• The Star Staff

European medicines agency will deliver assessment of AstraZeneca vaccine

By Marc Santora and Monika Pronczuk


After more than a dozen nations, mostly in Europe, suspended use of AstraZeneca’s coronavirus vaccine over safety concerns, the European Union’s lead medical regulator will announce the findings of a safety review Thursday.


In recent days, officials have signaled that they are likely to restate their previous findings that the vaccine is safe and effective. They have framed the pause as a way to reassure the public that all concerns are treated seriously and to limit any wider damage to the public’s trust about vaccines.


The nations that halted use of AstraZeneca’s vaccine — a move that roiled an already troubled vaccination campaign across the continent — said they were waiting for updated guidance from the regulator, the European Medicines Agency, and were likely to restart using the vaccine.


The pause threatens to have lingering consequences both in Europe, which is struggling to contain a new wave of infections, and around the world. The AstraZeneca vaccine is a keystone of the World Health Organization’s effort to inoculate poor and middle-income countries.


“In extensive vaccination campaigns, it is routine for countries to signal potential adverse events following immunization,” the WHO said Wednesday. “This does not necessarily mean that the events are linked to vaccination itself, but it is good practice to investigate them.”


The statement was one of many aimed at calming anxious governments and their populations at a particularly precarious moment in the pandemic.


All of the coronavirus vaccines approved by Western regulators have shown themselves to be effective at reducing severe illness and death. And although AstraZeneca’s vaccine accounts for less than 20% of the hundreds of millions of doses ordered by the European Union, it is a critical part of early rollout plans.


With infections again on the rise in many countries in Europe, the cost of delay may be measured in lives. In just one week in January, at the height of the last wave, Europe recorded nearly 40,000 deaths.


This week, more people are on ventilators in hospitals in Poland than at any other time in the pandemic, leading officials to reimpose national restrictions starting Saturday. Italy has reimposed lockdowns in the hopes of limiting outbreaks. From Prague to Madrid, there is rising concern over the spread of more contagious variants.


In Paris, the head of the public hospitals said that the situation was increasingly dire and that they were struggling to find enough beds in intensive care units.


“We are living through the hardest weeks now — we know it,” President Emmanuel Macron of France said Wednesday.


The hope was that by this time vaccinations would allow governments to avoid reimposing the often draconian restrictions that have been a part of life across Europe for the past year.

The suspensions of AstraZeneca’s vaccine underscored how even relatively minor disruptions can have an outsized impact as the global coronavirus vaccine supply remains exceedingly tight.


Few nations find themselves in the enviable position of the United States, which has secured more than enough doses for every adult in the country. It is also sitting on about 30 million doses of the AstraZeneca vaccine, which the Food and Drug Administration has yet to approve for emergency use.


Even Britain, which moved quickly to procure vaccines and has been rapidly rolling out doses to most people older than 50, has had to shift its strategy in part to deal with dips in supply.


British regulators chose starting late last year to allow an increased gap between the two doses of many of the vaccines required for maximum protection: up to 12 weeks rather than the three weeks used in clinical trials.


That has allowed Britain to give initial protection to about 25 million people. But many of those will soon need a second dose, putting pressure on the system and leading officials to warn that distribution in April will move more slowly.