Pfizer and BioNTech's coronavirus vaccine shows “encouraging” data, according to early tests

(CNN) The Covid-19 vaccine candidate being developed by the American pharmaceutical company Pfizer and the German biotechnology company BioNTech has returned positive data in early tests, according to data published by the companies.

The companies announced these preliminary findings Wednesday in a preprint document showing that participants in a Phase 1/2 study of the vaccine, called BNT162b1, responded to the immunization and was found to be well tolerated. The Phase 1/2 study is ongoing. The data has not yet been published in a peer-reviewed medical journalBrazil will buy vaccines against covid-19 0:43

“These clinical findings for the BNT162b1 RNA-based vaccine candidate are encouraging and strongly support accelerated clinical development and at-risk manufacturing to maximize the opportunity for rapid production of a SARS-CoV-2 vaccine to prevent COVID-19. XNUMX″, the researchers wrote in the preprinted document, sponsored by BioNTech and designed by Pfizer.

For the initial study, 45 participants between the ages of 18 and 55 were randomly assigned to receive a given dose of the vaccine or placebo. Twelve participants received two 10-microgram doses 21 days apart; 12 received two 30-microgram doses 21 days apart; 12 received a single 100 microgram dose on the first day; and nine received a placebo, according to the study.

In the seven days after the vaccine injection, some participants who received one dose reported pain at the injection site, fever or sleep disturbances, but “no serious adverse events were reported,” according to the document.

The researchers found that the vaccine generated antibodies against coronavirus in all participants 28 days after receiving a single 100 microgram injection or seven days after receiving a second dose of 10 or 30 micrograms

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“These preliminary data are encouraging, as they demonstrate that BNT162b1 exploiting the SARS-CoV-2 RBD as a target antigen is capable of producing neutralizing antibody responses in humans at or above the levels observed in convalescent sera, and that It does at relatively low doses levels. “We look forward to providing further data updates on BNT162b1,” Dr. Ugur Sahin, CEO and co-founder of BioNTech, said in a company news release on Wednesday.

Pfizer and BioNTech announced Wednesday that this preliminary data will help them determine a dose level for the vaccine and then select which of their multiple vaccine candidates will advance to a larger-scale global Phase 2/3 study, possibly beginning as soon as this month.

“We are encouraged by the clinical data of BNT162b1, one of four mRNA constructs we are evaluating clinically, and for which we have positive, preliminary, top-line findings,” said Kathrin Jansen, senior vice president and head of vaccine research and development. at Pfizer.

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“We are dedicated to developing potentially innovative vaccines and medicines, and in the face of this global health crisis, we approach this goal with the utmost urgency,” Jansen said. “We hope to publish our clinical data in a peer-reviewed journal as quickly as possible.”

According to World Health Organization, there are 17 coronavirus vaccine candidates in clinical evaluation worldwide.