Vials of AstraZeneca Plc and Oxford Covid-19 University vaccines.
Photographer: Anthony Devlin / Bloomberg
Photographer: Anthony Devlin / Bloomberg
The European Union drug regulator has released a Covid-19 vaccine from AstraZeneca Plc and the University of Oxford for all adults, as the deficit in expected deliveries increases tensions between the company and the bloc.
Green Friday opens the way for the European Commission to issue a conditional marketing authorization. The Astra-Oxford vaccine will be the third available in the EU after injections of Pfizer Inc. and Moderna Inc., and could help alleviate vaccine shortages, as the EU lags behind the UK and the US in vaccinations.
The decision will not immediately mean more injections for the elderly in Europe’s largest country. The German immunization authority said that inoculation should be allowed only for people aged between 18 and 64, fulfilling a preliminary recommendation. He cited the lack of trial data in older groups.
The European Medicines Agency said that although the majority of trial participants were between 18 and 55 years old and there was insufficient data to determine the vaccine’s effectiveness in older adults, the injection showed an immune response in the older age group and is safe.
The agency said the two-dose vaccine would be administered in vaccines every four to 12 weeks, according to the recommended gap in the UK. Despite varying testing intervals, 86% of volunteers received an injection within that period, Bruno Sepodes, vice chairman of the EMA committee, said at a news conference.
EU Standoff
The release follows a tense week between the bloc and vaccine makers after Astra said it could not deliver the expected number of injections in the coming months due to production problems. This led the EU to impose regulations on vaccine exports. The region, along with the United Kingdom, also faces delays for the Pfizer photo, developed with the German partner BioNTech SE, while the companies renovate a factory in Belgium.
The agency focused on test results showing that the AstraZeneca vaccine has an efficacy rate of about 60%, according to a statement. Although the safety of the vaccine has been demonstrated in four studies, the authorities based their calculations on how well it worked on tests in the UK and Brazil just because of the infection rates in those studies.
AstraZeneca’s shares closed 2% down in London.
The EMA committee excluded data in its assessment of an arm of the trial that received a lower first dose and produced a higher effectiveness reading of around 90%, because there were “several speakers” who made it difficult to know how accurate that number of participants was. effectiveness really was, said Sepodes. The half dose was administered only to young adults in the trials.
At this point, there is no data to show whether the vaccine is effective against new variants of the virus that have caused alarm, EMA Executive Director Emer Cooke said at the briefing.
US test data
US approval for the AstraZeneca shot is still a long way off. The EMA said it expects data from a trial in the United States that may shed more light on the vaccine’s effectiveness in the elderly at the end of the first quarter.
While European approval of another vaccine is a step forward in the fight against the pandemic, immunization alone will not stop the virus, she said, and each injection has some drawbacks. Although the AstraZeneca injection has shown less effectiveness than those of Pfizer and Moderna, it is easier to transport and store.
“None of them are perfect, none of them have all the characteristics that we would like to allow us to move forward completely, none of them is a magic wand in itself,” said Cooke.