The bloc authorized use of AstraZeneca’s vaccine, the third it has approved, while battling the company, which it says is shirking its obligations to deliver the shots.
By Matina Stevis-Gridneff
BRUSSELS — Desperate as doses run dry, the European Union on Friday approved its third coronavirus vaccine, while moving to restrict exports of the shot, shunning its decades-old free-trade, anti-protectionism creed amid a growing crisis.
E.U. regulators authorized the shot produced by AstraZeneca, even as the company and the bloc fight over AstraZeneca’s insistence that it cannot deliver as many doses as it had promised, and as the European Union falls well behind Britain and the United States in inoculations.
The export controls came in response to the spat with AstraZeneca, as well as severe shortages at vaccination centers. French and German regions have reported that they have nearly run out of vaccine, and the Madrid region of Spain has suspended its rollout for at least two weeks until fresh deliveries arrive.
Supply chain disruptions have slowed delivery of the two vaccines already in use in the European Union, from Pfizer and Moderna, creating mounting pressure on E.U. leaders to ensure that mass immunization plans stay on track.
“The protection and safety of our citizens is a priority and the challenges we now face have left us with no choice other than to act,” Valdis Dombrovskis, a top European Commission official, said Friday as he announced the export controls approved by the commission, the bloc’s executive branch. “This is a race against the clock. We cannot lose time because of vaccines not being delivered on the agreed schedule.”
The measure, which takes effect on Saturday, is aimed at AstraZeneca and escalates a conflict between the European Union and Britain, which finalized its departure from the bloc just weeks ago. It empowers the Europeans to halt any export of doses manufactured within the bloc unless the maker first meets its supply obligations to the 27 E.U. member states.
AstraZeneca, headquartered in Britain, developed its vaccine in cooperation with the University of Oxford, and is producing it at multiple plants, in Britain and on the continent. Britain authorized use of the vaccine in late December, a month ahead of the bloc, and has been receiving a steady flow of the shots.
The European Union did not make an advance purchase agreement with AstraZeneca until last fall, three months after Britain had signed one, but the bloc paid the company about $400 million to help it scale up production capacity.
AstraZeneca said this month that it would significantly cut its planned February and March deliveries to the European Union, infuriating E.U. officials, who accused the pharmaceutical company of using its promised doses to serve Britain, in bad faith and in breach of the company’s contractual obligations.
The company’s chief executive responded that he regretted the situation, but that his company had not committed to a specific production and delivery schedule, but rather to a vow to make its “best effort.”
The policy announced by the European Commission on Friday, presented as a “transparency tool,” directs pharmaceutical companies manufacturing coronavirus vaccines within the bloc’s borders — currently Pfizer and AstraZeneca — to submit paperwork alerting European authorities of any intention to move their products to non-E.U. countries.
The commission said it reserved the right to block such exports if it determined that the pharmaceutical companies were not meeting their E.U. contractual obligations first. The policy will be in place until the end of March and will not apply to exports intended for poorer countries.
The measure could theoretically also affect Pfizer, but the commission has said it is happy with how that company has handled a supply disruption in its Belgian factory that is setting back deliveries. The company has spread the pain among its customers, which include the E.U., Britain and Canada.
In a news conference on Friday, AstraZeneca’s chief executive, Pascal Soriot, defended his company’s handling of the shortfalls, saying AstraZeneca is “absolutely focused” on accelerating the production and delivery of vaccines for the European Union.
“We’re trying to really catch up, and there’s not much more we can do,” Mr. Soriot said. “The facts are that we have enough quantity that we are delivering starting this month to the European Union, but it is not as much as we would have hoped.”
