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At least now the vaccine that the EU is fighting for is finally approved.
The European Commission issued a conditional marketing authorization Friday for the Oxford/AstraZeneca viral vector vaccine, capping a week-long standoff between the EU and AstraZeneca over drastically reduced shipments that will leave the bloc with at least 75 million fewer doses than expected by the end of March.
Hours before European regulators’ recommendation, the Commission and AstraZeneca published a redacted version of the contract to try and clarify the issue. Hours later, Brussels introduced new export restrictions on coronavirus vaccines to try and rectify the issue.
These political moves will not instantly deliver more of the 300 million doses of vaccines secured for the EU. But the approval provides at least another tool for Europeans in the race to vaccinate as many people while new variants sweep across the bloc.
As has become typical for the British vaccine, however, the EMA recommendation is bound to cause more issues. Its announcement approves the Oxford/AstraZeneca jab for adults over 65, but the recommendation wasn’t universally shared.
On Friday, a final assessment from German scientists who advise the government on vaccines said otherwise, repeating their draft position issued Thursday that there wasn’t enough data to recommend use of the vaccine in that age group.
The EMA’s assessment addressed that concern, noting that while only 13 percent of trial participants the agency reviewed were over the age of 55, “there is no reason to expect that this would not have some level of efficacy in that in that age group,” said Bruno Sepodes, vice chair of EMA’s human medicines committee.
“The exact level of protection [in this group] cannot be estimated for the time being,” Sepodes explained. “This is to say that it can be used; if there are other options, those could be preferred in specific situations.”
Andrew Pollard, director of the Oxford Vaccine Group, which developed the jab, said Friday that countries can make their own decisions on who should receive the vaccine, “based on their populations and supply of vaccine.”
While data in the elderly was “limited,” this “doesn’t mean it translates into a lack of protection,” he added. “It’s a perhaps a misunderstanding of evidence.”
The agency will get more data by the end of March from a U.S. trial of approximately 30,000 people with a “substantial” number of elderly people.
Still, Germany — or any other EU country — could choose not to use the vaccine for certain populations.
EMA executive director Emer Cooke defended the agency’s decision while leaving the door open for national scientists to choose otherwise: “It was about having options available.”
“We are saying that according to the information we have and the scientific evaluation, it can be used in patients over 18, and we’re not restricting it to under 55,” Cooke said. “And this is based on the evidence and the trials, the safety profile, and the immunogenicity [of] that chosen expectation of effect in older populations.”
European regulators also looked at efficacy data from only two of the four large scale human trials. Those reported a 59.5 percent percent efficacy rate — lower than the 70 percent efficacy rate declared by Oxford and AstraZeneca in November.
Regulators explained that they looked at one trial in the U.K. and another in Brazil, but the other other trials were not considered in this calculation as there were not enough COVID-19 cases to estimate efficacy.
Another smaller group — 1,367 people who initially received a half-dose that resulted in a 90 percent efficacy rate — was also not evaluated by European regulators. The EMA’s Sepodes said they “extensively discussed” this question, but because there too many confounding variables, it was hard to accurately calculate efficacy in this group.
AstraZeneca confirmed Friday that it will not study the half dose further.
“We’re very confident with the data we have,” said Mene Pangalos, head of BioPharmaceuticals R&D, at AstraZeneca.
As Sepodes saw it, the 59.5 percent efficacy rate is a positive step in fighting the pandemic.
“As a public health tool, 59.5 percent efficacy is relevant, especially when you have to deal with … the lack of other options in this case,” Sepodes said. “There is clearly a population in the EU and the world that will benefit from this tool.”
The EMA also recommended that the second dose be given between four and 12 weeks apart. Beyond this, the data became “thinner and thinner,” Sepodes said.
Regulators did look at all four trials to determine the “reassuring” safety profile, however. They found that while allergic reactions may occur, this was a “very, very rare” event. To err on the side of caution, they called for administering the vaccine under close medical observation, with those vaccinated monitored for at least 15 minutes after receiving the jab.
The most common side effects were pain and redness at the injection site, headache, tiredness, pain in the muscles and the joints, headache, nausea, vomiting, and diarrhea. However, these side effects were mostly mild and didn’t last very long.
Regulators said that more data are needed on the vaccine’s efficacy in people who are pregnant, breastfeeding or are immuno-compromised.
Meanwhile, the EU’s standoff with AstraZeneca over supplies of the vaccine got only some clarity with the release of the contract. With many of the central provisions redacted, it’s still not clear how many doses the company committed to sending to the EU.
Speaking after the EMA’s decision, AstraZeneca CEO Pascal Soriot said the company will deliver three million doses to the EU in its first shipment, with three shipments in total in February. He would not commit to the numbers.
Asked if the company would hit 31 million doses by March, he said the company is aiming for that arrangement and “possibly above — we’re working on improving this number.”
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