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Corona inactivated vaccine Novavax: Approval is pending - everything faster than expected?

2021-12-15T05:04:26.863Z


Corona inactivated vaccine Novavax: Approval is pending - everything faster than expected? Created: 12/15/2021, 05:55 AM By: Patrick Mayer Focus on dead vaccines: The Novavax corona vaccine is soon to be approved in the EU. A special procedure recently accelerated approval. Update from December 13th, 1:45 p.m .: Is it going much faster than expected? The so-called corona dead vaccine Nuraxovid


Corona inactivated vaccine Novavax: Approval is pending - everything faster than expected?

Created: 12/15/2021, 05:55 AM

By: Patrick Mayer

Focus on dead vaccines: The Novavax corona vaccine is soon to be approved in the EU.

A special procedure recently accelerated approval.

Update from December 13th, 1:45 p.m

.: Is it going much faster than expected?

The so-called corona dead vaccine Nuraxovid from Novavax could be recommended for approval by the European Medicines Agency (EMA) before the turn of the year.

According to the

Pharmazeutischer Zeitung (PZ),

the director for vaccination strategy, Dr.

Marco Cavaleri, known.

Approval could take place this year, he said.

With the corona vaccine, which is one of the protein vaccines, five vaccines would so far be available in the European Union (EU) and in Germany.

The manufacturer from the USA applied for approval in the EU on November 17th.

But: The EMA has been reviewing preclinical and clinical data on the vaccine in a so-called rolling review process since February, reports

Pharmazeutische Zeitung

further.

Corona dead vaccines: The vaccine Nuraxovid from Novavax is about to be approved in the EU

The Paul Ehrlich Institute, as the Federal Institute for Vaccines and Biomedical Medicines, describes such a “rolling review” as follows: Vaccine candidate is started before all the necessary data for a marketing authorization application have been collected. The formal application for approval can be submitted as soon as all the necessary data are available. "

In contrast to the Novavax vaccine, the products from Biontech / Pfizer and Moderna are mRNA vaccines and the vaccines from Astra-Zeneca and Janssen (Johnson & Johnson) are so-called vector vaccines. The weekly magazine

ZEIT

recently explained dead impurities in a simplified manner. In the case of classic live vaccines, for example, live pathogens are used, "whose disease-causing effects have been bred away in the laboratory, so to speak". It is then a matter of "pathogens that have been rendered harmless". In the case of dead vaccines, on the other hand, “only” structures are used, for example proteins from the pathogen surface, which, according to

ZEIT, are recognized

by antibodies and cells of the immune system. Sometimes pathogens are bred and then killed so that they can be administered as a whole “dead” virus. Then there is a so-called dead vaccine.

Apparently shortly before approval: the dead corona vaccine from US manufacturer Novavax.

© IMAGO / Pixsell

Corona dead vaccines: Some vaccine skeptics argue by waiting for this vaccine

First report from December 13th:

Gaithersburg / USA - The corona pandemic continues to rage, meanwhile Germany, Austria and Switzerland are struggling with a loud vaccination opposition.

Some skeptics argue that they should only be vaccinated if there is a dead vaccine * that is based on the classic procedure.

This argument cannot be substantiated with facts, but some skeptics are no longer receptive to facts.

Could the inactivated vaccine Novavax turn things around?

Corona: Why many are waiting for the dead vaccine

The Novavax vaccine is a so-called dead vaccine, which contains components of the novel coronavirus that have been killed for immunization. So far, only corona vaccines based on other methods have been approved in the European Union: The vaccines from Biontech / Pfizer and Moderna based on the new mRNA technology and the vector vaccines from Astrazeneca and Johnson & Johnson. Novavax is therefore of interest to people who have reservations about immunization with mRNA vaccines or vector vaccines. But there's another reason the Novavax could make a difference in fighting pandemics. Because Novavax - unlike the Biontech Pfizer vaccine, for example - can be stored at refrigerator temperature, the drug is considered a beacon of hope for poorer countries.

Novavax is a new vaccine against the coronavirus, Indonesia was the first country to approve it.

It is a so-called dead vaccine.

© Sven Simon / Imago

Novavax: When the vaccine could get approval

In November, Indonesia was the first country in the world to approve the inactivated vaccine Novavax, which was later approved in the Philippines.

In mid-November, the US pharmaceutical company Novavax applied for marketing authorization in the European Union.

At that time it was said that the decision would be announced in "a few weeks".

The manufacturer announced that its vaccine was 90 percent effective and 100 percent protected against moderate and severe disease.

At the beginning of August, the EU Commission signed a purchase agreement with Novavax on behalf of the member states for up to 100 million vaccine doses this year and next.

The contract also includes an option for 100 million more vaccine doses in 2021, 2022 and 2023. The German Ministry of Health is already planning the vaccine for next year.

That could be good news, because the manufacturer himself states that it is already adapting its vaccine to the new Omikron variant.

The pharmaceutical company has also applied for approval in Canada, Australia, Singapore, Great Britain and New Zealand.

Novavax wants to fix production problems with a new collaboration

Actually, Novavax wanted to go much further: The pharmaceutical company had planned to deliver several billion doses of the vaccine against Covid-19 in 2021. But production problems thwarted the company's plans. The pharmaceutical giant has already received 1.6 billion dollars in subsidies from the US government, but Novavax has repeatedly had difficulties complying with quality standards, as

Forbes

reports. A shortage of raw materials also affected production.

In November, Novavax boss Stanley Erck said in an interview with

CNN

that the company would shortly be forwarding the full data for an emergency approval to the US FDA. As soon as he gets the green light from the FDA, the first 100 million cans would be ready for shipping, the Novavax CEO added. But approval is only available for corporations that can deliver their funds without restrictions. According to its own information, the company wants to be able to produce more than two billion vaccine doses in 2022. After all, Novavax now has a strong partner at its side: According to a press release by the company, the pharmaceutical company now has the world's largest vaccine manufacturer on board with Serum Institute of India.



*

As Federal Health Minister Karl Lauterbach recently made clear via Twitter, the Novavax vaccine is not a dead vaccine.

As the company also states on its website, Novavax is a protein vaccine.

(afp / bm)

Source: merkur

All news articles on 2021-12-15

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