This post was originally published on this site
AstraZeneca’s COVID-19 vaccine should only be given to people under the age of 65, Germany’s vaccine committee recommended on Thursday, citing insufficient data on its efficacy among older people.
The news comes as Europe’s vaccine supply problems threaten to develop into a full-blown crisis, with German health minister Jens Spahn warning the country faces a “tough 10 weeks” of shortages.
The European Medicines Agency is expected to grant emergency authorization for use of the AstraZeneca vaccine, which the drug company developed with the University of Oxford, in the EU on Friday. But the independent commission advising the German government said the shot should only be given to people aged between 18 and 64.
“There are currently insufficient data available to assess the vaccine efficacy from 65 years of age,” the committee said in a statement released by the German health ministry. “The AstraZeneca vaccine, unlike the mRNA vaccines, should only be offered to people aged 18-64 years at each stage,” it added, according to Reuters.
Read: AstraZeneca–Oxford COVID shot is ‘safe and effective,’ full trial data show
A spokesperson for AstraZeneca said: “The latest analyses of clinical trial data for the AstraZeneca/Oxford COVID-19 vaccine support efficacy in the over 65 years age group. We await a regulatory decision on the vaccine by the EMA in the coming days.”
Shares in AstraZeneca, which fell as much as 2.4% after the news, recovered to trade 0.89% lower in midafternoon in London on Thursday.
As Europe battles with vaccine shortages, the U.K. has started manufacturing up to 60 million doses of a new COVID vaccine — on its home turf.
French biotech Valneva will start producing its experimental COVID shot at a plant in Livingston, Scotland, ahead of trials and regulatory approval, the government announced on Thursday.
“By starting manufacturing, we will have a running start at rolling these out as quickly as possible to protect the British public if it receives regulatory approval,” said business secretary Kwasi Kwarteng.
Health secretary Matt Hancock said on Twitter TWTR, +6.02% that the Valneva vaccine “will be another vital tool in our fight against the virus if approved.”
His comments came as the European Union faces increasing pressure about the speed of its inoculation program, which has been worsened by drug companies AstraZeneca AZN, -1.35% and Pfizer PFE, +0.70% both announcing delays in delivery of their vaccines because of production issues at European plants.
German health minister Jens Spahn said the country is likely to face a shortage of vaccine until April, as he called for a vaccination summit to look for ways of accelerating the rollout in the bloc.
“We will still have at least 10 tough weeks with a shortage,” he said in a tweet on Thursday.
Meanwhile, Madrid’s health authorities said on Wednesday that they have suspended COVID vaccinations this week and next as they are running out of shots.
“Unfortunately, as we suspected the pace of deliveries was interrupted,” Madrid’s deputy regional president Ignacio Aguado told reporters, adding that the region has vaccinated 180,000 people since the campaign started.
By contrast, more than 7.1 million people across the U.K. have now had a least one dose of either the AstraZeneca–Oxford vaccine, or the shot made by German biotech BioNTech 22UA, +0.99% and its U.S. partner Pfizer 0Q1N, -2.14%.
The government, which has set a target to have 15 million of the most vulnerable citizens inoculated by mid February, has secured early access to 367 million doses of seven vaccines, including the one made by U.S. biotech Moderna MRNA, +7.45%.
The EU, which signed a deal with AstraZeneca AZN, +0.89% in August for 300 million doses, with an option for 100 million more, is now demanding that the U.K.-Swedish drug company diverts supplies of its COVID-19 vaccine from U.K. plants to address the shortage.
Read: EU demands access to U.K.-made AstraZeneca vaccine shots as row over shortages intensifies
The two sides met late on Wednesday, during which AstraZeneca Chief Executive Pascal Soriot pledged to work with the EU, to resolve the issue.
“ “We have committed to even closer coordination to jointly chart a path for the delivery of our vaccine over the coming months as we continue our efforts to bring this vaccine to millions of Europeans at no profit during the pandemic.” ”
“We had a constructive and open conversation about the complexities of scaling up production of our vaccine, and the challenges we have encountered,” an AstraZeneca spokesperson said. “We have committed to even closer coordination to jointly chart a path for the delivery of our vaccine over the coming months as we continue our efforts to bring this vaccine to millions of Europeans at no profit during the pandemic.”
EU health commissioner Stella Kyriakides said in a tweet late on Wednesday that the 27-member bloc regretted the “continued lack of clarity” on the delivery schedule.
The meeting between the EU and AstraZeneca took place just hours after French pharmaceutical company Sanofi SAN, -0.23% said that it will team up with BioNTech 0A3M, +1.00% and Pfizer to manufacture up to 125 million doses of their COVID shot.
Valneva is developing an inactivated, whole-virus vaccine, a more traditional approach than the one from BioNTech BNTX, +3.24% and Pfizer, which uses the so-called messenger RNA, or mRNA, approach, which sends a message to cells telling them to create proteins that can generate an immune response.
Read: New COVID-19 vaccine candidate Valneva starts clinical trials
The French company’s vaccine candidate is currently in Phase 1 and Phase 2 clinical trials, involving 150 volunteers in sites across Bristol, Birmingham, Southampton and Newcastle, to evaluate the safety of the experimental shot, and whether it produced an immune response is healthy adults.
If successful, Valneva will carry out a larger study in April 2021, with more than 4,000 volunteers testing two doses of the vaccine in two groups: those aged between 18-65 years and the over 65s. The vaccine candidate could then become available by the fourth quarter of 2021.
“We believe that our vaccine, assuming successful development, can make a major contribution in the U.K. and beyond,” said Valneva Chief Executive Thomas Lingelbach in a statement on Thursday.
