The company counted 170 cases of coronavirus infection among the volunteers who participated in the trial. He said 162 infections occurred in people who received placebo or plain saline injections, while eight cases were in participants who received the actual vaccine. That results in a 95 percent efficiency, Pfizer said.
“Efficacy was consistent across all age, race and ethnic demographics. Efficacy seen in adults over 65 was more than 94 percent,” Pfizer and its German partner BioNTech said in a joint statement.
An independent group has been keeping an eye on the results and side effects. “To date, the Data Monitoring Committee for the study has not reported any serious safety issues related to the vaccine,” the companies said.
“The only requested Grade 3 (severe) adverse event greater than or equal to 2 percent in frequency after the first or second dose was fatigue at 3.7 percent after dose 2,” the companies said. Older adults tended to have fewer adverse events and those who did were milder.
Pfizer to search the US ‘in a few days’
Pfizer said it will seek emergency use authorization from the US Food and Drug Administration “in a few days.”
“This data will also be sent to other regulatory agencies around the world,” said Pfizer. They also plan to publish the data in a peer-reviewed scientific journal.
“The rapid protection this vaccine provides, combined with its tolerability profile across all age groups studied so far, should help make this vaccine an important tool in addressing the current pandemic,” said Dr. Ugur Sahin, Director. executive and co-founder of BioNTech.
Pfizer said Nov. 9 that interim data provided initial evidence that the vaccine was more than 90 percent effective. That information was based on the first 94 cases of coronavirus infection among volunteers. The company said at the time that it would need to count more cases of infection in the trial before it could consider phase 3 of the trial complete and request clearance from the FDA.
The phase 3 clinical trial of the vaccine began on July 27. Pfizer said that of 43,661 volunteers enrolled, 41,135 have received a second dose of the vaccine or placebo. The FDA said it wanted at least two months of safety follow-up of the volunteers after receiving their second injections.
The companies also said they have tried to recruit a diverse group of volunteers to more closely match the groups most severely affected by the pandemic. “Approximately 42 percent of global participants and 30 percent of American participants are racially and ethnically diverse, and 41 percent of global participants and 45 percent of Americans are between 56 and 85 years old. age, “said Pfizer.
The 150 clinical trial sites in the United States, Germany, Turkey, South Africa, Brazil, and Argentina will continue to collect efficacy and safety information for two more years.
1.3 billion doses planned for 2021
“Based on current projections, companies expect to produce up to 50 million doses of vaccines globally in 2020 and up to 1.3 billion doses in 2021,” they said.
Pfizer has three vaccine manufacturing plants in the United States in St. Louis, Kalamazoo, Michigan, and Andover, Massachusetts, plus one in the Belgian town of Puurs. “The German BioNTech sites will also be leveraged for global sourcing,” the companies said.
Many states have raised concerns about the fragility of the Pfizer vaccine, which must be kept at minus 75 ° C, well below the capacity of standard freezers.
But the companies said their custom packaging would help.
“Pfizer relies on its vast experience, expertise, and existing cold chain infrastructure to distribute the vaccine around the world,” they said.
“The companies have developed specially designed temperature controlled thermal conveyors that use dry ice to maintain -70 ° C temperature conditions,” they added.
“They can be used as temporary storage units for 15 days by filling them with dry ice. Each shipper contains a thermal sensor with GPS to track the location and temperature of each vaccine shipment through its pre-established routes taking advantage of Pfizer’s extensive distribution network. . “
Vaccine maker Moderna released interim efficacy data on Monday showing its vaccine provided about 95 percent protection.
Both Moderna’s and Pfizer’s vaccines use a new, relatively unproven vaccine technology that uses genetic material called messenger RNA, or mRNA. The mRNA encodes a portion of the coronavirus spike protein, the structure it uses to adhere to the cells it attacks.
When injected into people, it causes some cells to produce small fragments of this spike protein, which the immune system recognizes and develops antibodies and immune cells to attack. So when a vaccinated person is exposed to the real virus, the immune system is already ready to quickly neutralize it.