DAVAO CITY —The anti-coronavirus infection jointly developed by Pfizer and BioNTech is said to be 90% effective in preventing the virus.
In a press statement released on Monday, November 9, the pharmaceutical giants claim the vaccine is ongoing Phase 3 trials. The vaccine developer said the protection in patients was achieved seven (7) days after the second two doses and in 28 days after the first.
In the same statement it said:
- The vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis
- The analysis evaluated 94 confirmed cases of COVID-19 in trial participants
- The study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected
- Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November
- A clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints.
The statement was released as coronavirus cases are soaring across the world, and European stock markets and oil prices jumped on the news.
“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla, Pfizer Chairman and CEO.
“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 records, hospitals nearing over-capacity, and economies struggling to reopen. With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”
After a discussion with the FDA, the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases. Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC performed its first analysis on all cases.
The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, 7 days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule. As the study continues, the final vaccine efficacy percentage may vary.
The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide.
“I want to thank the thousands of people who volunteered to participate in the clinical trial, our academic collaborators and investigators at the study sites, and our colleagues and collaborators around the world who are dedicating their time to this crucial endeavor,” added Bourla. “We could not have come this far without the tremendous commitment of everyone involved.”
According to preliminary findings, protection in patients was achieved 7 days after the second of two doses, and 28 days after the first.
Vaccine czar and National Task Force Chief Implementer Carlito Galvez Jr said on Monday, November 9, that supplies of a Covfid-19 vaccine will most likely arrive in the Philippines by the end of 2021 or in early 2022, saying the supply will be in high demand as the market has been waiting for it.
In a press briefing with the Department of Health, Galvez said this was both the “realistic” timeline and “worst-case scenario” for when the country would receive doses for widespread vaccination.
“Realistically speaking, baka po end of the year (2021) or 2022 darating ang main bulk ng vaccines kasi nakita nating meron po tayong kakulangan sa supply dahil ang mga mayayamang country ay kinuha na po yung majority of production,” Galvez said. –Editha Z. Caduaya/Newsline.ph
