Friday, December 4, 2020

When is there a vaccine?


 Every day there are reports about new vaccines against the corona virus SARS-CoV-2. But nobody has been admitted yet. In the long run, it boils down to multiple vaccines anyway.

The first vaccinations are allowed, they have been applied for elsewhere:

The UK granted Pfizer and Biotech’s mRNA vaccine emergency approval on December 2nd. An application for emergency approval has been submitted to the US FDA and the European Medicines Agency for conditional approval. The EU authority wants to decide on the vaccine on December 29th - this decision also applies to Germany.

A committee will meet on December 11th to discuss the approval of the mRNA vaccine from the US Company Moderna and to decide on approval.

The third, well-advanced vaccine candidate comes from the pharmaceutical company AstraZeneca. The company speaks of a protective effect of more than 70 percent. This vaccine candidate is a so-called vector vaccine (see below). Approval has not yet been applied for. The phase 3 study has not yet been completed.

First vaccinations December 2020 or January 2021

The protective effects of these vaccine candidates would be well above the minimum requirements of the World Health Organization (WHO), which required a protective effect of at least 50 percent. Two vaccinations are necessary for adequate vaccination protection. Relevant health complications or serious side effects as in other vaccine studies have not occurred so far.

But: So far these are only the first interim results, which are only available in the form of a press release. The effectiveness for different age groups, especially the elderly, has not yet been clearly clarified. However, it is unclear on how many observed cases this is based and thus whether it is statistically meaningful.

Even now long-term consequences can still occur, which have to be tracked and documented by the health authorities and which will be included in the approval process. In Europe there is a so-called rolling review, where data has been submitted continuously since the studies began.

Chinese vaccines have been in use for a long time

In China, vaccines have been conditionally approved since July and, according to the Chinese company Sino harm, have already been administered to more than a million people. Data from the important phase 3 study are not yet available. The Chinese vaccine also received emergency approval in Saudi Arabia, where clinical trials are also taking place.

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