Health

Despite all the joyful dances: a vaccine is not yet for tomorrow

Now that Pfizer has announced that its vaccine is 90 percent effective, many are unlucky. But we will have to be patient, because there are still many hurdles to be overcome.

The American pharmaceutical giant Pfizer surprised the world on Monday. His corona vaccine in collaboration with the German BioNTech is 90 percent effective, interim results show. This makes it just less good than the measles vaccine, which claims 95 percent effectiveness. The flu shot only hits a maximum of 60 percent.

So a brilliant performance. And yet we should not immediately party the roof of the roof, “although there will have been a few people in the sector dancing on Monday,” says vaccineologist Isabel Leroux-Roels of UZ Gent. But a vaccine will not be until tomorrow. We list everything here.

What do these results mean for a potential vaccine?

They are already very hopeful. The protection would start 28 days after you have been vaccinated and be good for a long time. None of the participants also developed significant health problems during the trial.

But we must not forget that these are intermediate results on 94 subjects. Even though all experts are enthusiastic about what has been achieved so far, things can still change. The study covers a total of 164 patients and only once they have all been tested can Pfizer come up with final results. It will also show how long the vaccine protects you and whether there is a difference between young and old people. That data is not yet available.

At the end of November, the company would like to request accelerated approval from the American pharmaceutical watchdog FDA. This means that part of the vaccine is already being viewed while tests are still ongoing, so that approval can go faster afterwards.

“But this is mainly proof that all vaccines that target the so-called spike protein, which the virus passes on from person to person, work,” says Leroux-Roels. “Before it was unclear whether that was the right strategy, but now it appears that we are on the right track.” Moderna and Sanofi, among others, focus on the same protein.

What obstacles still have to be overcome?

First of all, Pfizer must collect enough data to submit the expedited approval. The FDA is asking for proof that the vaccine works, that it is safe and that it can be permanently produced to the same quality.

Pfizer now has the first results and there is little doubt about its safety, although the watchdog wants two months of data on the side effects. They could be there by the third week of November, after which the company would like to apply for approval immediately.

For the third criterion, CEO Albert Bourla claims that Pfizer “has invested at its own risk in expanding and improving its manufacturing processes since the start of the pandemic.” According to him, this proves that the vaccine can also be produced in the future in a high-quality manner in the company’s labs.

Most of the production takes place in the Pfizer factory in Puurs. Hundreds of thousands of bottles are already rolling off the line there.

When all those data have been submitted, it is especially important to carry out the rest of the tests as quickly but also as correctly as possible. And then we have to wait for the vaccine to be marketed. “But at this rate, Pfizer should have all the data before the end of this year,” says Leroux-Roels.

Do we now have a vaccine in Belgium soon?

The general consensus is that there won’t be until the beginning of next year. Belgium is not currently buying vaccines itself, but has already subscribed to European contracts with AstraZeneca and Johnson & Johnson. Soon an option will also be taken on the vaccine that Sanofi and GSK are developing together. Our country has not yet taken an option on the Pfizer drug, but talks with Europe about this are also ongoing.

They would be closed on Wednesday and the member states will receive information about this on Friday. On Monday, the Belgian medicines agency will give an advice, after which the ministers of Health will decide later in the week whether they will actually sign up for it.

But not everything has been arranged yet. From then on, we have to wait until the European Medicines Agency gives its approval for the vaccine, after which the European Commission must start distributing it among the member states. Belgium would receive about 7.4 million vaccines, but two are needed per person. So 3.7 million people, or a third of the population, can be vaccinated with it.

For the rest of the population, our country is counting on the other contracts. AstraZeneca will also provide 7.7 million vaccines, Johnson & Johnson will provide 5.2 million. Although they both have a much longer road to travel than Pfizer.

Of course, Pfizer will produce additional vaccines, but they cannot reach 1, 2, 3 in Belgium. They have to be kept at a temperature of -70 degrees Celsius, which will be a tough logistical challenge.

In addition, it will be difficult to keep it anyway. After all, not every doctor has a freezer at 70 degrees below zero. “That is why Pfizer is working hard to make the vaccine resistant to higher temperatures, but that will not be for immediately,” says Leroux-Roels. UZ Gent has already prepared itself by purchasing additional deep-freezing and will later use the containers that are now used as a test hub as a vaccination site.

Can we drop all the rules once there is a vaccine?

No. We will still have to persist for a while. Once the first deliveries are here, risk groups – such as healthcare workers, the elderly and weaker people – are given priority. If there are any vaccines left, the rest of the population can be vaccinated, but as it turned out above, there will never be enough vaccines from the start.

That is why it will be important to still keep your distance and wear face masks for the first few months. “We will be able to resume our normal life sometime in 2021, but that will not be before March”, Leroux-Roels concludes.

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