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US officials are investigating reports of blood clots in six women who were given the J&J Covid-19 vaccine. Photo: Reuters

Coronavirus: Johnson & Johnson vaccine halted in US, roll-out delayed in Europe

  • Reports of rare but potentially dangerous blood clots investigated
  • Pause a setback to the global vaccination campaign
The pause in the roll-out of Johnson & Johnson’s Covid-19 vaccine marks another setback for the world’s inoculation campaign, just as it was picking up speed in Europe and other regions where immunisations have lagged.

The drug maker suspended shots in Europe after US officials urged pausing vaccinations to review rare cases of deadly brain clots, similar to those seen with AstraZeneca’s vaccine. Several countries in Asia were on the verge of deciding whether to approve J&J’s inoculation before the safety issue arose, while Australia had already ruled out any purchases.

In the European Union, which is struggling to quell a fresh wave of the pandemic, the suspension came as the bloc was finally accelerating vaccinations after trailing far behind the US and UK.

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The stakes are higher for poorer countries reliant on Covax, a vaccine-access initiative backed by the World Health Organization. The group has an advance purchase agreement for as many as 500 million doses of the J&J shot. The African Union signed a deal last month for 400 million doses this year and next, with deliveries set to start in the third quarter.

At a briefing on Tuesday, FDA officials said the length of the pause will depend on what they learn, but they expect it to be a “matter of days”.

While the J&J shot hasn’t been widely used in Asia, that was poised to change. Most places in the region didn’t needed vaccinations to protect against the virus since strict social distancing and other mitigation measures kept it firmly in check. The immunisations were critical, however, for reopening to the broader world.

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Regulators in New Zealand were slated to decide on the vaccine, and said they would take the latest information into account. The Philippines was expected to sign with J&J this week, while Thailand approved it for emergency use on March 25. India, facing a mounting outbreak, has said it would fast track approvals of shots that other countries cleared, including the one from J&J.

South Korea, which granted the company conditional approval last week and has placed the largest order in the region for it, said it would monitor the US suspension and track the shot’s safety. It isn’t expecting shipments until the third quarter. Japan also said it’s gathering information on J&J’s vaccine.

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The safety setback could delay delivery of one billion doses of vaccine designated for the region by 2022. The immunisations were pledged at a meeting last month of the “Quad”, made up of the leaders of the US, India, Japan and Australia.

The European Medicines Agency said it isn’t clear whether there’s a causal link between the J&J vaccine and the clotting disorder. It began a review of the cases last week and will say more once it finishes the evaluation. About 6.8 million people in the US have received the J&J shot.

The EMA was watching developments closely and was in contact with the FDA, EU Health Commissioner Stella Kyriakides said.

After examining the rare cases of clotting in those who received the AstraZeneca shot, the EMA warned last week of a link but said that the vaccine’s benefits still outweigh its risks.

EU countries had expected deliveries of some 55 million J&J doses this quarter. Shortly before the US news, Italy’s pandemic emergency tsar General Francesco Paolo Figliuolo had hailed the imminent arrival of the first batch.

Italy and other EU countries would now hold onto their doses and use other vaccines until the FDA gives the green light on the J&J shot, according to people familiar with the plans, who asked not to be identified because the discussions aren’t public.

The optics could hardly be worse for EU nations: the arrival of a new vaccine undermined by concerns similar to those that are prompting some Europeans to shun AstraZeneca’s shot. Some EU countries are limiting the Astra vaccine to older people.

The vaccine is under review in the UK but hasn’t been approved there yet. The Medicines and Healthcare products Regulatory Agency will evaluate safety reports before making a decision, Siu Ping Lam, director of licensing, said.

The J&J vaccine, like the one developed by Astra and the University of Oxford, uses an adenovirus to deliver the genetic material into the body to provoke a defence against Covid-19. The Oxford-Astra vaccine uses a chimpanzee adenovirus to achieve the response, while J&J’s is derived from humans. Russia’s Sputnik V vaccine and one from China’s CanSino Biologics also rely on that approach.

The clot question has left some buyers wary of adenovirus vaccines altogether. On Tuesday, Australia said it wouldn’t purchase any more of that type of Covid-19 shot, ending talks with J&J over a procurement deal.

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