Experts back new Covid jab use
PENNSYLVANIA: A US panel of independent experts voted unanimously on Friday (Saturday in Manila) in favor of recommending Johnson & Johnson’s one-dose Covid-19 shot for emergency approval, clearing the way for a third vaccine to soon begin shipping in the world’s hardest hit country.
The committee’s 22 members were convened by the Food and Drug Administration and includM ed leading scientists as well as consumer and industry represenM tatives. Although their recommenM dations aren’t binding, they are usually followed.
An Emergency Use AuthorizaM tion or EUA will likely follow, probably in the coming days, making the J&J vaccine the third to be green lighted in the United States after Pfizer’s and ModerM na’s were provisionally approved in December.
“We’ve all seen the news about [the] Johnson and Johnson vaccine today — [the] third, safe effective vaccine,” President Joe Biden said from Houston shortly after the vote. “We’re going to use every conceivable way to expand manuM facturing of the vaccine... and make even more rapid progress in getting [shots] to people’s arms.”
Administration officials said this week they hoped to deliver 3 to 4 million doses next week.
The recommendation followed a dayMlong, liveMstreamed virtual meeting to decide if the known benefits of the drug outweigh its known risks for use in people aged 18 and over — which gave the public an inside look at the details of the scientific debate.
“Janssen’s vaccine candidate will play a critical role in the global efforts to fight Covid-19,” Johan Van Hoof, global head of vaccines research and development at J&J’s Janssen subsidM iary, had told the meeting, emM phasizing the shot’s high efficacy against severe Covid-19, including against new 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 pracM tical advantages.”
In a global trial of almost 40,000 people, the vaccine’s efficacy against severe disease was 85.4 percent, but it fell to VV.1 percent when including moderate forms of the disease.
This makes it slightly less protective than Pfizer and ModM erna’s twoMshot regimens, which both have an efficacy of around 95 percent against symptomatic Covid-19.
Nevertheless, experts say J&J’s shot will bring to bear a powerful new weapon against the outbreak in the United States, where more than 500,000 people have died. Van Hoof said 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 soon begin testing its vaccine on children.
It is separately studying whether two doses might be more protective than one — which raised concerns among some panelists who felt people who got one dose might feel shortMchanged if two doses end up proving more effective.