Pfizer and BioNTech Say Their Vaccine Is Even More Effective Than Anticipated | Coronavirus

Preliminary results unveiled 10 days ago suggested that this messenger RNA vaccine, which has yet to be approved by regulatory authorities, had an efficacy rate of 90%.

However, these results relate to the analysis of 94 people who contracted COVID-19 in the two groups formed for the study, one having received the two doses of the vaccine, the other a placebo.

The new results relate instead to 170 infected people: only 8 cases of COVID-19 were reported in the vaccinated group against 162 in that of participants who received a placebo.

Only one infected person in the vaccinated group contracted a severe form of the disease, compared to nine in the placebo group.

According to the two companies, the vaccine is more than 94% effective in people over 65, who are particularly vulnerable and more likely to develop a severe form of the disease.

Its effectiveness would also be constant uniform, regardless of the age, gender or ethnicity of the people who receive it.

Few side effects

The two biotechs claim that their vaccine is safe, and that it causes only mild or moderate side effects, which wear off quickly.

Only 3.8% of participants reported feeling tired after receiving it, which was the most frequently reported side effect, they say. 2% of participants reported headaches.

The Pfizer / BioNTech clinical study has 43,661 participants in the United States, Germany, Turkey, South Africa, Brazil and Argentina. All will be followed for two years.

The phase 3 clinical study being completed, Pfizer and BioNTech will be able to publish their complete data and thus undergo the peer review process, necessary to validate the results.

Regulatory authorities, including the United States Food and Drug Administration and Health Canada will also analyze the results.

We continue to advance at the speed of science to compile all the data gathered so far and share it with regulatory authorities around the world.

Dr Albert Bourla, President and CEO of Pfizer

Pfizer and BioNTech reiterate that they intend to apply for marketing authorization in a few days to the FDA.

The FDA could then give the green light to the marketing as early as December, a senior official of the US government operation for vaccines (Warp Speed), Moncef Slaoui, said on Monday.

Millions of doses to come

The two companies still plan to produce up to 50 million doses of the vaccine globally in 2020 and up to 1.3 billion doses in 2021.

Production will be carried out by Pfizer plants located in St. Louis, Andover and Kalamazoo, in the United States, and in Puurs, Belgium. BioNTech is also due to produce it at its facilities in Germany.

On Monday, American biotech Moderna announced that its candidate vaccine against COVID-19 was found to be 94.5% effective, after a preliminary analysis of the first 95 cases of the disease reported among participants in its phase 3 clinical study.

The study being conducted in the United States, where the disease is wreaking havoc, Moderna said he expected to be able to complete his study within 7 to 10 days, until about sixty others were declared among the two. groups of participants.

The candidate vaccines from Pfizer / BioNTech and Moderna both rely on novel messenger RNA (mRNA) technology, which relies on synthetic genes that can be generated and manufactured in weeks, and produced at scale faster than conventional vaccines.

The Trudeau government has set aside 76 million doses of the Pfizer / BioNTech vaccine and 56 million doses of the Moderna vaccine.

Everyone can’t wait to see the real data

These results constitute a good news, said Nathalie Grandvaux, director of the Research Laboratory on the Host Response to Viral Infections at the CHUM Research Center, stressing that the data from the study strengthen over time.

It nevertheless reminds us that caution is in order. We are still in the new way of announcing scientific data through press releases, which is a little dangerous., she observes.

I think everyone is eager to see in the scientific community to see the real data, to be able to analyze it and above all to see all the subtleties of being there..

Pfizer and BioNTech still provided a little more information in their announcement this morning than in that of last week, underlines Ms. Grandvaux, who is also a professor in the department of biochemistry and molecular medicine at the University of Montreal.

The important points that can be extracted from this press release are the distribution in terms of age, gender, race and ethnicity of the participants in the study., she says.

What they specify which is extremely important is that their percentage of efficiency does not seem to change based on these parameters. They particularly mention an identical effectiveness in adults over 65, who are the most vulnerable people. That is a very good point.

Nathalie Grandvaux, from the CHUM Research Center

case, and therefore the representation in each of these groups is necessarily lower. So, we will have to continue to accumulate data to ensure that there is no visible difference over time with these different groups of people “,” text “:” On the other hand, we get along that they have studied 170 cases, and therefore the representation in each of these groups is necessarily lower. So, we will have to continue to accumulate data to ensure that there is no visible difference over time with these different groups of people “}}” lang = “fr”>On the other hand, we agree that they studied 170 cases, and therefore the representation in each of these groups is necessarily lower. So, we will have to continue to accumulate data to ensure that there is no visible difference over time with these different groups of people., she adds.

The researcher also points out that the vaccine appears to have the same effects in people who had previously contracted COVID-19 as in those who had never been infected.

She notes, however, the lack of data on people who have diseases that affect their immune systems.

Nathalie Grandvaux finally recalls that it is normal for the duration of the immunity conferred by the vaccine to remain indefinite. That, we will find out as these patients continue to be followed., she says.

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