preventing death in the trial

It was highly effective against severe disease in all regions where tested and worked better against mutant strains than the company had previously reported. J&J’s scientists and FDA staff reviewed the data behind the vaccine in separate presentations, and there will be an in-depth panel discussion and vote.

The vaccine’s effectiveness against severe disease became apparent as soon as seven days after vaccination and increased over time, J&J officials said at the panel meeting, rising from almost 77% at least 14 days after vaccination to 85% efficacy starting 28 days after vaccination. It has continued to gradually increase over time through periods longer than 56 days after vaccination, said Macaya Douoguih, head of medical affairs at Janssen Pharmaceutical Companies of Johnson & Johnson.

The vaccine overall had a low rate of side effects. However, there were more cases of deep vein thrombosis and pulmonary embolism in the people who got the vaccine compared to the placebo group, said Yosefa Hefter, a medical officer in FDA’s Center for Biologics Evaluation and Research. Also, six people who got the vaccine had ringing in their ears, compared to none in the placebo group.

A handful of serious adverse events linked to the vaccine included a case of hypersensitivity leading to lip swelling and hives, and continuing arm pain in a 30-year-old that wasn’t responsive to painkillers, Hefter said.

There were also two cases of severe allergic reactions reported in a separate, independently-run study of 40,000 health-care workers in South Africa, a J&J spokesman confirmed.

J&J Vaccine Gets FDA Advisory Review; Signoff Possible Today

The all-day FDA meeting has included discussion of how existing vaccines are holding up so far in practice. In the morning, a Centers for Disease Control and Prevention official highlighted data on variants that are being closely watched for their threat to vaccine efficacy.

Pregant Women

Health officials discussed the importance of sequencing strains for key changes that have already made some less responsive to the immunity raised by vaccines. Panel member Eric Rubin, editor-in-chief of the New England Journal of Medicine, noted that US sequencing efforts will need to carefully sample both vaccinated and unvaccinated people to detect such strains.

“We hope to be able to get large numbers to have a representative set of specimens,” said Adam MacNeil of CDC’s National Center for Immunization and Respiratory Diseases. “It does remain an ongoing challenge.”

More than 30,000 women who reported themselves as pregnant have received Covid vaccines as of Feb. 16, Tom Shimabukuro of CDC’s National Center for Emerging and Zoonotic Infectious Diseases told the panel. Miscarriages reported in pregnant women who have received the vaccine haven’t occurred in numbers that raise safety concerns, he said.

J&J is planning to begin a study of the vaccine in pregnant women in March or April, Johan Van Hoof of the company’s Janssen unit, told the panel.

Read More: One Dose and Variant-Tested: The J&J Covid-19 Shot Explained

Separately, the CDC’s Advisory Committee on Immunization Practices has set up an emergency meeting on Sunday to consider the shot. This panel makes recommendations on how to use vaccines.

Different Approach

J&J’s vaccine differs from authorized shots from Moderna Inc. and the partnership of Pfizer Inc. and BioNTech SE, which rely on messenger RNA to turn cells into vaccine factories. It instead uses a non-replicating cold virus called an adenovirus to stimulate an immune response, preparing the body to fight Covid-19.

The J&J shot is highly anticipated because it could make it easier to quickly vaccinate people in far-flung places. While the mRNA vaccines require two doses for their full benefits to take hold, J&J’s single-shot regimen is less complicated to administer. It also can be kept in a refrigerator for three months, an advantage over the mRNA vaccines that must be frozen when stored for longer periods.

J&J’s candidate was among six vaccines tapped for the Trump administration’s Operation Warp Speed program, receiving some $1.5 billion in government backing. The company has a contract to deliver 100 million doses to the U.S. by the end of June.

J&J fell as much as 2.5% as of 3:26 p.m. in New York.

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