FDA Advisory Board Approves Johnson & Johnson’s Covid-19 Vaccine


A group of scientific advisers to the U.S. drug regulator have unanimously approved Johnson & Johnson’s Covid-19 vaccine, paving the way for the first one-shot authorization.

The 22 experts voted that the vaccine’s benefits outweighed its risks for people aged 18 and older, based on the available evidence.

The Food and Drug Administration could announce the third emergency use authorization for a Covid-19 vaccine as early as this weekend, adding another option to the U.S. vaccination portfolio, alongside BioNTech / Pfizer jabs and Moderna which are already being deployed.

However, J&J will deliver fewer doses than the 10 million previously planned by the US government. He has 4m to ship immediately and plans to hit a target of 100m by the end of June.

The company told an FDA expert advisory group on Friday that its vaccine was safe, effective and had been proven through multiple clinical trials.

Johan Van Hoof, head of global therapeutics at Janssen, the pharmaceutical division of J&J, told the panel on Friday: “Janssen’s vaccine candidate would play a critical role in global efforts to fight Covid-19. . . [It has been found] to provide substantial protection, in particular against Covid-19, including hospitalization and death, regardless of the variant.

“It is well tolerated and safe, and it is a single dose regimen, with compatible stability and transport conditions within existing distribution channels.”

Authorization of the J&J vaccine will help bolster U.S. supplies as the Biden administration rushes to distribute the vaccines as quickly as possible.

Over 70 million doses of BioNTech / Pfizer and Moderna vaccines have been administered.

A report earlier this week from FDA staff confirmed that the J&J jab was up to 88% efficient to prevent serious or critical illness, but only up to 78 percent effective in preventing moderate to severe illness.

Significantly, it also showed signs of working against the 501 variant. V2 is no longer transmissible now. widespread in South Africa. Trials showed the vaccine to be 82% effective in preventing serious or critical illness at the test site in South Africa and 64% effective in stopping moderate to severe illness.

FDA scientists said the vaccine showed no signs of side effects that would prevent them from authorizing it. The main complaints from recipients were pain at the injection site, headache and fatigue, as has been reported with Moderna and BioNTech / Pfizer vaccines.

Officials from the US Centers for Disease Control and Prevention said on Friday that by mid-February, with 55 million doses administered, there had been no significant increase in potential side effects such as accidents. cerebrovascular disease and seizures in those who had received Moderna or BioNTech / Pfizer vaccines.

Although relatively few pregnant women have so far received a vaccine, the CDC added that it has also not seen any worrying signs of serious side effects in these people.

The CDC has previously warned that vaccines can cause severe allergic reactions, but only in a very small proportion of people with previously identified allergies.

According to the organization’s latest data presented on Friday, there were an average of 4.2 severe allergic reactions to the BioNTech / Pfizer injection per million recipients, and 2.5 per million to that given by Moderna. This compares to 1.3 cases per million after a flu shot.

Latest news on coronaviruses

Follow FT’s live coverage and analysis of the global pandemic and rapidly evolving economic crisis here.

This week, the number of coronavirus deaths in the The United States spent 500,000 – by far the highest death toll in the world in absolute terms – underscoring the urgent need to increase vaccinations to prevent a new outbreak of infections, especially emerging variants.

While the level of new infections has been in decline in the United States in recent weeks, Rochelle Walensky, director of the CDC, told reporters on Friday that she was concerned the downtrend could stagnate.

As the first single-injection vaccine, J & J’s vaccine will be an important contribution to the global race to inoculate people. The vaccine is easy to transport and store, and is produced on a not-for-profit basis, making it more likely to be widely adopted in developing countries.



Source link

Leave a Reply

Your email address will not be published. Required fields are marked *