The biotech company Pfizer said Wednesday that a full study of its experimental COVID-19
The vaccine was shown to be 95% effective. Pfizer said the vaccine did not have serious side effects and that the company will request emergency use authorization from US regulators in a matter of days.
“The study results mark an important step in this historic eight-month journey to present a vaccine capable of helping end this devastating pandemic,” said Albert Bourla, CEO of Pfizer.
The drug maker said the efficacy of the vaccine developed with German partner BioNTech SE was consistent across age and ethnic demographics, and there were no major side effects, a sign that immunization could be used widely across the world. world. Efficacy in adults over 65, who are at particular risk from the virus, was greater than 94%.
The final analysis comes just a week after the initial trial results showed the vaccine to be more than 90% effective. Moderna Inc released preliminary data for its vaccine on Monday, showing similar effectiveness.
Better-than-expected data from the two vaccines, both developed with new technology known as messenger RNA (mRNA), have raised hopes of ending a resurgent pandemic that has killed more than 1.3 million people worldwide. and it has wreaked havoc on economies and daily life.
However, while some groups, such as healthcare workers, will have priority in the United States for vaccines this year, it will be months before large-scale deployments begin.
Pfizer said there were 170 cases of the disease in its trial out of more than 43,000 volunteers, of which 162 were seen in the placebo group and 8 in the vaccine group. Ten people developed severe COVID-19, one of whom received the vaccine. He also said that the vaccine was well tolerated and that the side effects were mostly mild to moderate and disappeared quickly.
The only serious adverse event that affected more than 2% of those vaccinated was fatigue, which affected 3.7% of recipients after the second dose. Older adults tended to report fewer solicited and milder adverse events after vaccination.
The results come as the virus spreads rampant in the US, Europe and elsewhere, putting enormous pressure on healthcare systems with a record number of new cases and hospitalizations.
The arrival of winter in the Northern Hemisphere along with the Christmas season is expected to worsen the number of cases as people spend more time indoors and gather for family gatherings.
“With hundreds of thousands of people around the world infected every day, we urgently need to bring a safe and effective vaccine to the world,” Bourla said.
Pfizer and BioNTech also said they plan to submit the data to other regulatory agencies around the world and in the US They also plan to submit data from the study to a peer-reviewed scientific journal.
Pfizer reiterated that it expects to produce up to 50 million doses of vaccines this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.
Of the dozens of pharmacists and research groups competing to develop vaccines against COVID-19, the next data release will likely be from AstraZeneca Plc with the University of Oxford in November or December. Johnson & Johnson says it is on track to release data this year.
US Delivery Pilot Program
Pfizer has also launched a pilot program to deliver its experimental vaccine in four US states Vaccines must be shipped and stored at -70 degrees Celsius, significantly below the standard for vaccines of 2 to 8 degrees Celsius.
“We are hopeful that the results of this vaccine delivery pilot will serve as a model for other US states and international governments as they prepare to implement COVID-19 vaccine programs, “Pfizer said in a statement Monday.
He chose Rhode Island, Texas, New Mexico and Tennessee for the program after taking into account their differences in overall size, diversity of populations, immunization infrastructure, and the need to reach people in diverse urban and rural settings. The four states will not receive vaccine doses earlier than other states under the pilot, nor will they receive any differential consideration, Pfizer said.
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