Vaccine Trials Complete, Shot 95% Effective: Pfizer
American drug giant Pfizer on Wednesday said that final results from the late-stage trial of its coronavirus vaccine was found to be 95 per cent effective and had no serious side effects on older people.
The findings are based on two doses given to more than 41,000 people around the world, said the US drugmaker adding that it would apply for emergency US authorisation soon, raising hopes that a working vaccine could soon become a reality.
This comes after Pfizer and its partner German biotechnology firm BioNTech had last week published data that their vaccine offered 90 per cent protection from the infection as compared to placebo saline shot.
The findings follows the announcement by US biotech company Moderna, which had on Monday released preliminary data from late-stage clinical trials for its vaccine, which it said proved to be 94.5 per cent effective.
In a statement today, Pfizer and BioNTech said they expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.
The vaccine prevented mild and severe forms of Covid and it was 94 percent effective in older adults, who are more vulnerable to developing severe Covid-19 and who do not respond strongly to some types of vaccines.
The findings were based on evaluating 170 cases of Covid-10 in volunteers, with just eight in the group given the vaccine and the remaining being administered a placebo shot of saltwater.
Dr. Albert Bourla, Pfizer’s chief executive, said in a statement, “The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic.”
According to a statement by Pfizer, “the efficacy was consistent across age, gender, race and ethnicity demographic. The observed efficacy in adults over 65 years of age was over 94 per cent.”
The most common serious adverse event was fatigue, with 3.7 per cent of volunteers reporting tiredness after they took the second dose. Two per cent of volunteers reported a headache after the second dose. Older adults reported fewer and milder side effects
Besides, Pfizer said it was ready to submit to the FDA two months of safety data that the agency had recommended. The FDA will review the data and ask an outside panel of vaccine experts to weigh in on the application, a process that could take weeks, the New York Times said.
“The vaccine must be stored at minus 94 degrees Fahrenheit, colder than any other vaccine in development. Pfizer will ship the vaccine in special boxes of 1,000 to 5,000 doses that are stuffed with dry ice and equipped with GPS-enabled sensors. Pfizer’s vaccine can be stored in conventional freezers for up to five days, or in the special coolers for up to 15 days, as long the dry ice is replenished and the boxes are not opened more than twice a day. Moderna’s vaccine must also be stored in a freezer long-term, but at minus 4 degrees Fahrenheit,” NYT further stated. (ANI)