U.S. Experts Debate J&J Covid Vaccine Authorization


A U.S. panel of independent experts was meeting Friday to discuss whether to grant Johnson & Johnson's Covid-19 shot emergency approval, likely paving the way for a third vaccine to start shipping in the world's hardest-hit country.

The committee's 22 members, who were convened by the Food and Drug Administration and include leading scientists as well consumer and industry representatives, will hold a daylong, live streamed virtual meeting to decide if the known benefits of the drug outweigh its risks for use in people 18 and over. 

"If authorized, Janssen's vaccine candidate will play a critical role in the global efforts to fight Covid-19," Johan Van Hoof, global head of vaccines R&D and J&J's Janssen subsidiary told the meeting, emphasizing the shot's high efficacy against severe Covid-19, including against new, concerning variants.

He also stressed the fact that it was proven to work with a single-shot, and could be stored long term at fridge temperatures, which "offers logistical and practical advantages." 

The panel will vote around 5:00 pm Eastern (2200 GMT) and though their recommendations aren't binding, they are usually followed. The members are widely expected to vote in favor. 

An emergency use authorization (EUA) would soon follow, making the J&J vaccine the third to be greenlighted in the United States after Pfizer's and Moderna's were provisionally approved in December.

Administration officials said this week they hoped to deliver three to four million doses next week, pending emergency authorization.

- Placebo crossover -

In a global trial of almost 40,000 people, the vaccine's efficacy against severe disease was 85.4 percent, but it fell to 66.1 percent when including moderate forms of the disease.

This makes it slightly less protective than Pfizer and Moderna's two-shot regimens, which both have an efficacy of around 95 percent against all forms of Covid-19 from the classic coronavirus strain.

It's also possible the experts might seek an age-cap, given that only around 1,500 participants in the trial were over the age of 75.

Nevertheless, experts say J&J's shot will be another invaluable tool in bringing the outbreak to a close in the United States, where more than 500,000 people have died.

Van Hoof announced that if authorized, J&J would apply to amend their trials so that people who received the placebo could now receive the vaccine. 

The idea is to compare relative efficacy between people who were vaccinated earlier against later, to see if immunity wanes over time.

The company is also planning to test its vaccine on children -- and is studying whether two-doses might be more protective than one.

- Anaphylaxis case -

During J&J's presentation, company scientist Macaya Douoguih revealed that a case of anaphylaxis occurred in a health worker in South Africa -- the first time this has occurred for the shot. 

Some rare anaphylaxis cases have been reported or the Pfizer and Moderna shots. 

Overall though, the vaccine is well-tolerated, with typical side-effects like injection-site pain, headache, fatigue and muscle pains.

There was a hint, based on preliminary data, that the vaccine might be effective against asymptomatic infection -- though J&J said it needs to do more research to confirm this.

The company has announced it aims to deliver a total of 20 million doses by the end of March, with 100 million by June -- though the U.S. is pushing to expedite that timeline.

The J&J vaccine uses a common-cold causing adenovirus, which has been genetically modified so that it can't replicate, to carry the gene for a key protein of the coronavirus into human cells. 

Those cells then produce that protein, which in turn trains the human immune system should it encounter the real virus.

Other adenovirus vector vaccines against Covid-19 include those made by AstraZeneca-Oxford and Russia's Sputnik V.

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