Johnson & Johnson submits single dose COVID-19 vaccine candidate to FDA for emergency clearance

Johnson & Johnson on Thursday submitted its single-dose COVID-19 vaccine candidate for emergency consent to the Food and Drug Administration, calling it an “important step forward” in ending the pandemic.

The pharmaceutical giant’s move comes after it released data last week showing that it is about 72% effective in the US against the virus. If approved, it will be the third vaccine to be authorized in the US following Pfizer-BioNTech and Moderna being authorized in December.

“Today’s submission for emergency authorization for our COVID-19 vaccine for investigations is an important step towards reducing the burden of disease for humans worldwide and ending the pandemic,” said Johnson & Johnson’s scientific chief and Vice President Paul said. Stoffels, managing director, said in a statement Thursday.

After the vaccine is approved, it is ‘ready to start shipping’, Stoffels said the company, in collaboration with health authorities around the world, ‘is working very urgently to make our research vaccine available to the public as soon as possible.’

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Johnson & Johnson earlier said they expect to deliver 100 million doses to the US by June.

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If approved, the vaccine is expected to remain stable for two years at -4 degrees Fahrenheit, or -20 degrees Celsius, and in most standard refrigerators for at least three months at temperatures of 36 to 46 ° F.

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This December 2, 2020 photo provided by Johnson & Johnson shows vials containing the Janssen COVID-19 vaccine in the United States. On Thursday, February 4, 2021, Johnson & Johnson asked US regulators to clean up the world’s first COVID-19 vacuum

The efficacy of the J&J vaccine varies from country to country. Although it was 72% domestically effective, the number dropped to 66% in Latin America and 57% in South Africa, where a new, highly contagious strain called B.1.351 spread rapidly.

The first U.S. cases of the B.1.351 variant were identified in South Carolina earlier this month.

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Janssen, the company’s pharmaceutical subsidiary, intends to distribute vaccine doses under federal government immediately after FDA approval, and expects to deliver 100 million doses in the United States during the first half of 2021.

The Department of Health and Human Services announced in August that it had reached an agreement with Janssen to buy 100 million doses for $ 1 billion. The agreement gives the government the option to buy an additional dose of 200 million.

The U.S. Centers for Disease Control and Prevention reported Thursday that more than 35.2 million doses of vaccines have been administered to date. According to Johns Hopkins University, the coronavirus has infected more than 26.6 million Americans and killed more than 455,000 Americans since the pandemic began.

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