Just hours after AstraZeneca said the late-stage trials of its COVID-19 vaccine proves its “100% efficacy against severe or critical disease and hospitalization,” a key U.S. government oversight agency expressed concern about the information released by the drug maker.
The Data and Safety Monitoring Board (DSMB) issued a statement early Tuesday that the British-Swedish pharmaceutical giant “may have included outdated information” from the late-stage clinical trial, “which may have provided an incomplete view of the efficacy data.”
AstraZeneca said Monday that its analysis of the safety and efficacy of its vaccine, developed jointly with Britain’s University of Oxford, was based on more than 30,000 participants in U.S. trials. Researchers at Oxford also said the vaccine is 79% effective against preventing symptomatic coronavirus.
The DSMB urged AstraZeneca to work with it to review the data and “ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.”
The statement from the independent board of experts is just the latest setback for the Oxford-AstraZeneca vaccine, which has had a troubled rollout across the world. Several European countries had recently stopped use of the AstraZeneca vaccine because of reports that it was associated with blood clots in recipients. And South Africa stopped using the shot due to concerns about its efficacy against a local variant of the virus. The country sold at least a million of its AstraZeneca COVID vaccines to the African Union.
But the European Medicines Agency, the drug approval body for the European Union, said the vaccine is safe and does not raise the overall risk of blood clots. The World Health Organization has subsequently recommended the use of the Oxford-AstraZeneca vaccine against variants of the coronavirus, and that it considers its benefits outweighs its risks.
The Oxford-AstraZeneca vaccine has been the leading choice among the developing world because of its low-cost and simple storage requirements. South Korean President Moon Jae-in was inoculated with the vaccine on Tuesday.
Germany extend lockdown
Meanwhile, German Chancellor Angela Merkel said Tuesday the government is extending the country’s lockdown until April 18, citing the steady rise of new infections. The extended restrictions include a total lockdown between April 1-5 during the upcoming Easter holiday, with a request for all Germans to stay home during the period.
Merkel and all of the country’s 16 state governors had recently crafted a plan to gradually lift the coronavirus restrictions by March 28. But Germany has been plagued by a spike in new infections due to the more infectious B.1.1.7 variant, along with the slow pace of vaccinations, with only 9% of the population having received at least one shot of the vaccine.
“We basically have a new pandemic,” Merkel told reporters in Berlin Tuesday.
The B.1.1.7 variant was first detected in the United Kingdom and it is easily transmitted and more deadly, Dr. Anthony Fauci warned during a White House press conference on Friday.