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, Nov. 9 (Xinhua) -- U.S. pharmaceutical company Pfizer said on its official website that its first mid-term analysis of the phase III trial of the new crown vaccine, developed in partnership with German biotech company BioNTech, showed that the vaccine was more than 90 percent effective.
the scientific community is cautiously optimistic about the results. Pfizer's message did not say whether the vaccine and other similar vaccines could prevent new cases of severe cases or quell new crown outbreaks.So far, more than 43,000 healthy volunteers have participated in phase III clinical trials with Pfizer and BioNTech, and after volunteers were given two doses of the vaccine or placebo, the researchers studied 94 newly confirmed cases and found that less than 10 percent of them were vaccinated and more than 90 percent were placebo recipients.
said the vaccine began to provide protection seven days after the second dose and 28 days after the first dose. "Our Messenger RNA (mRNA) vaccine can help most patients prevent new crowns, which means we're taking an important step forward in researching breakthroughs to end this global health crisis for people around the world." Albert Bourla, the company's chief executive, said in a statement.
vaccine, developed by the two companies, includes molecular instructions for human cells in the form of mRNA to make coronavirus tingling proteins, a key target for the immune system against coronavirus. Two doses of the vaccine have shown promising prospects in animal studies and early clinical trials. Phase III clinical trials of the vaccine began on July 27.
"If this number really works, it will work very well, better than I expected," he said. Ashish Jha, dean of brown university's School of Public Health and not involved in the study, said. The U.S. Food and Drug Administration (FDA) requires the threshold for the use of coronavirus vaccines approved in emergency situations to be 50 percent effective.
, Pfizer's figures are not final and have not been peer-reviewed by outside experts or published in medical journals. "How effective the vaccine is will be until Phase III. Clinical trials are completed, and there will be sufficient data analysis." Chen Gang (a natural name) of the Professional Committee on Virology of the Chinese Society of Microbiology told the China Science Daily., Pfizer's disclosure lacks details of how the vaccine can prevent infection. "I want to know what level of infection this vaccine can prevent." Paul Offit, a member of the FDA's advisory board, said.
missing detail is how effective the vaccine is in different groups of test participants. "We don't yet know if it works in older people who need the vaccine most." Florian Krammer, a virologist at mount Sinai's Icahn School of Medicine, said. Offit said Pfizer's trial is unlikely to determine the effectiveness of the vaccine among people over 65 or African-Americans, as only small cases accumulate before the end of the trial.
Pfizer aims to record 164 infections in all volunteers to demonstrate compliance with FDA guidelines. "We're not going to apply for FDA emergency use authorization based on current treatment results alone, we need more data on safety." Bourla said.
remains an open question: how long can vaccines last, even if they work? Some have compared the duration of the new crown vaccine to that of the flu vaccine, saying it can only last for a few months. In this regard, Chen Gang said, from the mutation situation, the influenza virus mutates too fast, and the current new coronavirus mutation is slower, its continuity is longer than the flu.Jinghua, a researcher at the Institute of Microbiology in Shanghai, told China Science that it was too early to tell how long the global new crown vaccine would last because it was still too short to develop. "Whether or not these vaccines are safe, effective and for how long, it depends on the final clinical trial results.", one thing is certain about the Pfizer vaccine: regulators will soon decide whether it can be rolled out. The company said it would seek emergency approval from the FDA around the third week of November, when participants will be tracked for an average of two months -- a safety requirement for the new crown vaccine.
Phase III vaccine trials are a necessary and critical final step in obtaining a vaccine distribution license. Pfizer is the latest of four companies in the U.S. to conduct phase III trials of the new crown vaccine. The other three are Johnson and Johnson, AstraZeneta and Modner.
In vaccine research and development, China has parallelly promoted the inactivated vaccine, adenovirus vector vaccine, recombinant protein vaccine, nucleic acid vaccine, anti-virus influenza vaccine and other 5 technical routes of research and development, there are currently 11 vaccines into the clinical trial stage, of which 4 have entered Phase III clinical trials. Of the four vaccines, two inactivated vaccines developed by The National Pharmaceutical Group have been included in the scope of emergency use.
Chen Gang introduced, the domestic III. phase of the new crown vaccine clinical data at the earliest until the end of the year or early next year to have results, most of the current emergency use, priority given to health care and other front-line staff.
At present,
Microbiology Research Institute and the private vaccine enterprise Chongqing Zhifei Biological Products Co., Ltd. developed recombination of the new coronavirus vaccine (CHO cells) Phase I, Phase II clinical trial data show that its safety, immunogenicity is good. "At the moment, we are just starting Phase III clinical trials abroad because of the better control of the domestic outbreak and the lack of related cases." Yan Jinghua said.
since November 9, local outbreaks have been reported in Shanghai and Tianjin. In this regard, Chen Gang believes that china's new crown outbreak risk is one is a continuous external input, the other is sporadic local discovery, even small-scale outbreaks, but under the current prevention and control measures, large-scale outbreak epidemic is unlikely. "We need to have confidence in the effective control of our country." He said.