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The BNT162b2 vaccine jointly developed by Pfizer and BioNTech – Photo: medpagetoday.com
The COVID-19 BNT162b2 vaccine has been jointly developed by Pfizer Pharmaceutical Group in New York (USA) and BioNTech Biotechnology Company in Mainz (Germany).
In 10 clinical trials of the COVID-19 phase 3 vaccine around the world, the Pfizer-BioNTech partnership was the first to announce the test results on September 11 (local time).
According to the ad, the vaccine was 90% effective.
Initial results only, unpublished data
Pfizer said phase 3 of the BNT162b2 vaccine trial began on July 27 and has recruited 43,538 volunteers.
They were divided into two groups: 38,955 people received the vaccine in two injections and the other group received a placebo.
7 days after the second dose and 28 days after the first dose, the vaccine has started to appear.
The results of the temporary phase 3 analysis showed that the vaccine was more than 90% effective when comparing the number of participants infected with COVID-19 in the group that received the vaccine and the group that received a placebo.
This analysis was conducted after 94 participants became infected with COVID-19. Then it will determine how many infected people received the vaccine or a placebo.
Pfizer said this data has not been released because Pfizer wants to continue the clinical trial until it has determined that there were 164 positive cases of COVID-19. Furthermore, the data has not been published in any scientific journal.
In the press release, Mr. Albert Bourla, President and CEO of Pfizer, stated that this is “the first result of our Phase 3 COVID-19 vaccine trial” and “preliminary evidence.” on the ability of the vaccine to prevent COVID-19 “.
BNT162b2 vaccination trial for volunteers in Baltimore – Photo: AP
French scientists remain skeptical
Actually, French scientists are not in a hurry, but they are waiting for additional data.
Reply to the newspaper 20 minutesProfessor Daniel Floret, vice president of the Technical Committee on Immunization (under the High Level Health Authority), commented: “We have to wait for more accurate data. Pharmacies are always excited about it. But we cannot simply rely on a” statement from press”.
According to him, there are still many questions to be answered, such as that Pfizer says that vaccines are 90% effective, but how to explain this result? Do vaccines prevent infections effectively?
In fact, trials have shown that vaccines produce the immune response, but the immune response and the ability to prevent disease are not the same.
“The data should show how safe the vaccine is, because if the vaccine is effective, there is no question that it is safe and there are no side effects,” he explained.
Unless the data is published and analyzed by independent experts, caution should be exercised. Results from clinical trials must be submitted to many different pharmaceutical regulatory agencies for review.
Professor Gilbert Deray, Head of the Kidney Department at the Pitié-Salpêtrière Hospital in Paris, also has a similar cautious attitude.
He pointed out some questions like: How long does immunity last? What are the side effects? Can the vaccine prevent serious forms of COVID-19 infection? Do weakened patients have immunity?
Laboratory of the biotechnology company BioNTech in Germany – Photo: DPA
When will the vaccine really be effective?
The Pfizer Company assured that the Data Monitoring Committee (made up of independent experts) had not registered any serious safety issues and suggested that more data be collected and collected effectively.
“The data will be discussed with regulators around the world,” emphasized Pfizer.
Pfizer and BioNTech are expected to continue to test the effects of the BNT162b2 vaccine for two months after the second injection dose, and the test will be available by the third week of November 2020.
So if the vaccine is really effective and the US Food and Drug Administration (FDA) gives emergency approval, production is fast.
Professor Daniel Floret explained that vaccines based on RNA genetic materials like the BNT162b2 vaccine can easily be produced in very large quantities.
For many countries that have already placed orders, he noted, it is necessary to first discuss to whom the vaccine is provided.
Still, he assured: “Actually there will be many vaccines, not one, maybe in the second half of 2021. But we have to understand that it is impossible to vaccinate everyone for a few months. It takes time. It produced many billions of dose … “.
Pfizer and BioNTech announced plans to deliver 50 million doses by 2020 and 1.3 billion doses by 2021.
The European Union reached a preliminary agreement with Pfizer and BioNTech in September 2020 to order 300 million doses of the vaccine. It expects to buy 10 million doses, and the United States has contracted with Pfizer to supply it with 100 million doses.
Pfizer has prepared a cold storage of vaccines awaiting distribution in Kalamazoo, Michigan – Photo: PFIZER
