The U.S. government on Saturday approved the Johnson & Johnson COVID-19 single-dose vaccine, allowing millions more Americans to be vaccinated in the coming weeks and set aside for additional licenses. all over the world.
The U.S. Food and Drug Administration named the emergency use authority for adults ages 18 and older following a unanimous agreement Friday with a panel of experts outside the organization. Shipping is expected to start on Sunday or Monday.
U.S. President Joe Biden said he moved but warned Americans not to signal too early. “Things are still likely to get worse as new versions roll out,” he said in a statement, urging people to continue washing their hands, wearing masks, and keeping social distance.
“There is a light at the end of the tunnel, but we cannot let down our guard now or accept that there is an inevitable impact,” he said.
In a 44,000-person J&J global trial, the vaccine was found to be 66% effective in preventing moderate-to-severe COVID-19 four weeks after vaccination, and 100% effective in preventing prevention of hospitalization and death due to the virus.
Very few adverse effects were reported in the trial, which also provided some preliminary evidence that the vaccine reduced asymptomatic diseases.
However, more investigation is expected, and the FDA on Sunday dismissed the view that evidence confirmed that the vaccine prevented human-to-human transmission and said there were no data to determine how long the vaccine’s protection lasted. .
The J&J vaccine is expected to be widely used worldwide as it can be disposed of and stored at normal cooling temperatures, making circulation easier than for the Pfizer Inc / BioNTech SE and Moderna vaccines. Inc., which are frozen.
“It could take a huge role if we have enough doses because it’s just a one-dose vaccine and that will make it attractive to hard-to-reach people,” said Dr William Schaffner, an infectious disease specialist at Vanderbilt University Medical Center in Nashville. “It’s one and done.”
Schaffner said it will be easier to circulate if the J&J vaccine is stored at normal cooling temperatures.
The U.S. government, which bought 100 million doses of the J&J vaccine, plans to distribute about 3 million to 4 million this week. That would be in addition to the approximately 16 million doses of the Pfizer / BioNTech and Moderna vaccines they had already planned to roll out nationwide.
“We’re ready to roll it out,” White House Chief Adviser Andy Slavitt wrote on Twitter after the authorization.
J&J expects to deliver 20 million doses by the end of March, which together with the more than 220 million total doses expected from Pfizer and Moderna would be enough to vaccinate 130 million people in the United States.
To date, the United States has dispensed more than 90 million doses of COVID-19 vaccines, some of which have been used for second sight. About 14% of Americans have received at least one dose, according to U.S. government data.
COVID-19 has claimed that more than half a million lives in the United States and states are screaming for more doses to prevent cases, hospitalizations, and deaths.
Public health officials have warned of an increase in more infectious numbers of the virus, adding to the urgency for millions more people to be vaccinated as soon as possible. At the same time, they said, mask wear and other measures to prevent the spread of the virus should remain as the recent decline in COVID-19 cases seems to be smooth.
The J&J vaccine is also under review with the European Union, where delivery is expected to begin in April and would build on the region ‘s thin supply of Pfizer / BioNTech, Moderna and AstraZeneca Plc images.
In South Africa, regulators were awaiting an FDA decision as their government is looking at more J&J vaccines against a variant of the virus called B.1.351 that may have some protection avoid vaccination.
The J&J vaccine is being distributed there before receiving official approval for about 500,000 health care workers as they try to eradicate infections from the variant, which has swept across the country. country and spread across the globe, including the United States.
The vaccine is one of the few that has been tested in clinical trials against the variant and had a 64% efficacy rate in preventing moderate to severe disease in South Africa.
J&J said on Friday that the company was developing a second-generation vaccine that would target the South African difference and be ready to begin Phase I testing before this summer.
The J&J vaccine uses a common cold virus called adenovirus type 26 to inject coronavirus proteins into cells in the body and to stimulate an immune response.
Both the Pfizer and Moderna vaccines, which are based on new messenger RNA technology, showed higher levels of efficacy in their critical trials when the trial used two doses against the J & J single-vaccine vaccine. warning against close comparison because the tests had different goals and J&J was done while the newer, more infectious versions of the virus were circulating.
J&J is testing a two-dose version of its vaccine, with results expected this summer.
(Reuters)