In a major victory in the fight against the coronavirus, Pfizer Inc. announced that its experimental cure for COVID has a 90-percent efficacy against the virus. Pfizer and its German partner BioNTech SE released data from a large-scale clinical trial of a COVID vaccine. The companies said their experiments found no safety concerns in their third-phase clinical trials of the Pfizer vaccine.
The company expects emergency approval for the vaccine from the US regulatory authorities for use in people aged 16 to 85 authorities for use in people aged 16 to 85.
“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.”
Pfizer Vaccine Breakthrough
Pfizer, after discussion with the Food and Drug Administration (FDA) authority decided to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases. An external, independent Data Monitoring Committee (DMC) evaluated 94 cases in all.
The cases were split between people who received the vaccination and those who were given a placebo and results indicated a vaccine efficacy rate above 90%, at 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.
The DMC did not find any safety concerns and has recommended that the study continue. The data will be discussed with regulatory authorities worldwide. It has yet not been peer-reviewed or published in a journal, but will be once the additional tests are finished.
The Phase 3 clinical trial of BNT162b2 has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8, 2020, says a press statement from the company. The candidates are made up of racially and ethnically diverse backgrounds.
The study will extend to people who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease.
Pfizer and BioNTech have a $1.95bn contract with the US government to deliver 100 million vaccine doses from January 2021. Other countries with similar agreements include the European Union, the United Kingdom, Canada and Japan.
The companies expect to produce up to 50 million doses of the Pfizer vaccine, or enough to protect 25 million people this year.
The 90 % efficacy rate is well above the 50-percent effectiveness required by the FDA for a COVID vaccine.
Operation Warp Speed
In May, President Donald Trump announced Operation Warp Speed a government initiative to hasten the development of a vaccine with a year. Typically, vaccines take years to develop and pass all regulations to reach the market. Peter Hotez, a vaccine expert at the Baylor College of Medicine, says, vaccine developers should aim for 70–75 per cent efficacy.
The global race for a cure for COVID-19 has seen many countries go into multibillion-dollar supply deals with drugmakers like Pfizer, AstraZeneca Plc. and Johnson & Johnson.