Wednesday , April 21 2021

FS authorizes Johnson & Johnson’s COVID-19 vaccine



WASHINGTON: The United States authorized Johnson & Johnson’s COVID-19 vaccine for emergency use on Saturday (February 27), giving the nation a third shot to combat the outbreak that has killed more than 500,000 Americans.

The one-shot vaccine is very effective in preventing serious COVID-19, including against newer variants, the Food and Drug Administration (FDA) said before approving it.

“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to assist us in the fight against this pandemic,” said Janet Woodcock, Acting Director of the United States Regulatory Commission.

The FDA announced the authorization for emergency use for adults 18 and older after unanimous approval Friday by the Bureau of External Experts.

In large clinical trials, the effectiveness of the vaccine against severe disease was 85.9 percent in the United States, 81.7 percent in South Africa, and 87.6 percent in Brazil.

Overall, among 39,321 participants in all regions, the efficacy against severe COVID-19 was 85.4 percent, but it fell to 66.1 percent when taking moderate forms of the disease.

Importantly, analyzes of different demographic groups did not reveal significant differences in age, race, or people with underlying conditions.

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US President Joe Biden welcomed the “exciting” announcement, but warned that the nation could not fail its guard.

“This is exciting news for all Americans, and an encouraging development in our efforts to end the crisis,” Biden said in a statement after the J&J vaccine was given the green light.

“But we can not abandon our guard now or assume that victory is inevitable.”

HOW DIFFERENT FROM THE FAXES OF PFIZER AND MODERNA?

The faxes Pfizer-BioNTech and Moderna use new messenger RNA technology to trigger an immune response and both require two recordings. The J&J vaccine includes a more conventional approach, using a common cold virus to inject coronavirus proteins into cells to activate an immune response.

The vaccine remains stable for at least three months at normal refrigerator temperatures, while the Moderna vaccine should be shipped frozen and the Pfizer BioNTech option should be shipped and stored at even colder subarctic temperatures.

These factors make it easier to vaccinate larger numbers of people, even in areas with poor transport and storage infrastructure.

Pfizer-BioNTech and Moderna faxes were approximately 94 per cent to 95 per cent effective in trials conducted in the United States where variants did not circulate.

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Both mRNA vaccines showed higher efficacy rates in their trials than J & J’s vaccines, but experts warned against too much difference between the faxes because the trials had different endpoints and J & Js were performed while highly transmissible new variants of the virus circulated.

Novavax, which tests its vaccine in South Africa, said it was 60 percent effective in preventing mild, moderate and severe COVID-19 in patients without HIV. It said about 90 per cent of the cases in the study involved the new South African variant. The mid-stage trial in South Africa involved 4,400 patients.

The vaccine developed by AstraZeneca with Oxford University provided only minimal protection against mild to moderate COVID-19 of the South African variant in a relatively small sample. There was as yet no data on their effectiveness in preventing severe disease in people infected with the variant, as the study included mostly young adults who were not considered to be at high risk for serious illness.

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DELIVERY DEALS

J&J expects to produce at least one billion doses of its vaccine by 2021 and has signed delivery agreements for most of them.

The United States has agreed to pay more than US $ 1 billion for 100 million doses and can purchase an additional 200 million doses.

Other deals include 22 million doses for Mexico, 9 million for Colombia, 30 million for the United Kingdom, 4 million for South Korea and 400 million for the European Union. It plans to deliver $ 500 million to poorer countries, working with the COVAX alliance.

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