- The Washington Times - Tuesday, October 5, 2021

Drugmaker Johnson & Johnson asked the Food and Drug Administration to authorize a booster dose of its one-shot COVID-19 vaccine Tuesday, formally adding its voice to the booster debate.

J&J’s application is based on a study that showed a second dose increased protection against symptomatic disease from 74% to 94%.

“We look forward to our discussions with the FDA and other health authorities to support their decisions regarding boosters,” said Dr. Mathai Mammen, global head of research and development at Janssen, a pharmaceutical arm of J&J.

Roughly 15 million Americans have received a J&J vaccine but until now, they’d been left out in the cold when it comes to boosters.

President Biden announced a plan in August to provide extra doses to recipients of the Pfizer-BioNTech and Moderna versions, which require two doses and use different technology, although regulators have scaled back his ambitions.

The FDA approved a Pfizer booster for subgroups, namely older adults and people who are immune compromised, and Moderna’s application was working through the pipeline ahead of J&J’s announcement.

Now, the FDA’s advisory panel on vaccines will meet on Oct. 14 and 15 to discuss booster requests from Moderna and Johnson & Johnson.

Dr. Mammen told CNN that J&J will leave it up to federal agencies to decide who should get a booster and when — meaning the best interval between the first and second shot.

The J&J vaccine was touted this year as an efficient, “one and done” way to vaccinate swaths of the population.

However, the company faced manufacturing hiccups and a brief pause over rare blood-clotting issues. The fast-moving delta variant also fueled talk of adding booster doses against the virus sooner than anticipated.

J&J recently pointed to a study that found its single-shot vaccine remained relatively durable and 81% effective against hospitalization for at least eight months. For that reason, J&J said its rationale for boosters is to increase protection and not because of fears of waning immunity, as was the case with Pfizer.

“Our argument is not that our vaccine efficacy is fading or waning, but rather that from a personal standpoint, one can get to an even higher level of protection with a boost,” Dr. Mammen told CNN.

Because of that, there is some latitude in determining when to get the second dose, because “you’re not fighting a clock,” he said.

Also Tuesday, drugmaker AstraZeneca said it will seek the authorization of a groundbreaking antibody treatment to prevent COVID-19 in persons at high risk of disease.

The British company said its antibody-drug combination cut the risk of symptomatic disease by 77%. Three-quarters of people in the trial had underlying health conditions.

The AstraZeneca drug is notable because it is a preventive treatment for COVID-19 that can help a subset of at-risk people who don’t see much benefit from vaccines.

“Vulnerable populations such as the immunocompromised often aren’t able to mount a protective response following vaccination and continue to be at risk of developing COVID-19. With this first global regulatory filing, we are one step closer to providing an additional option to help protect against COVID-19 alongside vaccines,” said Mene Pangalos, executive vice president for AstraZeneca’s biopharmaceutical research and development.

Antibody cocktails from Regeneron, Eli Lilly and GlaxoSmithKline have been available for months but are used after someone contracts the virus to try to prevent hospitalization.

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