- Oxford University and AstraZeneca announced the results of a vaccine trial on Monday.
- On November 20, Pfizer and BioNTech announced the submission of an emergency use authorization application to the FDA.
- The FDA said that the agency has been preparing for the review of the new coronavirus vaccine for several months.
British Health Secretary Matt Hancock said that the United Kingdom plans to launch two new coronavirus vaccines next month. Then, the advancement of the vaccine plan will speed up after entering the new year. From there, the situation will gradually return to “normal” from the spring.
Oxford University and AstraZeneca announced the results of a vaccine trial on Monday, showing that their co-developed new coronavirus vaccine can prevent most people from contracting the virus.
Hancock made this statement after the test results were announced. Prior to that, Pfizer also announced the positive test results of the vaccine it developed earlier this month.
Hancock said in an interview:
“It’s really encouraging news . . . nobody who took it ended up in hospital or had serious conditions. We hope to be able to start vaccinating next month. The bulk of the vaccine roll out programme will be in January, February, March. And we hope that sometime after Easter things will be able to start to get back to normal.”
He added, “we are looking with high confidence now that after Easter things can really start to get back to normal.”
Following a new wave of cases that forced the British government to re-impose the lockdown order this month, the release of the latest vaccine test data has added to its optimistic confidence that the situation will begin to reverse.
Hancock said that the number of new cases “has clearly started to decline,” and the cabinet ministers are discussing how to relax various restrictions so that families can be reunited at Christmas. Prime Minister Boris Johnson will announce a new winter strategy in Parliament on Monday.
“The increase in new cases is flattening off, but we are not out of the woods yet,” Johnson will tell lawmakers, according to his office. “With the expansion in testing and vaccines edging closer to deployment, the regional tiered system will help get the virus back under control and keep it there.”
Pfizer Vaccine Approval will Become the Focus of the Market
On November 20, Pfizer and BioNTech announced the submission of an emergency use authorization application to the FDA. The two companies expect their jointly-developed vaccine may be used in high-risk populations in the United States between mid-December and the end of December 2020. However, to obtain the final authorization, the FDA’s external advisory meeting on December 20 is very important.
The FDA announced on its official website on November 20 that it has scheduled a vaccine and related biological product advisory committee meeting (VRBPAC) on December 20 to discuss the emergency use authorization (EUA) application for Pfizer and BioNTech’s new coronavirus vaccine.
The FDA said that the agency has been preparing for the review of the new coronavirus vaccine for several months, and the review committee will be composed of external experts. What needs special attention is that there are two key points during this review meeting.
The first time point is two days before the meeting. The FDA stated that it plans to release the background materials, meeting agenda, and committee list to the public no later than two working days before the meeting.
Bloomberg believes that the FDA usually releases its staff reports on clinical trial data at this time, which will help understand whether the FDA is inclined to approve the vaccine.
The second point in time is at the end of the meeting, when a non-binding vote will be held to decide whether to use the vaccine for public purposes.
Bloomberg said that FDA staff will sort out Pfizer’s raw data that is not available to the public, rather than relying on Pfizer’s own results to determine the effectiveness and safety of the vaccine. In addition, the FDA and Pfizer will separately summarize their findings to the advisory group.
On the 9th of this month, Pfizer and BioNTech were the first to announce that their mid-term clinical analysis showed that the effectiveness of the new coronavirus vaccine reached 90%.
On November 18, Pfizer and BioNTech announced the final analysis of the Phase III clinical trial of their new coronavirus vaccine. The effectiveness was 95% and there were no serious adverse reactions.