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WASHINGTON, Feb 26: An American panel of independent experts voted unanimously on Friday to recommend the Covid-19 injection of a Johnson & Johnson dose for emergency approval, paving the way for a third vaccine to begin shipping soon to the worst-affected country. of the world.
The 22 members of the committee were convened by the Food and Drug Administration and included leading scientists, as well as representatives from industry and consumers.
Although its recommendations are not binding, they are generally followed.
An emergency use authorization (US) is likely to follow, likely in the next few days, making the J&J vaccine the third to receive the green light in the United States after Pfizer and Moderna were tentatively approved in December.
“We’ve all seen the news about (the) Johnson and Johnson vaccine today, (the) third safe and effective vaccine,” said President Joe Biden from Houston shortly after the vote.
“We will use every way imaginable to expand vaccine manufacturing … and make even faster progress in delivering (injections) to people’s arms.”
Administration officials said this week they expected to administer three to four million doses next week.
The recommendation followed a day-long live-streamed virtual meeting to decide whether the drug’s known benefits outweigh the known risks for use in people 18 and older, giving the public an insider’s view of the details. of the scientific debate. .
“The Janssen vaccine candidate will play a critical role in global efforts to combat Covid-19,” Johan Van Hoof, global director of vaccine research and development at J & J’s Janssen subsidiary, told the meeting, emphasizing the high efficacy. injection against severe Covid-19. 19, even against new variants.
He also highlighted the fact that it has been proven to work with a single shot and can be stored long-term at refrigerator temperature, which “offers logistical and practical advantages.”
Placebo crossover
In a global trial of nearly 40,000 people, the vaccine’s efficacy against severe disease was 85.4 percent, but fell to 66.1 percent when moderate forms of the disease are included.
This makes it slightly less protective than the two-shot regimens from Pfizer and Moderna, which are around 95 percent effective against symptomatic Covid-19.
However, experts say the J&J shooting will bring with it 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 request to amend its trials so that people who received the placebo could now receive the vaccine.
The idea is to compare the relative effectiveness between people who got vaccinated before and after, to see if immunity wanes over time.
The company also plans to start testing its vaccine in children soon.
It is separately studying whether two doses might be more protective than one, raising concerns among some panelists who felt that people who received one dose could be disappointed if two doses end up proving to be more effective.
Anaphylaxis case
During the J&J presentation, the company scientist Macaya Douoguih revealed that a case of anaphylaxis occurred in a health worker in South Africa, the first time this happened with the vaccine.
Some rare cases of anaphylaxis have been reported for Pfizer and Moderna injections.
In nearly 44,000 people studied for safety reasons, the vaccine was well tolerated, with typical side effects such as injection site pain, headache, fatigue and muscle aches.
There were a handful of cases of people developing hives, which could have been related to the vaccine.
The FDA also said long-term follow-up was needed to determine if the vaccine was linked to a small number of cases of potentially dangerous clotting and tinnitus (ringing in the ears).
Seven people died from Covid-19 in the placebo group and none in the vaccine group.
There was an indication, based on preliminary data, that the vaccine might be partially effective against asymptomatic infection.
The company has announced that it aims to deliver a total of 20 million doses to the United States by the end of March, with 100 million by June, although the United States is pushing to accelerate that schedule.
The J&J vaccine uses an adenovirus that causes the common cold, which has been genetically modified so that it cannot replicate, to deliver the gene for a key coronavirus protein into human cells.
Those cells then produce that protein, which in turn trains the human immune system in case it finds the real virus. AFP
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