The Limited Times

Now you can see non-English news...

EU agency recommends approval of Omikron BA.5 vaccine

2022-09-12T16:09:21.733Z


At the beginning of September, the EU approved two vaccines adapted to the omicron variant BA.1. The EU drug agency Ema is now recommending that a Biontech vaccine against the variants BA.4 and 5 be brought onto the market.


Enlarge image

Vaccination patch (icon image)

Photo: AITOR DIAGO / Getty Images

The US already granted an emergency authorization on August 31 - now the EU medicines agency Ema recommends authorizing the corona vaccine from Biontech and Pfizer in the European Union, which is directed against the Omicron sublines BA.4 and BA.5.

BA.5 currently causes by far the most coronavirus infections in Germany and worldwide.

The EU Commission must agree to the decision of the Ema Committee for Medicinal Products for Human Use (CHMP) before an authorization is granted.

But this is considered a formality.

The vaccine should be used in people who already have basic immunization against Sars-CoV-2 and are at least twelve years old, according to Ema.

Previously, the EU had already approved two bivalent vaccines from Biontech/Pfizer and Moderna, which are adapted to the omicron subline BA.1 in addition to the original virus type.

However, this variant no longer plays a role in this country.

The new vaccine is a modified form of the Comirnaty product, according to Ema.

The agent therefore still contains so-called mRNA, which conveys the blueprint for the spike protein of the coronavirus.

The vaccine causes body cells to produce this virus protein for a short time so that the immune system can train its defense against it.

However, the spike protein is not identical in every virus variant.

Especially in the case of the omicron sublines, it differs significantly from the original form.

Vaccines adapted to omicron variants should help to improve the defense against them.

In addition, the blueprint of the original spike protein is also included in the remedies.

Because nobody knows whether future Sars-CoV-2 variants might again have a spike protein that resembles the original version more than that of BA.1 or BA.

In the SPIEGEL interview, Biontech founder Uğur Şahin said that there was “no huge difference” between the two vaccines – i.e. the one against BA.1 and the one against BA.4/5.

"Both have shown in investigations that they produce a clearly superior antibody response to omicron compared to the original vaccine." Paul Burton, Chief Medical Officer at Moderna, also said in the SPIEGEL interview , which of the two vaccines this fall and winter at the end of will be better, one cannot really foresee yet.

"The bivalent BA.1 booster also increases the antibody level against the currently dominant BA.5 variant." In the USA, a bivalent vaccination directed against BA.5 received emergency approval at the same time as Biontech's agent.

The Standing Vaccination Commission (Stiko) in Germany is currently recommending a second booster vaccination against Covid-19 for everyone over the age of 60.

This advice also applies to anyone over the age of five who has a higher risk of severe disease due to a medical condition.

The panel recommends administering this booster no earlier than six months after the fourth vaccination or a corona infection.

Stiko has not yet issued a statement on the bivalent vaccines.

After the emergency approval of the BA.4/BA.5 vaccines from Biontech and Moderna in the USA, there was criticism because these funds had not been tested in studies on humans, but only on a small number of mice - eight each in several vaccine groups .

For the approval, the manufacturers presented the study data for their respective products, which are directed against BA.1.

These were tested in studies with several hundred participants.

The US Food and Drug Administration said it considered these data "relevant and supportive of the BA.4 and 5 vaccines."

The safety and effectiveness data of the previous corona RNA vaccines, which had been administered millions of times, also contributed to the authority's decision.

Ema also reports that its decision is based on the clinical data on the BA.1 vaccine, corresponding studies with the agent against the variants BA.4 and 5 are still ongoing.

"Apart from containing mRNA based on different but closely related omicron sublineages, Comirnaty Original/BA.1 and Comirnaty Original/BA.4-5 have the same composition," says Ema.

wbr

Source: spiegel

All tech articles on 2022-09-12

You may like

Trends 24h

Latest

© Communities 2019 - Privacy

The information on this site is from external sources that are not under our control.
The inclusion of any links does not necessarily imply a recommendation or endorse the views expressed within them.