Johnson & Johnson to Resume European Union Vaccine Rollout

BRUSSELS – Johnson & Johnson announced Tuesday that it would resume rollout of its coronavirus vaccine in Europe after the European Union Medicines Agency announced it would add a warning to the product highlighting a possible association with rare blood clots that The benefits of the shot, however, outweigh the risks.

The company decided last week to postpone distribution in the bloc’s 27 member states after regulators in the US suspended use of the vaccine there due to concerns about possible side effects.

The approval of the EU drug regulator – also with the caveat – not only paves the way for Johnson & Johnson in Europe, but could also predict how the US will deal with the vaccine in the coming days.

An advisory panel from the Centers for Disease Control and Prevention is due to meet for the second time on Friday to decide whether to recommend a “break” in vaccine use in the US, possibly with a similar warning.

That would free millions of doses for a country still fighting the fierce battle against the pandemic, where nearly eight million Americans have already received the Johnson & Johnson vaccine.

However, some health professionals fear that the headline hiatus that began over a week ago could discourage some people from getting vaccinated, even though the risks of Covid-19 are far greater than the risk of a blood clot.

“You wrote a scarlet letter about the Johnson & Johnson vaccine,” said Dr. Paul A. Offit, vaccine expert at Philadelphia Children’s Hospital.

After coagulation concerns were reported in Europe related to another vaccine manufactured by AstraZeneca, Dr. Offit notes that some have become suspicious and overestimated the threat. For the Johnson & Johnson vaccine, the risk of a clot has been estimated to be one in a million.

“If you take a theoretical million people infected with Covid, five thousand will die,” said Dr. Offit. “Therefore, the benefits of this vaccine clearly outweigh the risks.”

Loss of confidence in the Johnson & Johnson vaccine can be costly.

The vaccine has been warmly welcomed by many health workers because, unlike those from Moderna or Pfizer-BioNTech, it only takes a single shot and is easier to store than some other vaccines. It’s especially useful for hard-to-reach or temporary populations.

“I have no doubt that there are groups that will benefit from this vaccine,” said Dr. Offit or because they are attached to their homeland or it is difficult to get a second dose. “

If that changes, he said, “Then you’ve probably increased a rare risk over a much more common risk, and you’ve done harm.”

The EU Medicines Agency, the European Medicines Agency, paved the way for the vaccine to be used, saying the blood clots reported in a very small group of people were “very similar” to those of the AstraZeneca vaccine.

The EMA’s recommendation is not binding, but it is the first indication of what might happen next with the European launch of the Johnson & Johnson vaccine.

Updated

April 21, 2021, 8:58 p.m. ET

The agency said that authorities in individual EU member states should decide how to proceed, taking into account their particular case load and the availability of vaccines. Poland is the only EU country that defied the company’s guidelines and administered a few Johnson & Johnson doses over the past week.

All rare blood clot cases reviewed by the European regulator have been reported in the United States, but the agency continued its recommendations Tuesday before US regulators acted.

Europe has been here before.

In early March, regulators received reports of rare blood clots in Europeans vaccinated with the AstraZeneca shot, which is widely used across the continent. The EU and national regulators then tried to interpret the results and act on them.

The EU regulator said it had given the Johnson & Johnson vaccine the green light sooner than US authorities because it had built some confidence in the response after reviewing the AstraZeneca issues over the past two months.

In a statement, the agency stressed the importance of managing the possible side effects and issued guidelines for health professionals to look out for the rare coagulation disorder. Symptoms to look out for were listed, including shortness of breath, chest pain, leg swelling, 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 rollout in the European Union had contributed to the block’s vaccine launch problems, but was not as bad a blow as the AstraZeneca problems.

What You Need To Know About The Johnson & Johnson Vaccine Break In The United States

    • On April 13, 2021, U.S. health officials called for an immediate halt to use of Johnson & Johnson’s single-dose Covid-19 vaccine after six recipients in the U.S. developed a rare blood clot disorder within one to three weeks of being vaccinated.
    • All 50 states, Washington, DC, and Puerto Rico have temporarily stopped using the vaccine or recommended providers are suspending use of the vaccine. The U.S. military, government-run vaccination centers, and a variety of private companies, including CVS, Walgreens, Rite Aid, Walmart, and Publix, also paused the injections.
    • Fewer than one in a million Johnson & Johnson vaccinations are currently being studied. If there is indeed a risk of blood clots from the vaccine – which has yet to be determined – the risk is extremely small. 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 are facing spikes in new cases and are trying to address vaccine hesitation.
    • Johnson & Johnson had also decided to delay the launch of its vaccine in Europe amid concerns about rare blood clots. However, the company later decided to continue its campaign after the European Union Medicines Agency announced the addition of a warning notice. South Africa, devastated by a contagious variant of the virus, stopped using the vaccine and Australia announced it would not buy doses.

Vaccination efforts in Europe have fallen back in part because AstraZeneca, a British-Swedish pharmaceutical company that is a key part of the region’s vaccination effort, was unable to deliver the number of doses expected in the first quarter of the year. Then his vaccine was suspended because of blood clotting problems.

Although authorities eventually stated that the benefits of the AstraZeneca vaccine outweighed the risks and advised EU members to use it, the damage had been done.

Many Europeans have refused to take it and several EU countries have restricted its use to the elderly as most of the people who had the rare blood clots were under the age of 60.

In light of supply shortages following the disruptions at AstraZeneca and Johnson & Johnson, the European Union announced last week it would increase its range of Pfizer BioNTech vaccines and negotiated a new contract with the company for future booster vaccines for 2022 and 2023.

While the impact on Europe may be cushioned, it could be a different story elsewhere. The Johnson & Johnson vaccine has been an important part of vaccination schedules for countries around the world.

While it hasn’t been launched on the order of AstraZeneca yet, some regions have focused on the shot given the AstraZeneca bottlenecks. The African Union recently purchased 400 million cans.

The hiatus in Johnson & Johnson vaccinations in the US, as well as new restrictions on the use of AstraZeneca’s shot in Europe, have rocked vaccination campaigns around the world that relied on these vaccines. South Africa followed the United States to suspend Johnson & Johnson’s shooting despite its health agency recommending resumption in recent days.

U.S. health officials on April 13th called for a break in vaccine use. Johnson & Johnson suspended the EU rollout immediately after the first shipments of the shot arrived in the region.

US regulators and scientists are still investigating the original reports of the coagulation disorder and sifting through new safety reports on possible cases of the coagulation disorder. Little of these efforts has surfaced so far.

Dr. Rochelle P. Walensky, the CDC director, said Monday that health officials are investigating “a handful” of new, unconfirmed reports released after the hiatus was recommended to see if they might be cases of the rare blood clotting disorder.

“Right now we’re encouraged that it hasn’t been an overwhelming number of cases, but we’ll look and see what has come in,” she said at a White House press conference.

Carl Zimmer contributed to the coverage of New Haven; Noah Weiland and Sharon LaFraniere from Washington; and Benjamin Mueller from London.