Novavax Covid-19 vaccine is under scrutiny by FDA advisers

The outside panel’s review of the two-shot vaccine on Tuesday would bring the vaccine closer to its availability in the United States. The FDA is expected to make a decision on whether to authorize the vaccine shortly, after reviewing its advisers’ vote.

The Centers for Disease Control and Prevention would then decide whether or not to recommend using the vaccine, before the shots become widely available.

Novavax says vaccine would appeal to people reluctant to receive vaccines made by Pfizer Inc.

and partner BioNTech SE or by Moderna Inc.,

which are each based on the relatively new gene-based technology known as messenger RNA.

Overall, however, the use of Covid-19 vaccines and boosters has slowed in the United States, as many people eligible for vaccines have received them and grow weary of receiving extra doses. About 67% of the US population is fully vaccinated against Covid-19, according to the CDC. Less than half of the population has received a booster.

During its day-long meeting, the Vaccines and Related Biologics Advisory Committee reviews the company’s clinical trial data as well as FDA staff review.

Agency staff told outside advisers the vaccine was 90% effective against Covid-19 in its pivotal trial, but noted six “worrying” cases of heart inflammation among vaccinees.

Since the start of the Covid-19 pandemic in 2020, the scientific understanding of its transmission and prevention has evolved. Daniela Hernandez du – explains which strategies have worked to stem the spread of the virus and which are obsolete in 2022. Illustration: Adele Morgan

Novavax, of Gaithersburg, Md., brushed off those concerns in his presentation, saying the cases of myocarditis and pericarditis were consistent with what would be expected in the general population.

Outside advisers asked about combining the Novavax vaccine with mRNA vaccines already on the market, but the purpose of the meeting was to assess the benefits of Novavax as an initial two-shot regimen.

“I know there is strong interest in using this vaccine as a booster dose,” said Dr. Doran Fink, an FDA official. “We do not have the capacity to discuss this potential use today. »

The pivotal trial of the Novavax vaccine took place before the emergence of the Omicron variant. Studies have shown Omicron to be better able to evade licensed vaccines, but the impact on Novavax has not been determined.

A member of the advisory committee encouraged testing to assess the effectiveness of the Novavax vaccine against the variant.

The company’s Covid-19 vaccine would be the first licensed in the United States with a traditional protein-based platform, which has been used for decades to vaccinate against diseases such as hepatitis B and shingles.

It sends a version of the coronavirus spike protein to boost the body’s immune response. This is different from the market-dominating Pfizer-BioNTech and Moderna vaccines, which deliver mRNA to instruct the body to assemble a harmless version of the coronavirus spike protein, which then triggers the immune system to mobilize the tusks.

Johnson & Johnsonit is

The Covid-19 vaccine uses a modified version of an adenovirus, the virus responsible for many colds, to deliver genetic instructions to cells.

Novavax, based in Gaithersburg, Maryland, expects its vaccine to appeal to people hesitant to get vaccines based on gene technology.

News from Jon Cherry/Bloomberg

Novavax said it receives regular calls and emails from people waiting for its vaccine, and some experts have expressed hope that the vaccine might win over unvaccinated skeptics of the mRNA technology.

Kayb Joseph, a 47-year-old resident of Chattanooga, Tennessee, said she checks for Novavax vaccine news every two weeks and will visit the company’s headquarters in Maryland for the get if necessary. She prefers her protein-based platform.

“I just don’t believe in being someone’s R&D,” she said. “Novavax is still only the first version, but for me it is the second version of the traditional technology. »

Write to Liz Essley Whyte at [email protected]

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