May 8, 2021


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

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Johnson & Johnson scientists are advocating for the Food and Drug Administration to grant emergency clearance for its single-injection Covid-19 vaccine, which could bolster vaccination efforts in the United States and across the world.

The company told a panel of experts on Friday that its vaccine was safe and effective and had been proven through multiple clinical trials.

If the panel gives the green light after Friday’s meeting, the FDA could authorize the vaccine as early as this weekend, making it the third authorized vaccine in the United States and the first to work after a single dose.

Johan Van Hoof, head of global therapeutics at Janssen, the pharmaceutical division of J&J, told the panel on Friday: “Jensen’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 stability and transport conditions compatible with existing distribution channels.”

J&J said it was ready to ship 4 million doses immediately. 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.

The FDA has already granted emergency clearance to vaccines manufactured by BioNTech / Pfizer and Moderna, of which nearly 70 million doses have been administered.

A report earlier this week from FDA staff confirming 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 shows signs of working against the more transmissible 501.V2 variant now. widespread in South Africa. Trials showed the vaccine was 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 among 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 TF’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 feared the downtrend was stagnating.

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 it is produced on a not-for-profit basis, making it more likely to be widely adopted in developing countries.

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