US approves Johnson & Johnson jab

NEW YORK • The United States government has authorised Johnson & Johnson's (J&J) single-dose Covid-19 vaccine, enabling millions more Americans to be vaccinated in the coming weeks and setting the vaccine up for additional approvals around the world.

The J&J vaccine is the third authorised in the US, following ones from Pfizer-BioNTech and Moderna, both of which require two doses.

The US Food and Drug Administration (FDA) announced the emergency use authorisation of the J&J vaccine for adults aged 18 and older on Saturday, following a unanimous endorsement by the agency's panel of outside experts. Shipments to vaccination sites were expected to begin yesterday or today.

President Joe Biden hailed the move but cautioned Americans against celebrating too soon. "Things are still likely to get worse again as new variants spread," he said in a statement, urging people to continue washing their hands, wearing masks and maintaining social distancing.

"There is light at the end of the tunnel, but we cannot let our guard down now or assume that victory is inevitable," he said.

Both the Pfizer and Moderna vaccines, which are based on new messenger RNA technology, showed higher efficacy rates in pivotal trials that used two doses versus J&J's single-shot vaccine.

While J&J's vaccine is a single shot, Pfizer-BioNTech and Moderna vaccines each require two shots three or four weeks apart.

Direct comparison, however, is difficult because the trials had different goals and J&J's was conducted while more contagious new variants of the virus were circulating.

Pfizer-BioNTech and Moderna focused on efficacy against mild-to-moderate sickness, while J&J's trial looked for efficacy against moderate-to-severe Covid-19.

All three vaccines have a similar range of short-lived side effects, including fatigue, aches, injection site soreness, nausea and fever, mostly mild to moderate.

Percentage of Americans who have received at least one dose of a Covid-19 vaccine, according to US government data.

"We believe that people should take the vaccine they are able to access," the FDA's acting commissioner, Dr Janet Woodcock, said in a call after the authorisation, noting the three vaccines had not been studied head-to-head.

"We feel that each of these vaccines will be effective, will prevent hospitalisation, deaths and should be used," she said.

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. It was 100 per cent effective in preventing hospitalisation and death due to the virus.

Meanwhile, Pfizer-BioNTech and Moderna vaccines showed efficacy of around 95 per cent in preventing illness in large trials.

There were very few serious side effects reported in J&J's trial, which also offered preliminary evidence that the vaccine reduced asymptomatic infections.

More study is expected. The FDA on Saturday 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-BioNTech and Moderna vaccines, which must be shipped frozen.

"It potentially could play a very substantial role if we have enough doses because it's only a single-dose vaccine and that will make it attractive to people who are difficult to reach," said Dr William Schaffner, an infectious disease expert at Vanderbilt University Medical Centre in Nashville. "It's one and done."

The US government, which has purchased 100 million doses of the J&J vaccine, plans to distribute about three million to four million next week. That would be on top of the around 16 million doses of the Pfizer-BioNTech and Moderna vaccines the government already planned to ship across the country.

"We are ready to roll it out," White House senior adviser Andy Slavitt wrote on Twitter after the authorisation.

J&J said it had begun shipping vaccines to the government.

It plans to provide a total of 20 million doses by the end of this month, which along with the more than 220 million total doses expected from Pfizer and Moderna would be enough to fully vaccinate 130 million Americans.

So far, the US 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 US government data.

Covid-19 has claimed more than half a million lives in the US, and states are clamouring 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.

The J&J vaccine is also under review by the European Union, where deliveries are expected starting next month and would build on the region's thin supplies of the Pfizer-BioNTech, Moderna and AstraZeneca shots.

REUTERS