When will a vaccine against Covid-19 come? Probably not until the beginning of 2021. The production of vaccination doses is in full swing.
At the gold mine is the name of the street in Mainz, where a company is doing what many are waiting for: At the biotechnology company BioNTech, production of the corona vaccine BNT162b2 has started on a large scale. The Karlsruhe logistics center of the partner company Pfizer, a US pharmaceutical giant, has been converted to be able to store hundreds of millions of vaccine doses at minus 70 degrees.
This is a “supranational task”, says a BioNTech spokeswoman: In Germany only the starting material of the vaccine is produced, mRNA genetic material, which is supposed to dock on human immune cells in order to teach them to add antibodies against the Sars Cov-2 virus form. In Austria, the mRNA is packaged in small fat globules; in Belgium, not far from the EU Parliament, the vaccination bottles are filled.
Pfizer / BioNTech wants to produce 100 million vaccine doses in Germany and the USA by the end of the year, and 1.3 billion next year – logistics will require dozens of freight flights and hundreds of truck trips every day, writes the newspaper Wall Street Journal and quoted Tanya Alcorn, Deputy Head of Logistics at Pfizer, as saying: “It’s the biggest vaccination campaign of all time.”
The federal government also reacts: How image reports, the federal government is demanding the addresses of vaccination centers from the federal states by November 10 so that they can be equipped with refrigerators. This is necessary for long-term storage of the vaccines; BioNTech’s should be stable for five days at refrigerator temperature. A spokeswoman for Spahns does not want to comment. The Standing Vaccination Commission in Germany is already working out plans for where the vaccines should be used first.
So far no effectiveness has been proven
So there is clear progress, because a number of other manufacturers such as the British AstraZeneca or the US Moderna are in a similar phase of development as Pfizer and BioNTech. Sounds encouraging, but unfortunately it does not help at all to suppress the currently skyrocketing infection curve (11,242 new infections recorded and 49 deaths in Germany, as of Friday). Across Europe, the number of cases doubled within ten days.
So far, no vaccine has been proven to be effective – not even the six substances approved by China and Russia. The trick there: States simply skipped the result of the third and crucial tier of clinical tests and pre-vaccinated military and medical personnel. The approvals were therefore made without sufficient research into the effects and side effects.
Such an approach would be unthinkable in the USA and in the EU. The US Food and Drug Administration (FDA) and the EMA (European Medicines Agency) make the decisions here. Former FDA public health officer Peter Lurie wrote in the September Washington Postthat generally only around half of vaccines that reach phase 3 are approved in the end.
For some, Facebook founder Mark Zuckerberg is “the most dangerous person in the world”. Because his platform drives people apart and promotes populism. How dangerous is that for democracy? – in the taz on the weekend of 24./25. October. In addition: The capital airport BER is ready! But the timing is pretty bad. And: three tips that will keep us warm outside in Corona autumn and winter. Always from Saturday at the kiosk, in the eKiosk or with a practical weekend subscription. And around the clock on Facebook and Twitter.
In 8 of the 22 case studies he examined, unexpected health risks arose in this last phase.
Vaccines in early 2021 at the earliest
Over the past week there have been seemingly conflicting reports from both sides of the Atlantic about when the first vaccines might be available.
The EU Commission had spoken of months, Federal Research Minister Anja Karliczek from mid-2021, Health Minister Jens Spahn was loud image internally allegedly claimed that the first vaccinations could be given this year – this was also heard from the USA. Spahn had his spokeswoman corrected on Friday: at the beginning of next year at the earliest.
On closer inspection, the reports do not contradict each other so strongly, at least they are all based on interpretations of the same facts in the USA and the EU.
Lembit Rägo is director of the council for international medical science organizations. He writes to the taz: “In essence, the scientific assessments of vaccine candidates hardly differ on both sides of the Atlantic.” The USA could soon issue an emergency license for vaccines, the Europeans a provisional marketing authorization. Both are roughly the same and only possible if, as is currently the case, there is a health emergency.
This also means that in this case “less information is available than would be expected with a normal marketing authorization for a vaccine,” writes the EMA of the taz. The general rule of thumb is that the benefits of vaccination must outweigh the risks.
BioNTech is testing in the crucial third phase
In the EU this means in concrete terms: The pharmaceutical company BioNTech is testing its vaccine in the crucial third phase on 37,000 test subjects worldwide, at the beginning of October 28,000 of them had already received their second vaccination dose. If the data of at least 3,000 of them have been evaluated and there are no unexpected side effects within six weeks of the second vaccination, the vaccine is considered safe, preliminary. In the USA, the vaccine must also have worked in at least half of the participants.
Several manufacturers will soon have enough data for the authorities to assess this. For the USA, Pfizer has announced that it will apply for an emergency license in the third week of November. The EMA has been reviewing the vaccine data from the British manufacturer AstraZeneca and BioNTech since the beginning of October, but not yet from the third clinical phase.
This means that soon enough clinical data will be available in the USA and therefore also in Europe. The assessment could then go very quickly: For example, the EMA promises a processing time of two weeks for each step of the approval in its “rolling review” procedure.
So it is very possible that a vaccine or two will be approved as early as December. The decisive question is then: How to deal with the fact that it would only be an approval based on the fact that “the advantage of immediate availability exceeds the risk of a limited data situation”, as the EMA writes?
Admission can be withdrawn at any time
The approval can be withdrawn at any time if the situation changes with the evaluation of the entire clinical tests. It would be impossible to imagine what would be going on if you were to throw a vaccine on the market and then cash in again because of unexpected side effects. The trust in the population would probably be gone.
The risk is there, according to an online hearing of FDA experts * on Thursday: Even after final marketing authorization, unexpected side effects can occur. Some are so rare that they do not even appear in large clinical studies, others only after a long period of time. No data are yet available for risk groups such as pregnant women.
It is a question of public expectation management whether politicians allow themselves to be carried away in the face of the situation into proclaiming an imminent success – or whether they are cautious in order not to arouse false hopes. This week, the head of the Robert Koch Institute, Lothar Wieler, gave the Socratic answer to a journalist’s question as to when there is a vaccine: “That is a question that we all cannot answer correctly.”