E.U. Approves AstraZeneca Vaccine and Limits Exports

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“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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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.

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.

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.



Source : Nytimes