The U.S. government on Saturday authorised Johnson & Johnson’s single-dose COVID-19 vaccine, enabling millions more Americans to be vaccinated in the coming weeks and setting it up for additional approvals around the world.
The U.S. Food and Drug Administration announced the emergency use authorisation for adults aged 18 and older following Friday’s unanimous endorsement by the agency’s panel of outside experts.
“The authorisation of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” Acting FDA Commissioner Janet Woodcock said in a statement.
In J&J’s 44 000-person global trial, the vaccine was found to be 66 per cent effective at preventing moderate-to-severe COVID-19 four weeks after inoculation, and 100 per cent effective in preventing hospitalisation and death due to the virus.
There were very few serious side effects reported in the trial, which also offered some preliminary evidence that the vaccine reduced asymptomatic infections.
However, more study is expected, and the FDA on Sunday dismissed the idea that evidence proved the vaccine prevented transmission between people and added there was no data to determine how long the vaccine’s protection lasted.
J&J’s vaccine is expected to be used widely around the globe because it can be shipped and stored at normal refrigerator temperatures, making distribution easier than for the Pfizer Inc/BioNTech SE and Moderna Inc vaccines, which are shipped frozen.
The U.S. government, which has purchased 100 million doses of the J&J vaccine, plans to distribute about 3 million to 4 million this week. That would be on top of the around 16 million doses of the Pfizer/BioNTech and Moderna vaccines it already planned to ship across the country.
J&J plans to provide a total of 20 million doses by the end of March, which along with the more than 220 million total doses expected from Pfizer and Moderna would be enough to fully vaccinate 130 million people in the United States.
So far, the United States has distributed more than 90 million doses of COVID-19 vaccines, some of which have been used for second shots. About 14 per cent of Americans have received at least one dose, according to U.S. government data.
COVID-19 has claimed more than half a million lives in the United States and states are clamoring for more doses to stem cases, hospitalisations, and deaths.
Public health officials have warned about a rise in the prevalence of more contagious variants of the virus, adding to the urgency to get millions more people vaccinated as quickly as possible. Meanwhile, they said, mask wearing and other measures to curb the virus spread should remain in place as recent declines in COVID-19 cases appear to be leveling off.
The J&J vaccine is also under review by the European Union, where deliveries are expected starting in April and would build on the region’s thin supplies of the Pfizer/BioNTech, Moderna and AstraZeneca Plc shots. (Reuters)