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Answers to Your Vaccine Questions
Currently more than 150 million people — almost half the population — are eligible to be vaccinated. But each state makes the final decision about who goes first. The nation’s 21 million health care workers and three million residents of long-term care facilities were the first to qualify. In mid-January, federal officials urged all states to open up eligibility to everyone 65 and older and to adults of any age with medical conditions that put them at high risk of becoming seriously ill or dying from Covid-19. Adults in the general population are at the back of the line. If federal and state health officials can clear up bottlenecks in vaccine distribution, everyone 16 and older will become eligible as early as this spring or early summer. The vaccine hasn’t been approved in children, although studies are underway. It may be months before a vaccine is available for anyone under the age of 16. Go to your state health website for up-to-date information on vaccination policies in your area
You should not have to pay anything out of pocket to get the vaccine, although you will be asked for insurance information. If you don’t have insurance, you should still be given the vaccine at no charge. Congress passed legislation this spring that bars insurers from applying any cost sharing, such as a co-payment or deductible. It layered on additional protections barring pharmacies, doctors and hospitals from billing patients, including those who are uninsured. Even so, health experts do worry that patients might stumble into loopholes that leave them vulnerable to surprise bills. This could happen to those who are charged a doctor visit fee along with their vaccine, or Americans who have certain types of health coverage that do not fall under the new rules. If you get your vaccine from a doctor’s office or urgent care clinic, talk to them about potential hidden charges. To be sure you won’t get a surprise bill, the best bet is to get your vaccine at a health department vaccination site or a local pharmacy once the shots become more widely available.
Probably not. The answer depends on a number of factors, including the supply in your area at the time you’re vaccinated. Check your state health department website for more information about the vaccines available in your state. The Pfizer and Moderna vaccines are the only two vaccines currently approved, although a third vaccine from Johnson & Johnson is on the way.
That is to be determined. It’s possible that Covid-19 vaccinations will become an annual event, just like the flu shot. Or it may be that the benefits of the vaccine last longer than a year. We have to wait to see how durable the protection from the vaccines is. To determine this, researchers are going to be tracking vaccinated people to look for “breakthrough cases” — those people who get sick with Covid-19 despite vaccination. That is a sign of weakening protection and will give researchers clues about how long the vaccine lasts. They will also be monitoring levels of antibodies and T cells in the blood of vaccinated people to determine whether and when a booster shot might be needed. It’s conceivable that people may need boosters every few months, once a year or only every few years. It’s just a matter of waiting for the data.
Employers do have the right to compel their workers to be vaccinated once a vaccine is formally approved. Many hospital systems, for example, require annual flu shots. But employees can seek exemptions based on medical reasons or religious beliefs. In such cases, employers are supposed to provide a “reasonable accommodation” — with a coronavirus vaccine, for example, a worker might be allowed to work if they wear a mask, or to work from home.
If you have other questions about the coronavirus vaccine, please read our full F.A.Q.
Mr. Soriot said that AstraZeneca’s first shipment to the European Union of about three million doses would go out in the next few days and that the company would make three shipments to the European Union in February.
The European Commission published a heavily redacted version of its contract with AstraZeneca, which seems to afford the company many protections in case it fails to deliver. But it also includes some clauses that could be seen as favoring the E.U. interpretation that AstraZeneca is obligated to turn to other factories, including those in Britain, to fulfill its expected E.U. deliveries.
The vaccine’s authorization on Friday by the European Medicines Agency added a bit of positive news to the mix. Despite concerns that AstraZeneca’s clinical trials did not include enough older subjects, the agency approved the shot for all age groups, though some member nations may impose an age cap on its use.
On Thursday, Germany’s vaccination advisory committee, which provides recommendations to the country’s government, cautioned against using the AstraZeneca shot on people age 65 and over, saying in a draft report that “there currently is not sufficient data to assess the vaccination effectiveness above 65 years.”
The German Health Ministry, which usually follows the committee’s advice, declined to comment. Britain has been administering AstraZeneca shots to all age groups, even as British regulators have conceded that data on the vaccine’s efficacy and safety “are currently limited” in people age 65 and older. Prime Minister Boris Johnson, during a visit to Scotland on Thursday, insisted that British medicine regulators had determined it to be “effective across all age groups.”
The E.U. regulator said that while there was not enough data for a firm conclusion about vaccine use in older people, “protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines.” Nonetheless the agency’s scientists left the door open for national authorities to choose the Pfizer or Moderna vaccines for older citizens.
“If there are other options, they may be preferred,” said Bruno Sepodes, a top scientist with the agency.
In the United States, the Food and Drug Administration is awaiting data from a clinical trial, which enrolled about 30,000 participants, to be released in the coming weeks, before acting on the AstraZeneca vaccine. The company is expected to have sufficient safety data from that study to file for emergency use authorization from the F.D.A. around the first week of March.
Monika Pronczuk and Rebecca Robbins contributed reporting.
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