Pfizer announces results in vaccine testing process
Pfizer and BioNTech announced Monday their vaccine candidate was over 90% effective against COVID-19 in Phase 3 trials.
Pfizer is an American pharmaceutical corporation and BioNTech is a German biotechnology company. They began the first phase of testing on Apr. 22 and are now in the final phase.
In Phase 3, the vaccine candidate was given to 43,538 participants. Half were given the candidate and half were given a placebo of salt water. There are 94 confirmed cases of COVID-19 out of all of the participants. Based on how many of these 94 were given the vaccine candidate versus the placebo, the candidate was found to be 90% effective.
The vaccine consists of two doses given 21 days apart. Participants were immune seven days after the second dose was given.
Approximately 42% of global participants have racially and ethnically diverse backgrounds. In late October, the study was expanded to include minors as young as 12.
Phase 3 is expected to continue until a total of 164 COVID-19 cases have accumulated. Pfizer chairman and CEO Dr. Albert Bourla stated that the company should have enough data to submit a request for approval to the FDA by the third week of November.
The independent Data Monitoring Committee that analyzed the Phase 3 study has not reported any serious safety concerns or side effects.
Pfizer and BioNTech’s vaccine candidate will be submitted for Emergency Use Authorization (EUA). EUA allows the FDA to make a product available to the public without as much data as would normally need to be provided in the regular approval process.
Vaccine development often takes 10 years in order to determine all possible side effects and longevity of the vaccine. In this case, longevity will be an afterthought due to the widespread impact of COVID-19. The FDA will continue to monitor approved vaccines for a couple years to be sure of public safety.
Pfizer stated they are expected to produce 50 million doses of the vaccine in 2020 and 1.3 billion in 2021. These doses would most likely go to health care professionals and high-risk people, specifically the elderly.
Operation Warp Speed is a program started by the Trump Administration with the goal to produce and deliver a vaccine by January 2021. The program has provided funding for development, manufacturing and distribution of the Pfizer/BioNTeach vaccine as well as many others.
The program recently made a deal with CVS and Walgreens. The pharmacists will assist in the distribution of the vaccine at nursing homes, which will be the first to receive the vaccine. Nursing homes need to sign up for the program in order to receive CVS and Walgreens’ assistance.
The vaccine would not be transported by military vehicles but instead by private companies such as FedEx.
Senior vice president of CVS Health Chris Cox says all CVS pharmacies are equipped to store the vaccine and they will be prepared to offer vaccines to the general public in the first couple months of 2021.
Studies have shown that older people have less of an immune response to vaccines. The Pfizer/BioNTech trials included people over 65, so they will eventually provide the success of the vaccine on these participants.
COVID-19 cases are reaching an all-time high, both in the United States and worldwide. When cases are higher, it is easier to tell if the vaccine is effective.
The U.S. will provide nearly $2 billion to assist Pfizer and BioNTech in production and distribution. The government also supports five other vaccine trials by different companies.
Moderna, AstraZeneca/Oxford University and Johnson & Johnson all have more recently begun Phase 3, but have not reported any results yet.
After this news was announced Monday, the stock market got a lot of activity. BioNTech’s shares shot up 23.4% and Pfizer’s shares were up 11.5%. Shares in companies that have been hurt due to the pandemic soared, while Zoom, Netflix and Peloton’s shares dipped. This activity gave many hopes that the economy can return to normal.
Dr. Fauci as well as many other medical experts and government officials stress that this good news does not mean that the public can stop wearing masks, washing hands and practicing social distancing.