Limited approval for conceivable AstraZeneca vaccine – Coronavirus –

“I will not anticipate the decision,” EMA chief Emer Cooke told a hearing in the European Parliament on Tuesday. Basically limited entry is possible. This will be carefully checked. Criticism of AstraZeneca continued from the EU on Tuesday.

Cooke confirmed that there was little trial data for the AstraZeneca vaccine in the elderly. In the approval process, the EMA is now checking all available data to see what it says for the population groups assessed and what can be conclusively concluded from this for other groups. The authority is still receiving new data from the manufacturer for the ongoing approval process. These will help better evaluate the performance of the vaccine, Cooke said.

Cooke also reported at a health committee hearing that a fourth vaccine, the Johnson & Johnson product, was already being examined by the EMA in a so-called ongoing review. But there is still no timetable for an approval decision. The EMA has not yet received an application for approval of the Russian Sputnik V vaccine. But you already have contacts with the manufacturer.

The EU fell out on Tuesday with AstraZeneca and the group’s announcement that it would deliver significantly less than the amount of vaccine doses originally agreed upon by contract. The approval of the vaccine by the European Medicines Agency (EMA) is scheduled for Friday. On Tuesday, EU budget commissioner Johannes Hahn and his boss, commission chair Ursula von der Leyen, sent criticism and calls to keep the treaties, among others.

Hahn reiterated the “annoyance” from the EU Commission about the pharmaceutical company AstraZeneca and its announcement that it could not deliver the contractually agreed amount of corona vaccine for the time being. At the moment, “there are no satisfactory answers,” Hahn told reporters on Tuesday. They wait for a solution by the end of the week, then they will assess the situation again.

When asked if the EU Commission would take legal action against AstraZeneca, the Austrian EU Commissioner replied: “The focus must now be on complying.” Every effort is being made to improve the situation, possibly increasing delivery of the corona vaccine from other providers. However, if AstraZeneca does not provide a satisfactory answer, Hahn said, then of course legal action, as EU Council President Charles Michel pointed out, is a possible consequence.

Enough money has been made available to vaccine providers, Hahn said. The funds would also have to be used to develop production capacities in Europe, “not just anywhere, but in Europe,” the EU commissioner stressed. You will closely observe what is happening in the productions in terms of distribution.

Earlier, EU Commission President Ursula von der Leyen called on corona vaccine manufacturers to meet their delivery obligations. Europe has “invested billions to support the development of the world’s first Covid-19 vaccine,” von der Leyen said Tuesday in his video-broadcast speech to the World Economic Forum. “And now companies have to comply, they have to fulfill their commitments.” Von der Leyen reiterated that the Commission is planning a “transparency mechanism for the export of vaccines” to countries outside the EU.

AstraZeneca announced on Friday that following approval by the European Medicines Agency (EMA) scheduled for this week, it initially wanted to deliver less vaccine than planned to the EU. Instead of 80 million doses of vaccines, only 31 million should be planned by the end of March. Brussels has ordered a total of up to 400 million cans from the company. On Friday, the EU Medicines Agency EMA could recommend approval for the European market.

In Brussels it is suspected that the company is supplying non-reduced quantities to other countries such as Great Britain outside the EU. “We see the cans being delivered elsewhere,” the commission spokesman said. Since the EU made advance payments for production, “these cans should be available for delivery” as soon as the EMA gives the green light.

According to Brussels, in two meetings with the EU Commission and member states on Monday, AstraZeneca was unable to adequately explain how delivery bottlenecks occurred. According to the commission, another meeting with the company is now scheduled for Wednesday. The Commission does not consider AstraZeneca’s reference to production problems at a supplier in Belgium valid.

The EU authority is now planning a “transparency mechanism for the export of vaccines” to countries outside the EU. Furthermore, however, the Commission confirmed that this is not a ban on the export of corona vaccines manufactured in the European Union to third countries.

“It is not about blocking, but about knowing which companies are exporting to markets outside the EU,” a commission spokesman said on Tuesday. Brussels had announced on Monday in the context of delays in deliveries at manufacturer AstraZeneca to introduce such a “transparency mechanism”.

A leading British health expert had previously warned about restrictions on exports of vaccines from the European Union. “If that happened, of course it would be worrying,” the head of the National Health Service (NHS), Simon Stevens, told MPs on Tuesday. The goal of vaccinating the most vulnerable people by mid-February would be compromised. However, he doesn’t think there are likely to be problems.

Doctors, hospitals and all partners would do well to “get the vaccines going now,” Stevens said. “So we don’t want this progress to stop.”

>> Register here for vaccination in Vorarlberg