BRUSSELS – Johnson & Johnson said on Tuesday it would resume deployment of its coronavirus vaccine in Europe after the European Union’s pharmaceutical regulator said a warning should be added to the product indicating a possible link to clots blood rare, but the benefits of the shot outweigh the risks.
The company decided to delay distribution to the bloc’s 27 member states last week, after regulators in the United States suspended use of the vaccine in that country over concerns about potential side effects.
The approval of the European medicines regulator – even with the caveat – not only paves the way for Johnson & Johnson in Europe, but could portend how the United States will handle the vaccine in the days to come.
On Friday, an advisory group to the Centers for Disease Control and Prevention is due to meet a second time to decide whether to recommend lifting a “pause” on vaccine use in the United States, possibly with a similar warning.
That would free up millions of doses for a country still waging a fierce battle against the pandemic and where nearly eight million Americans have already received the Johnson & Johnson vaccine.
But some health experts fear the headline-grabbing hiatus, which began over a week ago, may discourage some people from getting vaccinated, even though the risks from Covid-19 are far greater. important than the risk of a clot.
“You put a scarlet letter on the Johnson & Johnson vaccine,” said Dr. Paul A. Offit, a vaccine expert at Children’s Hospital in Philadelphia.
After clotting problems associated with another vaccine, produced by AstraZeneca, were reported in Europe, Dr Offit noted, some became wary of it, overestimating the threat. For the Johnson & Johnson vaccine, the risk of a clot has been estimated at one in a million.
“If you take a theoretical million people infected with Covid, five thousand will die,” Dr Offit said. “Therefore, the benefits of this vaccine clearly outweigh its risks.”
A loss of confidence in the Johnson & Johnson vaccine can come at a particular cost.
The vaccine has been warmly received by many health workers because it only requires one injection, unlike those from Moderna or Pfizer-BioNTech, and is easier to store than some other vaccines. It is particularly useful for hard-to-reach or transient populations.
“There is no doubt in my mind that there are groups for which this vaccine is beneficial,” said Dr Offit, “which means that they are more likely to receive this vaccine than other vaccines, than that. or because of their place of residence. , or because they are at home, or because it is difficult to get a second dose.
If that changes, he says, “then you’ve probably elevated a rare risk over a much more common risk, and you’ve done some harm.”
In paving the way for the vaccine’s use, the EU’s medicines regulator, the European Medicines Agency, said the blood clots, which have been reported in a very small group of people, are “very similar To those associated with the AstraZeneca vaccine.
The EMA’s recommendation is not binding, but it is the first indication of what could happen next with the European deployment of the Johnson & Johnson vaccine.
The agency said authorities in EU member states should decide how to proceed, taking into account their particular case load and vaccine availability. Poland is the only country in the EU to have defied company guidelines and administered certain doses of Johnson & Johnson in the past week.
All of the rare cases of blood clots examined by the European regulator have been reported in the United States, but the agency followed through on its recommendations on Tuesday before U.S. regulators took action.
Europe has come here before.
In early March, regulators began receiving reports of rare blood clots in Europeans who had been vaccinated with the AstraZeneca vaccine, which was widely used on the continent. European and national regulators then endeavored to interpret and respond to the results.
The EU regulator said he moved faster to give the Johnson & Johnson vaccine the green light than US officials because, after spending the past two months examining AstraZeneca’s problems, he had acquired a some confidence in the way to react.
In a statement, the agency stressed the importance of addressing the potential side effect and released guidelines for healthcare professionals on the lookout for the rare bleeding disorder. It lists symptoms to look out for, including shortness of breath, chest pain, swelling in the legs, persistent abdominal pain, severe and persistent headache or blurred vision and tiny spots of blood under the skin.
The temporary suspension of Johnson & Johnson’s deployment in the European Union had added to the bloc’s vaccine deployment problems, but it was not as hard a blow as AstraZeneca’s problems.
- On April 13, 2021, U.S. health agencies called for an immediate halt in the use of Johnson & Johnson’s single-dose Covid-19 vaccine after six recipients in the United States developed a rare disease involving blood clots in one to three weeks after vaccination.
- All 50 states, Washington DC and Puerto Rico has temporarily discontinued or recommended health care providers to suspend use of the vaccine. The U.S. military, federally run vaccination sites and a host of private companies including CVS, Walgreens, Rite Aid, Walmart and Publix have also suspended injections.
- Less than one in a million Johnson & Johnson vaccines is currently under investigation. If there is indeed a risk of blood clots from the vaccine – which remains to be determined – this risk is extremely low. The risk of contracting Covid-19 in the United States is much higher.
- The hiatus could complicate the country’s vaccination efforts at a time when many states face an outbreak of new cases and seek to address the reluctance to vaccinate.
- Johnson & Johnson had also decided to delay the rollout of its vaccine in Europe due to concerns over rare blood clots, but then decided to resume its campaign after the European Union’s pharmaceutical regulator said a label warning should be added. South Africa, devastated by a more contagious viral variant that has emerged there, has suspended use of the vaccine and Australia has announced it will not buy any doses.
Vaccination efforts have been delayed in Europe in part because AstraZeneca, an Anglo-Swedish pharmaceutical company that is a major component of the region’s inoculation efforts, was unable to deliver the number of doses scheduled for the first quarter of the year. Then her vaccine was put on hold due to blood clotting issues.
Even though authorities ultimately said the benefits of the AstraZeneca vaccine outweighed the risks and advised EU members to use it, the damage was done.
Many Europeans have refused to take it and several EU countries have limited its use to the elderly, as most people with rare clots are under 60 years old.
Faced with supply shortages after the disruptions at AstraZeneca and Johnson & Johnson, the European Union announced last week that it was increasing its supply of Pfizer-BioNTech vaccine and negotiating a new agreement for future recalls with the company for 2022 and 2023.
But if the impact for Europe can be cushioned, that could be a different story elsewhere. The Johnson & Johnson vaccine has been an important part of immunization plans for countries around the world.
While it has yet to be rolled out on a scale close to AstraZeneca’s, some regions have tipped into the coup amid AstraZeneca’s shortages. The African Union recently acquired 400 million doses.
The break on Johnson & Johnson vaccinations in the United States, as well as new restrictions on the use of the AstraZeneca vaccine in Europe, have rocked vaccination campaigns around the world that rely on these vaccines. South Africa has followed the United States to suspend the Johnson & Johnson firing, although its health regulator has recommended in recent days that its use be resumed.
U.S. health officials have called for a break in vaccine use on April 13. Johnson & Johnson suspended its deployment in the EU immediately thereafter, just as the first shipments of the vaccine were arriving in the region.
Regulators and scientists in the United States are still studying the original reports of the bleeding disorder and scrutinizing any new safety reports on possible cases of the bleeding disorder. So far, this effort has hardly succeeded.
CDC director Dr Rochelle P. Walensky said Monday that health officials were investigating “a handful” of new, unconfirmed reports that emerged after the recess recommendation, to determine if they were. of rare blood clotting disorder.
“Right now we are encouraged that it was not an overwhelming number of cases, but we are watching and seeing what happened,” she said at a press conference at the White House.
Carl Zimmer contribution to the New Haven reports; Noah weiland and Sharon LaFraniere from Washington; and Benjamin mueller from London.