Although AstraZeneca vaccine produced in Europe has been authorized by the continent’s drug regulatory agency, the same shot manufactured in India hasn’t been given the green light.
EU regulators said AstraZeneca hasn’t completed the necessary paperwork on the Indian factory, including details on its production practices and quality control standards.
But some experts describe the EU move as discriminatory and unscientific, pointing out that the World Health Organization has inspected and approved the factory. Health officials say the situation won’t only complicate travel and frustrate fragile economies but also undermine vaccine confidence by appearing to label some shots substandard.
As vaccination coverage rises across Europe and other rich countries, authorities anxious to salvage the summer tourism season are increasingly relaxing coronavirus border restrictions.
Earlier this month, the European Union introduced its digital COVID-19 certificate, which allows EU residents to move freely in the 27-nation bloc as long as they have been vaccinated with one of the four shots authorized by the European Medicines Agency, have a fresh negative test, or have proof they recently recovered from the virus.
While the U.S. and Britain remain largely closed to outside visitors, the EU certificate is seen as a potential model for travel in the COVID-19 era and a way to boost economies.
The officially EU-endorsed vaccines also include those made by Pfizer, Moderna and Johnson & Johnson. They don’t include the AstraZeneca shot made in India or many other vaccines used in developing countries, including those manufactured in China and Russia.
Individual EU countries are free to apply their own rules for travelers from inside and outside the bloc, and their rules vary widely, creating further confusion for tourists. Several EU countries, including Belgium, Germany and Switzerland, allow people to enter if they have had non-EU-endorsed vaccines; several others, including France and Italy, don’t.
WHO urged countries to recognize all of the vaccines it has authorized, including two Chinese-made ones. Countries that decline to do so are “undermining confidence in lifesaving vaccines that have already been shown to be safe and effective, affecting uptake of vaccines and potentially putting billions of people at risk,” the U.N. health agency said in a statement this month.
In June, the Serum Institute of India’s CEO, Adar Poonawalla, tweeted that he was concerned about vaccinated Indians facing problems traveling to the EU and said he was raising the problem at the highest levels with regulators and countries.
Stefan De Keersmaeker, a spokesman for the EU’s executive arm, said last week that regulators were obligated to check the production process at the Indian factory.
“We are not trying to create any doubts about this vaccine,” he said.
AstraZeneca said it only recently submitted the paperwork on the Indian factory to the EU drug regulatory agency. It didn’t say why it didn’t do so earlier, before the agency made its original decision in January.
Public health experts warned that countries that decline to recognize vaccines backed by WHO are complicating global efforts to safely restart travel.
“You can’t just cut off countries from the rest of the world indefinitely,” said Dr. Raghib Ali of the University of Cambridge. “To exclude some people from certain countries because of the vaccine they’ve received is wholly inconsistent because we know that these approved vaccines are extremely protective.”