The US FDA has released a 53-page report regarding Pfizer and BioNTech candidate vaccine trials. It has supported the earlier findings that the vaccine is 95% effective and safe for public use. The companies have applied for emergency use authorization with the FDA in the age group of 16 and above. Even though the vaccine is still being tested in the 12-15 age group, there is not enough data to request authorization.
FDA Releases 53-page Report Summarizing Data From Pfizer Vaccine Trial
The FDA panel that is in charge of reviewing the vaccine is set to meet on Thursday and authorization can be given on the same day if everything goes as per the expectations of the company. Another vaccine candidate by Moderna is set to be reviewed next week.
Experts who have so far seen the clinical trials data have said that there are no significant areas of concern with regards to the candidate vaccines. The efficacy of the product appeared good, and there were no surprise findings so far.
The report provides insights into how some groups of people fared with regards to BNT162b2 vaccine candidates that included people over 65 and others with pre-existing medical conditions like diabetes. The vaccine worked well on all the groups, and there were no major areas of concern.
The average age of the participants was 51, and nearly one-third of the participants met the definition of obesity in the group. The recipients appeared better protected than others, and this puts to rest all the concerns with regards to the vaccine not being effective in older people and those with pre-existing health conditions.
The vaccines are given in two doses, and the first dose seemed to offer 52% protection. The second dose would be given after a gap of three weeks from the first. As of now, there is no evidence of the protection lasting longer than a few weeks. However, a second or booster dose usually extends the protection of the vaccine in other cases.
Some participants experienced mild side effects after receiving the second dose, and the effects lasted for a day or two. The most common side effect was a sore arm, and it was seen more in participants under age 55. Other side effects included fatigue that was experienced by about 60% of the trial participants, especially after the second shot.
Apart from that, close to 52% of the participants reported a headache after receiving the second shot while close to one-third of the participants complained about muscle aches and chills after taking the vaccine. About 45% of people took pain medication after taking the second shot, and only 25% took pain medication after taking the first shot.
The FDA reports that summarized the clinical trials data said that the vaccine met the expectations of the agency. The vaccine manufacturer will continue to monitor the trial participants and conduct new tests to follow people who receive the vaccine after approval by the FDA. This will help them to get better insights about the performance of the vaccine.
Experts feel that when the vaccine is used for mass vaccination programs, some other health complications that are otherwise rare may crop in future. However, this is natural as the clinical trials are done only on 22000 people so far, and the final effect will be known only after millions of people are vaccinated across the country.
Even though the FDA is expected to authorize the vaccine, it may not provide full approval as there is no clarity on how long the protection would last after taking the vaccine. In this crisis situation, the agency is first looking at a vaccine that is safe to use, and the next concern is the effectiveness. In a normal situation, it would take about two years to get a full approval.
The vaccine manufacturers are expected to follow trial participants for the next two years and submit a full application depending on the data they get from the complete trials. This is good news for the health care workers as they are likely to get some protection during the pandemic. The rising number of cases and increased hospitalizations in recent weeks has put a burden on the public health care system and the arrival of vaccines in the next few weeks can reduce the cases by some margin.
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