U.S. Approves Johnson & Johnson’s COVID-19 Vaccine

© Reuters. Vials of Johnson & Johnson’s Janssen Coronavirus Disease (COVID-19) vaccine candidate are shown in an undated photo

By Julie Steenhuysen

(Reuters) – The U.S. government on Saturday approved the Johnson & Johnson (NYSE 🙂 single-dose vaccine COVID-19, which will vaccinate millions more Americans and set them up for further approvals around the world in the coming weeks.

The U.S. Food and Drug Administration announced emergency approval for adults aged 18 and over after unanimously approved by the agency’s external group of experts on Friday.

“The approval of this vaccine expands the availability of vaccines, the best medical prevention tool for COVID-19, to help us fight this pandemic that has killed over half a million people in the United States,” said the acting FDA Commissioner Janet Woodcock said in a statement.

In J & J’s 44,000-person study, the vaccine was found to be 66% effective in preventing moderate to severe COVID-19 and 100% in preventing hospitalizations and deaths from the virus, four weeks after inoculation is.

Very few serious side effects were reported in the study, which also provided some preliminary evidence that the vaccine reduced asymptomatic infections.

More studies are awaited, however, and the FDA on Sunday rejected the idea that there was evidence that the vaccine prevented transmission between people, adding that there was no data that could determine how long the protection would last Vaccine lasted.

J & J’s vaccine is expected to be widely used around the world as it can be shipped and stored at normal refrigerator temperatures, making it easier to distribute than for the Pfizer (NYSE 🙂 Inc / BioNTech SE and Modern (NASDAQ 🙂 Inc vaccines that are shipped frozen.

“It could potentially play a very important role if we have enough doses as it is only a single dose vaccine and this is attractive to people who are difficult to reach,” said Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical Center in Nashville. “It’s one and it’s done.”

Schaffner said the fact that the J&J vaccine can be stored at normal refrigerated temperatures makes distribution easier. “We can get the vaccine to people,” he said.

The U.S. government, which bought 100 million doses of the J&J vaccine, plans to hand out around 3-4 million this week. This is on top of the roughly 16 million doses of the Pfizer / BioNTech and Moderna vaccines that were already planned for nationwide shipping.

J&J plans to deliver a total of 20 million doses by the end of March, which, along with the more than 220 million total doses expected by Pfizer and Moderna, would be enough to fully vaccinate 130 million people in the United States.

To date, the U.S. has distributed more than 90 million doses of COVID-19 vaccines, some of which have been used for second shots. About 14% of Americans have received at least one dose, according to the US government.

COVID-19 has claimed more than half a million lives in the U.S. and states are calling for more doses to help curb cases, hospitalizations, and deaths.

Public health officials have warned of an increase in the spread of more contagious variants of the virus, adding to the urgency to get millions more people vaccinated as soon as possible. In the meantime, wearing masks and other measures to contain the spread of the virus should persist as recent declines in COVID-19 cases level off.

The J&J vaccine is also under review by the European Union, where delivery is expected in April and would build on the low shipments from Pfizer / BioNTech, Moderna and AstraZeneca (NASDAQ 🙂 Plc recordings in the region.

In South Africa, regulators have been waiting for the FDA’s decision as their government wants to use more J&J vaccines against a variant of the virus called B.1.351 that can elude some vaccine protection.

J & J’s vaccine is being rolled out to about 500,000 healthcare workers there ahead of official approval as it tries to contain infections from the variant that has spread across the country and spread around the world, including the United States.

The vaccine is one of the few that has been tested against the variant in clinical trials and has a 64% rate of effectiveness in preventing moderate to severe diseases in South Africa.

J&J announced on Friday that the company is developing a second generation vaccine that will target the South African variant in question and will be ready to begin Phase I trials by the summer.

J & J’s vaccine uses a cold virus known as adenovirus type 26 to introduce coronavirus proteins into cells in the body and trigger an immune response.

Both the Pfizer and Moderna vaccines, which are based on the new messenger RNA technology, showed higher rates of effectiveness in their pivotal studies when tested at two doses compared to J & J’s single-shot vaccine. However, experts cautioned against close comparisons because the trials had different goals and J & Js were conducted while the more contagious new variants of the virus were floating around.

J&J is testing a two-dose version of its vaccine. The results are expected this summer.

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