US approves resumption of Johnson & Johnson’s Covid-19 vaccine

24 / 04 / 2021

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US regulators have recommended healthcare providers resume using Johnson & Johnson’s Covid-19 vaccine after concluding the benefits outweighed the risks of serious blood clotting issues.

The country’s Food and Drug Administration and Centers for Disease Control and Prevention said on Friday night that they were lifting the recommended pause they announced 10 days ago after six people became seriously ill within days of receiving the vaccine.

Regulators said the pause was necessary to evaluate the medical evidence and warn doctors about potential problems, especially for women aged under 50. The pause knocked public confidence in the company’s vaccine, however, and appears to have helped to trigger a slowdown in the pace of America’s vaccination programme.

Rochelle Walensky, director of the CDC, said: “The American public should feel reassured about the safety systems and protocols that we have been placed around the Covid-19 vaccine. Our systems helped identify incredibly rare events.”

Asked whether younger women should get the J&J vaccine, Walensky replied: “I think that this risk trade-off is one that people have to individually measure for themselves . . . this should be certainly an option for women in that age category.”

The announcement came after an external panel of scientific advisers said they believed J&J’s vaccinations should resume for everyone aged over 18, albeit with an additional FDA warning.

The Advisory Committee on Immunization Practices voted 10-4 on Friday to recommend lifting a pause it called for 10 days ago, after six out of the more than 7m people who received the vaccine fell seriously ill. Since then another nine cases have been reported, all in women, three of whom have died.

While the FDA has decided there is a “plausible” link between the vaccine and the illnesses, members of ACIP recommended that its use should be resumed with a new warning from the regulator. The final decision on whether to administer the vaccine will be taken by US states and healthcare providers. The pause was put in place after several women fell ill with a combination of blood clots and low platelet counts. Such a combination is very rare, doctors said, and may be exacerbated by using a traditional anticoagulant to treat blood clots. All of the women were under the age of 60, and most were between the age of 34 and 40. But the CDC found that the benefits of receiving the vaccine outweighed the risks for every group they analysed, including women under the age of 50.

According to the CDC analysis, recommending the J&J vaccine for everyone aged 18 and over would prevent up to 1,400 deaths over a six-month period. The organisation also found it would bring forward by two weeks the point at which every US adult who wanted a vaccine would have one.

J&J said it had agreed a new label with the FDA, which would warn that “adverse events” had been reported after using the vaccine, most of which had occurred in women from 18 to 49 years old. Several members of the committee said they wanted a stronger warning, for younger women in particular. Sarah Long, professor of paediatrics at Drexel University College of Medicine, said: “This is an age group that is most at risk [from clotting and low platelet counts] that is getting this vaccine predominantly to save other people’s lives, and morbidity, rather than their own.

“I am very sorry that we haven’t chosen to put up front, the knowledge that we have, this is unique, it’s clustered, it’s almost certainly related to the vaccine, and there are options,” she added, referring to supplies of rival vaccines made by BioNTech/Pfizer and Moderna. José Romero, the chair of the committee and director at the Arkansas Department of Health, said doctors would be able to make the risks clear to recipients.

“It is our responsibility as clinicians to make sure that women understand this risk and when possible, that they have an alternative,” he added. The committee met last week, but could not agree whether the single-shot vaccine should still be recommended for universal use in adults.

Earlier this week the European Medicines Agency found there was a “possible link” between the jab and blood clots, but concluded the benefits outweighed the risks.

Germany announced on Friday morning it would allow the vaccine to be given to everyone, but Sweden said it was keeping its suspension in place. Since the start of the pause, the pace of inoculations in the US has dropped from an average of 3.4m a day to 2.9m a day.

The country has administered 219m doses, according to the CDC, with just over half of all adults having received at least one dose. A similar issue with rare blood clots has disrupted the rollout of the Oxford/AstraZeneca vaccine, which, like J&J’s jab, uses an adenovirus, such as the common cold, to deliver the vaccine protein into the body. The vaccines developed by BioNTech/Pfizer and Moderna use messenger RNA technology.

J&J’s vaccine, the first single-shot jab authorised for use in the US, has faced other setbacks. Production of the vaccine at a plant in Baltimore was halted by the FDA earlier this week while the agency investigates the site, run by Emergent BioSolutions, which has been beset by manufacturing problems.

The House of Representatives committee on oversight and reform on Monday launched a separate investigation into whether Emergent received contracts to manufacture vaccines “despite a long, documented history of inadequately trained staff and quality control issues”.