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The U.S. health regulator, the NIAID (National Institute of Allergy and Infectious Diseases), has expressed concerns about the validity of data from the new study by the pharmaceutical company AstraZeneca on its vaccine.
The study is based on the results of a Phase III trial involving around 32,500 subjects, which, according to the manufacturer, show that the vaccine is highly effective. In its statement, the NIAID commented that “it was concerned by information released by AstraZeneca on initial data from its Covid-19 vaccine clinical trial”.
“The DSMB has expressed concern that AstraZeneca may have included outdated information from this study that may have provided an incomplete view of the efficacy data,” NIAID announced on Monday, citing the Data and Safety Monitoring Board (DSMB). It said the company must review the data and ensure that the most accurate and up-to-date information is published as soon as possible.
On Monday, March 22, AstraZeneca announced that a Phase III study involving about 32,500 subjects in the U.S., Chile, and Peru confirmed that its vaccine is 79% effective against COVID-19. For subjects over 65 years old, the vaccine has over 80% efficiency. This means that among older subjects in a vaccinated group, 80% less disease occurred than among those in a control group. The efficacy across all age groups in terms of severe disease progression is 100%, meaning none of the volunteers developed severe symptoms, were hospitalized, or died. Previous studies had also independently confirmed the vaccine’s high effectiveness.
The British-Swedish company developed the vaccine, called AZD1222, in collaboration with Oxford University. It has been used widely in the UK since January.
In response, AstraZeneca commented, “We have reviewed the preliminary assessment of the primary analysis, and the results were consistent with the interim analysis. We will immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up-to-date efficacy data. We intend to issue results of the primary analysis within 48 hours.”
The EU Commission has announced its decisive action against the vaccine maker’s supply shortfalls. At the same time, the EU Commission announced it would revise on Wednesday the export control for vaccines that were introduced in February. EU Commission chief Ursula von der Leyen had recently threatened AstraZeneca with banning further exports to countries outside the EU. General director of the European Commission, Sandra Gallina, now made it clear that other companies that fulfilled their contracts would probably not have to deal with export stops. The heads of state also expected to discuss this at the EU summit on Thursday. Chancellor Merkel has also recently spoken out against general export bans on COVID-19 vaccines.
AstraZeneca is significantly behind with its deliveries to the EU. Instead of the 120 million vaccine doses originally targeted, only 30 million are due in the first quarter, and 70 million doses instead of 180 million in the second quarter.
Gallina now said that, according to the contract, the company was supposed to supply the European market from five production sites. Instead, she said, it is producing at only one plant. Another plant under the contract has yet to be approved by the European Medicines Agency. That process has just been started by the company, she said. “We definitely would not have obtained more doses with more money,” Gallina told the Parliament budget committee. “I think the prices we have paid are fully justified. The problem … is manufacturing.” Gallina commented.
She added that delivery failures and the bumpy start to the vaccination process had done significant damage to the reputation of the EU institutions. Many people were dying because the vaccine was not being delivered, but the EU itself is not to blame; according to Gallina, “I’ve no envy for Israel. I’m not jealous of what [US President Joe] Biden is doing – we’re better than the US [on COVID],”
Referring to Johnson & Johnson’s vaccine, which has already been approved in the EU but not yet been delivered, Gallina said the first deliveries were expected in mid-April. In London, AstraZeneca shares temporarily lost 1.01% to 72.42 GBP.
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