AstraZeneca Covid-19 Vaccine Gets EU Regulator Approval

The European Medicines Agency approved AstraZeneca’s Covid-19 vaccine for use in everyone over 18 years of age on Friday.

It means that doses can now be rolled out in Ireland as soon as deliveries are available from the British-Swedish pharmaceutical company.

The decision is a boost for vaccine programs, after Germany’s public health agency recommended the vaccine for use only in people 18 to 64 years old, citing a lack of data from AstraZeneca trials among 65 people. years or more.

“With this third positive opinion, we have further expanded the arsenal of vaccines available to EU and EEA member states to combat the pandemic and protect their citizens,” said EMA chief Emer Cooke.

“As in previous cases, the CHMP [the committe on human medicines] has rigorously evaluated this vaccine, and the scientific basis of our work supports our strong commitment to safeguarding the health of EU citizens. “

In a statement, the EMA acknowledges that a small number of older people participated in the AstraZeneca trials. However, the rest of the evidence supported approval of the vaccine for all age groups over 18, the regulator said.

“Protection is expected, given that an immune response is observed in this age group and based on experience with other vaccines,” the EMA said in a statement.

“As there is reliable information on safety in this population, the EMA scientific experts considered that the vaccine can be used in older adults. More information is expected from ongoing studies, which include a higher proportion of older participants. “

The recommendation will now go to the European Commission for final approval.

The recommendation comes amid a simmering discussion over AstraZeneca’s announcement that EU states will only get a fraction of expected supplies in the first quarter.

Ursula von der Leyen has said that it is “very clear” that AstraZeneca is bound by its contract to deliver UK-produced coronavirus vaccine doses to the EU to make up for the production shortfall in Belgium.

When a redacted version of the disputed contract was released on Friday, the commission chairman dismissed AstraZeneca chief executive Pascal Soriot’s arguments that the British government had an early claim on the doses produced in Oxford and Staffordshire.

Dr. von der Leyen said that the Anglo-Swedish pharmaceutical company was legally obliged to use the four plants mentioned in its contract, two in the UK, one in Belgium and a fourth in the Netherlands, to fulfill the promised order. .

The European Commission has paid 336 million euros for 400 million doses, of which the first 100 million were to be delivered in the first quarter of this year.

Dr von der Leyen continues to demand that the British pharmaceutical group provide a “plausible explanation” for its looming shortfall in vaccine deliveries to the EU.

His comments on German public radio came hours before the EU medical agency is expected to recommend approving the vaccine for use in member states, which is then passed to the commission for formal approval.

The published contract confirms the EU’s position that the supply of its 300 million contracted doses of the vaccine would be delivered from plants, including those located in the UK.

There is no provision in the contract stating that supplies destined for the EU from any of the plants were subordinate to supplies from those plants to other customers, including the UK.

“We want to know what is going on,” said Dr. von der Leyen on Deutschlandfunk. “What I am demanding is transparency and reliable planning.”

A week after the company announced that it was reducing its deliveries to the EU from 80 million to 31 million doses, the European Commission will publish its contract with AstraZeneca on Friday, with sensitive passages crossed out.

While the firm claims its contract with the EU contains a “best effort” clause, Dr. von der Leyen said this applied only to the period before a vaccine was developed.

“This period is behind us, the vaccine is here and it only has to go through the final tests,” he said. “Now there are very clear delivery quantities for December of the last years and also for the first, second and third quarters (of 2021).

The contract with the EU was “very clear,” he added, with “binding” delivery capabilities on the list.

“AstraZeneca explicitly promised us that no other obligation will stand in the way of fulfilling this contract, and that is all that counts here,” he said.

It was understandable, given the speed of development and production of the Covid-19 vaccine, that problems could arise, he said.

But production problems with BioNTech, another vaccine company, had been resolved and things “were going well,” he said, after open discussions with officials on his commission.

She said there was no reason why, given the reported problems at AstraZeneca’s Belgian production facility, two UK companies couldn’t step in to fill the gap.

“The contract has production facilities that can produce the delivery quantities,” he said.

The firm has said that its contract with the United Kingdom forces it to prioritize vaccines manufactured there for the British health service.

The European Medicines Agency (EMA) will decide on Friday whether to approve AstraZeneca’s Covid-19 vaccine amid a fierce dispute over a drastic cut in expected deliveries by the British-Swedish pharmaceutical company.

The measure has spurred the EU to take measures to control exports of vaccines from the bloc.

German health authorities recommended on Thursday that AstraZeneca’s Covid-19 vaccine not be given to people over the age of 65 due to a lack of data, in a possible further blow to vaccination efforts in Ireland and across the European Union.

Currently, there is “insufficient data available to determine how effective vaccination is above age 65,” the vaccines committee of Germany’s main public health agency, the Robert Koch Institute, said in a statement. “The AstraZeneca vaccine, unlike mRNA vaccines, should only be offered to people ages 18 to 64 at each stage.”

Only 341 people over the age of 65 in the AstraZeneca trial received the vaccine and 319 received a placebo, meaning there is very little data available to show with certainty the effectiveness of the vaccine in that age group, the committee said.

The UK has already launched the vaccine and thousands of people have received it in Northern Ireland. Public Health England has said that while there were too few cases in older people in the AstraZeneca trials to measure protection with certainty, the data on immune responses were “very reassuring.”

Data from the AstraZeneca trial is also being challenged in the United States, where a pension fund has filed a lawsuit on behalf of investors who blame the company for including too few seniors and for trial confusion in which some participants were only accidentally given half a dose as one of their injections.

The EMA is expected to make a decision on licensing the vaccine on Friday and has not so far indicated whether the doses could be approved only for younger age groups.

AstraZeneca would be the third Covid-19 vaccine available in the EU if approved, following BioNTech-Pfizer and Moderna, and is key to national vaccination strategies because it is easier to implement as it does not need to be deep frozen.

In Dublin, the government is developing contingency plans if it cannot manage AstraZeneca to those over 65. However, government sources said there is confidence that there will be enough supplies from Pfizer from mid-February onwards to allow for vaccination of the elderly, but admitted that logistical problems would be more challenging if necessary.

Sources said the third cohort on the vaccine list, those over 70, could still be ready by late spring, rather than March, if AstraZeneca were not available.

Novavax vaccine

Novavax Inc said Thursday that its coronavirus vaccine was 89.3% effective in preventing Covid-19 in a trial conducted in the UK, and was almost as effective in protecting against the most contagious variant of Covid. -19 first discovered in the UK, according to preliminary analysis.

A mid-stage trial of the vaccine in South Africa, where a potent variant of the virus is common, showed 60% effectiveness among people who did not have HIV.

Novavax said the UK trial, involving 15,000 people aged 18 to 84, is expected to be used to request a regulatory review in the UK, the EU and other countries. About 27 percent of the people in the trial are over 65. Additional report from Reuters