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Editor |Xu Yue
Although the U.S. Food and Drug Administration (FDA) has held advisory committee hearings on hundreds of products over the past year, none have garnered such significant attention.
At 10:00 p.m. on December 10 (Beijing Time), the U.S. Food and Drug Administration (FDA) will hold a public meeting of the Vaccines and Related Biological Products Advisory Committee, where clinicians, vaccine experts, and statisticians will jointly discuss the Emergency Use Authorization application for the COVID-19 vaccine submitted by Pfizer and BioNTech. Emergency authorization can expedite the approval process, which would otherwise take several months, but it inherently involves a balance between risks and benefits.
According to The Wall Street Journal, Kathrin Jansen, head of vaccine research and development at Pfizer, and William Gruber, senior vice president of vaccine research, are expected to discuss severe cases and any safety issues at tonight’s meeting.
Prior to the meeting, U.S. President Trump had already called for early emergency authorization of the vaccine, following the United Kingdom’s approval of emergency use for the COVID-19 vaccine on December 2.
According to the briefing for this hearing released in advance by the FDA on its official website on December 8, the immune response to the vaccine began to take effect rapidly after the first dose, with an efficacy rate of approximately 88% within one week. After the second dose, the efficacy rate increased to over 95%, enabling more durable immunity.
FDA Scientists Find That the First Dose of the Pfizer/BioNTech COVID-19 Vaccine Effectively Reduces the Risk of Confirmed Severe COVID-19 in Recipients. This Is Considered a Significant Discovery, as Some Experts Previously Believed That COVID-19 Vaccines Could Only Prevent the Risk of Mild to Moderate Illness.
Adverse reactions to this vaccine are more common in younger populations, with the most frequent complaints being fatigue, myalgia, and arthralgia. Severe adverse reactions are rare, occur more frequently after the second dose, and are less common in individuals aged 55 years and older.
A virology expert at Georgetown University stated in the aforementioned interview that adverse reactions occurring shortly after injection indicate that the vaccine is eliciting a robust immune response. “This does not mean that the vaccine will weaken the recipient. However, recipients should be aware that they may feel unwell for one to two days following vaccination.”
The briefing document also noted one case of severe infection in the vaccine group and three cases in the placebo group. Six deaths occurred during the trial, with four in the placebo group and two in the injection group.
However, it should be noted that these deaths were all unrelated to the vaccine.
Among the deaths in the injection group, an elderly volunteer with arteriosclerosis died three days after the first injection; another elderly volunteer experienced cardiac arrest 60 days after the second injection and subsequently died.
When Johnson & Johnson’s COVID-19 vaccine trial was previously paused due to a participant developing an unexplained illness, STAT, a pharmaceutical industry media outlet, interviewed informed sources who stated that given the scale of COVID-19 vaccine clinical trials, it is not surprising for various situations to arise during research. “If we study 60,000 people, all kinds of medical events will emerge one after another.”
Pfizer’s Phase II/III clinical trial for this vaccine was a multinational study enrolling 44,000 participants. Among the 37,600 individuals for whom safety data have already been analyzed, there were 8,204 adults aged 65 years or older, 13,000 obese individuals, 13,000 overweight individuals, 7,623 participants with comorbidities such as diabetes, and 9,208 participants with hypertension. The clinical trial requires a two-year observation period.
In this large-scale clinical trial, adverse events occurring in all groups will also be analyzed in detail.