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Original caption: Regulators struggled to approve or not, 17 votes to 4 votes for new Pfizer crown vaccine
Text | “Finance” intern Li Liping and reporter Wang Xiao
At 6:50 p.m. EDT on December 10, 2020, Pfizer and BioNTech announced that their new jointly developed corona vaccine, following a vote by a committee of experts from the US Food and Drug Administration The USA (FDA) recommended the approval of the emergency application of this vaccine. Authorization.
With 17 votes to 4 votes, the U.S. FDA Vaccine and Related Biological Products Advisory Committee (VRBPAC) finally approved the COVID-19 mRNA vaccine (BNT162b2), and medical staff and institutional residents long-term care providers can become priority vaccinators. .
“This is a new technology. There has not been a vaccine application of this technology before. This is the major concern of the US FDA.” Yu Wenzhou, chief physician of the Immunization Planning Center of the Chinese Center for Disease Control and Prevention, analyzed the Caijing reporter.
Once the US FDA decides, administration of the vaccine can begin within a few hours. The U.S. Centers for Disease Control and Prevention (CDC) has also provided states with an outline, recommending that first-line medical personnel and high-risk patients be given priority, but states can distribute vaccines as you see fit.
They have not reached the end
Regarding the question of “whether the benefits of this vaccine for people 16 years and older outweigh the risks of its use”, 17 of the 23 members of VRBPAC voted in favor of recommending the vaccine, 4 voted against and 1 abstained.
“The US FDA is really entangled in whether or not to approve vaccines. Its advisory committee recommends that the Pfizer vaccine be approved for emergency use only in high-risk occupations and populations. To approve national immunization such as the from the UK, it will take at least April of the following year. Collect clinical safety data for at least six months, “commented a public health professional in the circle of friends.
Before the voting results were announced, final data from the phase III clinical trial of this mRNA vaccine was published in the New England Journal of Medicine. On December 10, Pfizer also reiterated in the announcement that its Phase III clinical data showed that among participants without SARS-CoV-2 infection, the effective rate of the vaccine was 95%.
Among the 36523 subjects, only 8 cases were diagnosed with new coronary pneumonia in the vaccination group 7 days after the second injection of the vaccine, while there were 162 cases in the placebo group. These data are the source of 95% of the protective efficacy of the vaccine.
So far, this vaccine has rarely experienced serious vaccine-related adverse events (about 1%). However, from far away in the UK, people with a history of allergies have reported allergic reactions after being injected with this vaccine.
On December 2, the British Medicines and Health Products Administration (MHRA) approved Pfizer / BioNTech’s emergency use authorization for this mRNA vaccine, and a large-scale vaccine was launched on December 8.
However, at least two adverse reactions occurred on the first day of the vaccination program, including fatigue, headache, muscle pain, chills, joint pain, and fever. Although adverse events classified as mild to moderate and severe are not common, the nation’s top regulatory agency still recommends that people with a “historical history of major allergic reactions” still avoid the new Pfizer Biotechnology vaccine.
Additionally, the study data monitoring committee did not report serious vaccine-related safety issues. Efficiency is consistent across people of different ages, genders, races, and nationalities. All trial participants will continue to monitor for two years after the second injection to assess long-term protection and safety.
Dr. Nancy Messonnier of the US Centers for Disease Control and Prevention said at the meeting that she would continue to pay attention to any adverse reactions to Pfizer vaccines by vaccinated medical personnel and facility residents. long-term care. They will use a text messaging system called v-safe, designed to understand the first signs of potential adverse effects from the vaccine.
Furthermore, the members of the VRBPAC committee also discussed a very interesting matter, whether to stop blinding and vaccinating the placebo group with the real vaccine.“This is also a classic medical paradox: Giving the placebo group a vaccine that is currently considered effective, or continuing to look at a vaccine that seeks long-term safety and effectiveness, neither is ethically wrong. The US FDA Finally I chose the last option, I refused to stop blinding and I got vaccinated after at least six months of safety data, ”the aforementioned public health professional told the Caijing reporter.
Emergency use authorization is different from full approval, which usually takes several months.
The US FDA continues to evaluate safety data for Pfizer vaccines, so the vaccines entering the market can only be used in a limited number of specific populations, such as hospitalized patients.
Pfizer has only submitted two months of follow-up safety data. However, in the aforementioned Pfizer announcement, it plans to obtain full approval through a known biologics license application before April 2021.
“Previously, vaccines using mRNA technology have not been successful. If this vaccine can be approved for commercialization and applied without problems, it will eventually be safe and effective, and it will be a major advance in the application of human vaccine technology.” Yu Wenzhou said. .
Select the new corona vaccine that young people can use
A US FDA document noted that the Pfizer vaccine does not have enough data to draw conclusions about the safety of children under 16 years of age, pregnant women, and people with compromised immune systems. More safety data on the vaccine are still needed.
Pfizer admitted at its December 10 meeting that it lacked information on the impact of the vaccine on pregnant women. Pfizer spokeswoman Jerica Pitts said in a statement: “We recognize that the development of a widely available covid-19 vaccine, including potential use in pregnant women, is essential to curb the new coronary pneumonia disease.”
The company representative said it is conducting a DART study and plans to obtain preliminary results in mid-December and submit the available data to the US FDA. The purpose of the DART study is to assess the potential risk of vaccines for development. fetal.
In addition, the company lacks information on the impact of the vaccine on adolescents under 16 years of age.
Before the vote at the aforementioned US FDA meeting, some experts who participated in the meeting believed that emergency use authorization should be limited to individuals over 18 years of age, and believed that the safety data in 16 and 17 year olds were very weak.
“I want to join the lineup that supports this point of view. I think this data is very weak and not enough to show that we are safe in the case of low incidence.” Mark Sawyer, expert panel voter and infectious disease expert at the University of California San Diego School of Medicine, said the doctor at the meeting.
Many panelists are asking the FDA and Pfizer to keep this topic under review.
On the same day that the Pfizer vaccine was licensed for emergency use, Moderna, another mRNA vaccine research and development company, began a study in young people to select candidate covid-19 vaccines for use in adolescents.
The company will recruit 3,000 US participants to evaluate the safety and efficacy of the COVID-19 vaccine for adolescents ages 12 to 18.
Stéphane Bancel, CEO of Modena, said: “Our goal is to generate data in the spring of 2021 and support the use of mRNA-1273 in adolescents by the 2021 school year.”
The US FDA is expected to decide later in December whether to approve the vaccine developed by Modena for mass use.
According to the US government’s description of “Speed Warp Operation”, 2.9 million doses of vaccine will be loaded onto trucks within 24 hours and then delivered to 636 distribution points in the United States. First, hospitals, then national facilities and drug distribution centers, and finally medical clinics and pharmacies.
The herd immunity barrier will not be established anytime soon, but in any case, “three new corona vaccines have been approved for emergency use in the world so far, and the epidemic will gradually be brought under control as the number of vaccinations increases.” Yu Wenzhou said.
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