Experts recommend authorisation of Johnson & Johnson’s one-dose Covid-19 vaccine

A panel of expert advisers to the US Food and Drug Administration on Friday voted to recommend authorisation of Johnson & Johnson's one-dose Covid-19 vaccine for emergency use, bringing it an important step closer to a US rollout.

The FDA is likely to authorise the vaccine for emergency use within a day or so, making it the third available in the United States, and the only one that requires a single shot. The panel consisting of doctors, infectious disease experts and medical researchers voted unanimously that the benefits of the vaccine outweigh its risks in people age 18 and over.

“We believe our Covid-19 vaccine candidate has the potential to help change the trajectory of the pandemic and stand ready to make it available to protect the public as soon as possible,” Dr Paul Stoffels, J&J’s chief scientific officer said in a statement.

The company said it is prepared to supply its vaccine immediately if it receives emergency use authorisation (EUA), as expected.

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J&J has said it will be able to ship three million to four million doses of its vaccine next week. The company expects to have enough supply to vaccinate 20 million people by the end of March.

Senior White House adviser Andy Slavitt tweeted that the FDA would meet to finalise the EUA on Saturday. “A third safe and effective vaccine is very welcome news,” he said.

Vaccine shots

More than 50 million vaccine shots have been administered nationwide, a milestone highlighted by President Joe Biden on Thursday. But the emergence of highly contagious new virus variants has only enhanced the urgency to get hundreds of millions more people inoculated against a virus that has claimed the lives of more than a half a million people in the United States.

Panel member Jay Portnoy, professor of pediatrics at the University of Missouri-Kansas City School of Medicine, said the race was on to stop the pandemic before new virus variants cause further disease. “The fewer people who are infected with the virus, the less opportunity it has to emerge as a more virulent strain. So we’re in a hurry to get this vaccine out,” he said.

The head of the US Centers for Disease Control and Prevention on Friday expressed concern that a recent decline in US Covid-19 cases may be stalling. In a 44,000-person trial, the J&J vaccine overall was 66 per cent effective at preventing moderate-to-severe cases of Covid-19 compared with a placebo. Two-dose vaccines made by Pfizer with BioNTech SE and Moderna were about 95 per cent effective in their pivotal trials.

Experts cautioned against drawing too much of a distinction between the vaccines because the trials had somewhat different goals, and importantly, the Pfizer/BioNtech and Moderna studies were conducted before the more transmissible virus variants had emerged in South Africa, Brazil and the UK.

J&J’s trial was under way when the new variants were circulating and even prevalent in some countries where it was tested. Still, its vaccine was 100 per cent effective at preventing hospitalisations 28 days after vaccination and there were no Covid19 deaths among those who received the shot.

During the meeting, a J&J vaccine executive said the company was developing a second-generation vaccine that would target the concerning South African variant and will be ready to start Phase I trials by this summer. The J&J vaccine can be stored in normal refrigerator temperatures, making distribution easier than for the Pfizer/BioNTech and Moderna shots that use messenger RNA technology and are shipped frozen. J&J's vaccine uses a common cold virus known as adenovirus type 26 to introduce coronavirus proteins into cells in the body and trigger an immune response.

Meanwhile, the European Union’s medicines regulator is set to recommend Johnson & Johnson’s vaccine early next month, bolstering supplies even as governments struggle to get shots into people’s arms.

The European Medicines Agency's (EMA) nod is expected on March 11th, an EU official said, on condition of anonymity. It would clear the way for market authorisation of a fourth Covid-19 vaccine, alongside those from Moderna, AstraZeneca and a partnership of Pfizer and BioNTech.

An EMA spokesman said the agency is working toward issuing an opinion by mid-March but it couldn’t confirm a date.

The EU official also said EMA talks are ongoing with Russian authorities on the Sputnik V vaccine and it may receive data soon to begin a rolling review process.

Deliveries

The European Commission has said deliveries of the J&J shot are expected to begin in early April, adding to a surge in supplies over the second and third quarters. European Commission president Ursula von der Leyen showed a slide to EU leaders during a video summit on Thursday projecting a dramatic increase in vaccine deliveries over the coming months.

The EU’s advance purchase deal with J&J allows member states to purchase vaccines for 200 million people, with an option for another 200 million.

The EMA is also carrying out a rolling review of vaccine candidates from CureVac and Novavax. The commission has struck deals for the initial purchase of 225 million CureVac shots and concluded exploratory talks with Novavax to purchase 100 million doses. – Reuters, Bloomberg, The Financial Times