EMA decides today on omicron boosters from Biontech/Pfizer and Moderna

Created: 09/01/2022 11:54 am

By: Martina Lippl

Corona in Germany: Omicron boosters from Biontech/Pfizer and Moderna are waiting for approval from the European Medicines Agency EMA.

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The European Medicines Agency EMA has two applications for approval of an omicron vaccine against the coronavirus on the table.

The Covid vaccines could be approved today.

Amsterdam – Experts have been talking about an adapted coronavirus vaccine against the omicron variant for months.

The European Medicines Agency (EMA) wants to decide on Thursday or Friday whether two Omikron vaccines from Biontech/Pfizer and Moderna will be approved.

The approval of the following

is considered a formality:

The two adapted omicron vaccines are about a

.

At the EMA, the Committee for Human Medicine is dealing with the evaluation of two so-called bivalent mRNA vaccines.

The vaccines are intended to offer protection against the original Sars-CoV-2 coronavirus as well as against the omicron subvariant BA.1.

Corona booster: is it worth waiting for the adapted omicron vaccine from Biontech/Pfizer and Moderna?

Federal Health Minister Karl Lauterbach (SPD) is already promoting the adapted BA.1-Omicron Booster from Biontech/Pfizer and Moderna.

"Now it really makes sense to wait a few days for the new vaccine to be available," said Lauterbach on Thursday in the ARD "Morgenmagazin".

Both new vaccines, adapted to the omicron variant, offer “very good protection” against old and new virus variants.

They contained parts of the old vaccine plus parts that protect against the omicron variants.

If the EMA approves on Thursday or Friday, the new vaccine could be delivered in the coming weeks.

A recommendation from the Standing Vaccination Commission (Stiko) is still pending.

This is causing criticism among general practitioners and specialists, who are now receiving many inquiries.

Also who needs a third booster, i.e. a fifth vaccination, when.

There are people who have not yet been infected with Corona.

Others are infected, vaccinated, boosted and reinfected.

Is it worth waiting for the vaccine adapted against omicron subtypes BA.4 and BA.5?

Adding to the confusion is that an even more advanced vaccine is on the horizon.

A corona vaccine adapted to the currently dominant

.

In the United States, on Wednesday (August 31, 2022), the Food and Drug Administration (FDA) granted REA clearance for two vaccines (bivalent vaccines) targeting these subtypes BA.4 and BA.5 from Moderna and Biontech/Pfizer.

In addition to the omicron subvariant, the so-called bivalent vaccines are also directed against the wild type of the coronavirus (2020).

Pfizer and Moderna had already submitted an application to the EMA.

It is checked in the so-called rolling review process - we are still waiting for further data.

This means that it is initially unclear when exactly the adapted vaccines from Biontech/Pfizer and Moderna can be vaccinated in Germany.

Waiting for boosters BA.4 and BA.5?

Immunologist Carsten Watzl makes a clear statement

Immunologist Carsten Watzl advises people who want to be vaccinated not to wait for the Omikron Booster BA.4 and BA.5.

"So far there is no clinical data on this vaccine candidate," said the Secretary General of the German Society for Immunology of the afp news agency.

One can only speculate about the benefits - also in view of the unforeseeable development of the prevailing variants in the coming months. 

Watzl said about the BA.1 booster: Clinical data is available, the preparation has been tested on several hundred subjects.

The antibody reactions were compared with a control group that had received the previous vaccine a fourth time.

“You saw significantly more antibodies against the omicron variant in people with the adapted vaccine – in young people as well as in old people, as in those who have recovered.” Anyone who is over 60 years of age and has previously waited with the fourth vaccination is for them now the opportunity.

Watzle also warned politicians against raising false hopes with the adapted vaccines – Corona cannot be vaccinated with that either.

The aim is better protection against omicrons - and above all against the disease, because protection against the infection will only be temporary after the vaccination, said Watzl.

"If you peddle it now on a large scale and call on everyone to get the vaccination, you're repeating the mistakes of last year."

Virologist Henrik Streeck was skeptical shortly before the EMA decision.

In his opinion, a booster vaccination, whether against BA.1 or the original variant, protects against a severe course of an infection.

Streeck therefore does not consider vaccination with the adapted vaccine to be absolutely necessary.

"We will not get any better protection against the infection," Streeck is certain.

• Moderna

  : Adapted corona vaccine against omicron variant BA.4 and BA.5 approved in the US for ages 18 and older (since August 31, 2022)

• Biontech Pfizer

  : Adapted corona vaccine against the omicron variant BA.4 and BA.5 approved in the USA from 12 years of age

Corona in Germany: Which Omicron variants are currently circulating in Germany

According to the Robert Koch Institute (RKI), the wild type Sars-CoV-2, Alpha and Delta have been completely displaced in Germany.

This emerges from the RKI weekly report (as of August 28, 2022).

Omikron has been circulating in Germany since November 2021.

Omicron even surprised virologists - the virus variant has various mutations on the spike protein and tricks the immune system of vaccinated and recovered people.

It is also somewhat confusing in view of the further developed corona vaccines: various omicron sublines are now circulating.

The lines Omikron BA.1 to BA.5.

In the summer, BA.5 in particular caused an omicron wave in Germany.

Omikron BA.5 is currently dominant, as data from the RKI clearly show:

Corona autumn 2022: booster vaccinations and use of Paxlovid

In addition to vaccination, antiviral drugs for Covid patients should be available more easily and quickly in autumn 2022.

Federal Minister of Health Karl Lauterbach (SPD) has been promoting greater use of the drug Paxlovid for months.

The corona drug still hardly plays a role in Germany.

That should change, the Federal Government’s Corona Expert Council has now also demanded.