Johnson & Johnson applies for EU approval

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U.S. pharmaceutical company Johnson & Johnson has applied for approval of its coronavirus vaccine in the European Union (EU). The Amsterdam-based European Medicines Agency (EMA) said Tuesday it has received an application for “conditional marketing authorization” from Johnson & Johnson’s European subsidiary.

So far, vaccines from Biontech/Pfizer, Moderna and AstraZeneca have been approved in the EU. Johnson & Johnson had already filed for emergency approval of its vaccine in the U.S. nearly two weeks ago.

If the company manages to secure approval, experts say it will significantly simplify the vaccination campaign: Unlike the other vaccines, Johnson & Johnson requires only one injection. EU Commission President Ursula von der Leyen welcomed the manufacturer’s move. The EU Commission will grant approval as soon as the EMA has issued a positive scientific assessment, von der Leyen said.

Evaluation targeted by mid-March
The EMA said it would review the approval in an accelerated procedure. The committee responsible could deliver its assessment in mid-March.

A prerequisite is that the company’s data on the vaccine’s efficacy, safety and quality are comprehensive and robust, he said. Such a short review is only possible, he said, because the EMA has already pre-assessed some data in the rolling review process.

The European Commission has ordered 200 million doses of Johnson & Johnson’s active ingredient, with an option for 200 million more. If approved, 100 million doses could be delivered by June.

Austria has ordered 2.5 million doses from Johnson & Johnson as part of the EU procurement. In total, the order amounts to a total of 30.5 million doses of vaccine. Specifically, in addition to those from Johnson & Johnson, these include 5.9 million from AstraZeneca, 11.1 million from Biontech/Pfizer, three million from CureVac, 4.7 million from Moderna, 1.9 million from Novavax and 1.2 million from Valneva, and 200,000 from Sanofi. The cost of these is 388.3 million euros.

Over 100,000 vaccinations last week
Last week, for the first time, more than 100,000 coronavirus vaccinations were given in Austria and entered into the electronic vaccination record. This means that 245,209 people (2.8 percent of the population) have now received at least a first dose and 145,161 have received the second (1.6 percent). The vaccination coverage rate is highest among the 226,000 people over 85 years of age: Here, nearly 18 percent have received at least a first dose and 11 percent have received the second dose.

According to the vaccination schedule, most of the people currently being vaccinated are nursing home residents, medical personnel, and people over 80 years of age. In total, the number of vaccinations increased significantly last week. With 104,077, a quarter more vaccinations were registered in the vaccination register than in the previous week (81,804).

Anschober plans increased pace in second quarter
However, more than 380,000 vaccinations (first and second doses) are still needed to vaccinate all Austrians over the age of 85. At the current pace, this would take several more months, as only 16,282 vaccinations were added in this age group last week. However, Health Minister Rudolf Anschober (Greens) recently announced a much faster pace in the second quarter. He wants to reach two million vaccinations by the beginning of April.

  • source: orf.at/picture: pixabay.com
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