According to a CNN report at 11:45 GMT on November 9th, the pharmaceutical company Pfizer Pharmaceuticals (hereinafter referred to as “Pfizer”) said on Monday that an early analysis of its Coronavirus vaccine data showed that the effectiveness of the vaccine exceeded 90%, if this trend continues, its effect will be much better than expected.
The so-called interim analysis is to study 94 confirmed cases of Coronavirus more than 43,000 volunteers who received two doses of vaccine or placebo. The study found that less than 10% of infections came from vaccinated participants, and more than 90% of cases came from participants who received a placebo.
Pfizer stated that the vaccine began to provide protection 7 days after the second dose and 28 days after the first dose. The ultimate goal of the experiment is to study 164 confirmed cases of Coronavirus.
In the press conference, Pfizer stated that in accordance with FDA (U.S. Food and Drug Administration) requirements, when volunteers receive the second dose of the vaccine and monitor it for two months, they will apply to the FDA for emergency use.
Pfizer said they expect to reach this goal in the third week of November.
Since July 27th, 43538 people have participated in the Phase III clinical trial of the vaccine developed by Pfizer and BioNTech in Germany. As of last Sunday, 38,955 people had received the second dose of vaccine. The company claims that 42% of international test sites and 30% of US test sites include volunteers of different races and nationalities.
Pfizer CEO Albert Bourla said in a statement that we have taken an important step in providing breakthroughs for people around the world to end this global health crisis. In the coming weeks, we will share a lot of volunteers. More effectiveness and safety data for the authors.
Pfizer said that it has added a second node to the study, which will evaluate whether the vaccine can help people withstand severe Coronavirus and whether the vaccine can provide long-term protection against Coronavirus, even if the person has been infected.
The FDA has stated that the effectiveness of any vaccine should not be less than 50%.
According to previous reports by The Paper, Pfizer announced on its website that it has obtained FDA approval to include adolescents as young as 12 years old in the trial.
CNN reported on October 15 local time that Pfizer plans to carry out a Coronavirus vaccine experiment among young people as young as 12 years old. Parents have expressed interest in their children joining.
Dr. Robert Frenck Jr., director of the Cincinnati Children’s Hospital Vaccine Research Center, said that this week, a team at the hospital has begun vaccinating young people aged 16 and 17, and will recruit young people aged 12 to 15 later. Other sites will also Recruit minors.
Pfizer is one of the first four companies to conduct Phase III trials of the Coronavirus vaccine in the United States. According to Pfizer’s official website, the Phase 2/3 clinical trial of the mRNA vaccine developed by Pfizer and BioNtech of Germany has begun in late July.
Pfizer’s official website announced that, if approved or authorized by the regulatory authorities, the global production capacity of the two companies is expected to reach 100 million doses by the end of 2020 and may reach 1.3 billion doses by the end of 2021.
According to previous reports by The Paper, my country has 4 vaccines that have officially entered the phase III clinical trials. Among them, the two inactivated vaccines developed by Sinopharm Group have been included in the scope of emergency use.
In addition, according to the private vaccine company Chongqing Zhifei Biological Products Co., Ltd. announced at the end of October, its wholly-owned subsidiary Anhui Zhifei Longkoma Biopharmaceutical Co., Ltd. and the Institute of Microbiology of the Chinese Academy of Sciences jointly developed a recombinant new coronavirus vaccine (CHO cell).
The data of Phase II and Phase II clinical trials show that its safety and immunogenicity are good, and Phase III clinical trials are being prepared.