Pfizer and Biontech announce success in a clinical trial of a corona vaccine - 90 percent effective

This follows an interim analysis of a clinical trial that is in progress, in which it was found that out of 94 confirmed corona cases among the experimenters, only nine received the vaccine and the rest are from the control group that received a placebo

Pfizer and Biontech announce success in a clinical trial of a corona vaccine that proved 90 percent effective in preventing infection with the corona virus.

The data came from an interim analysis of an ongoing clinical trial, in which it was found that out of 94 confirmed corona cases among the experimenters, only nine received the vaccine and the rest were from the control group who received a placebo.

“The vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants with no evidence of prior SARS-CoV-2 infection in the first efficacy analysis. After the vaccine was given, 94 of the participants in the experiment got sick, the vast majority of them from the group that received the placebo, while only nine participants got sick in the group that received the real vaccine, which means, according to the company, it is a ninety percent effectiveness." said in the company's announcement.

Pfizer adds that 43,538 participants with diverse backgrounds participated in the study, and no serious safety concerns were observed; Additional safety and efficacy data continue to be collected.

The company intends to obtain emergency use authorization (EUA) for the American Food and Drug Administration - FDA immediately after achieving a milestone required to demonstrate safety, which is expected to occur in the third week of November.

Pfizer will continue the clinical trial in 164 confirmed cases in order to collect additional data and characterize the performance of the vaccine candidate against the control group. The studies were reviewed by an external committee of experts who monitored the clinical research data and reached this conclusion on Sunday this week - November 8, 2020.

CEO of Pfizer: "A great day for science and humanity"

"Today is a great day for science and humanity. The first set of results from the Phase 3 vaccine trial provides the initial evidence of our vaccine's ability to prevent infection with COVID-19," said Dr. Albert Borella, Chairman and CEO of Pfizer. "We are reaching this critical milestone in our vaccine development program at a time when the world needs it most, with infection rates setting new highs, hospitals nearing overcapacity and economies in need of reopening. With today's news, we are taking a significant step toward being able to provide people around the world with the breakthrough needed to help end this global health crisis."

"We look forward to sharing additional efficacy and safety data from thousands of participants in the coming weeks." After a discussion with the FDA, the companies recently chose to cancel the interim analysis of 32 cases and conduct the first interim analysis on a minimum number of 62 cases. With the conclusion of these hearings, the number of cases reached 94 and the DMC conducted its first analysis of all cases. The experimenters were divided into two groups, one that received the vaccine and the other that received a placebo, the findings show that the vaccine effectiveness rate is over 90%, seven days after receiving the second dose. This means that the participants in the vaccine trial were protected 28 days after the start of receiving the vaccine, which consists of two doses.

Pfizer emphasizes that as the research continues, the final effectiveness percentage of the vaccine may change. DMC reported no serious safety concerns and recommends that investigators continue to collect additional safety and efficacy data as planned. The data will be presented to regulatory authorities around the world.

In a statement issued by Pfizer and Binotech, it was stated that the phase 3 clinical trial of the vaccine - BNT162b2 began on July 27 and 43,538 participants participated, 38,955 of whom received a second dose of the vaccine candidate as of November 8, 2020. About 42% of the participants worldwide and 30% of the participants In the US they have a diverse racial and ethnic background. The trial continues until we have analyzed the data of all 164 confirmed COVID-19 cases. The study will also evaluate the vaccine candidate's potential to provide protection against COVID-19 to those who have been exposed to the virus but have not yet developed symptoms as well as the impact on rates of severe morbidity.

The evaluation of the data of the trial COVID-19 confirmed cases accumulated from 7 days after the second dose, in the final analysis approved by the FDA we will examine the effect of the vaccine 14 days after the second dose.

"Pfizer and Biontech continue to accumulate safety data and estimate that it will take about two months of collecting safety data following the second (and final) dose of the vaccine candidate - and to reach the amount of safety data required by the FDA in its guidance for possible approval for emergency use, by the third week of November. In addition, participants will continue to be monitored for long-term protective effect and safety for an additional two years after receiving their second dose."

"Along with the efficacy data generated from the clinical trial, Pfizer and Biotech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the manufactured vaccine product. Based on current forecasts we expect to produce worldwide up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021."

According to these data, if (theoretically) the other companies and bodies developing vaccines fail, it will be possible to vaccinate during 2021 only about 600 million people, out of the earth's population of about eight billion people, and allow a full return to normality in only about a decade.

Pfizer and Biotech plan to submit data from the full Phase 3 trial to a peer-reviewed scientific publication.

to Pfizer's announcement

More of the topic in Hayadan:

• A fourth clinical trial of a corona vaccine begins in the United States
• Israeli scientists have identified 23 new protein sequences in Corona * 3M contributed to the development of a vaccine at Tel Aviv University
• When will there be a vaccine for the corona virus? Four scenarios
• A cocktail of nano-antibodies produced from the animal will succeed in stopping the corona virus efficiently and at low cost