As people in the US start getting the COVID-19 vaccination, indica News had the pleasure of interviewing Dr. Prasun J. Mishra.
Dr. Mishra (Ex-Genentech, Ex-NCI, Ex-NIH) is the founding president and CEO of the American Association for Precision Medicine (AAPM) and chair of ACT: AAPM Coronavirus Taskforce, leading research efforts focused on preventing and curing COVID-19, cancer, and other chronic diseases; not only treating the sick but also providing knowledge/tools for individuals to live longer, healthier lives.
Widely recognized as a Technology and Healthcare thought leader, Dr. Mishra has keynoted, chaired, and organized numerous successful international conferences. His research work has been recognized globally by over 40 prestigious awards and honors. Dr. Mishra also served as a Scientist and Principal Investigator at Genentech, Roche. Moreover, his passion for drug development and precision medicine has led to the identification of new drug targets, biomarkers, companion diagnostics, and several drugs/ combinations in the clinic. Due to his unique perspective and selfless service, he is highly respected and sought-after mentor to many.
Please, share your reactions to the final announcement of the COVID-19 vaccine by Pfizer? Are you pleased or concerned?
I am very pleased as this is one of the greatest achievements for the scientific community. Bringing an mRNA vaccine candidate from discovery to patients, in less than a year, is unheard of and is truly remarkable.
What is the name of the vaccine? And where is it now approved and available?
The vaccine is widely called the Pfizer-BioNTech COVID-19 vaccine. The code name used in clinical trials is BNT162b2. About 95% of people 16 years and older who got the two doses of the vaccine, 21 days apart, were protected from becoming seriously ill with COVID-19 (https://bit.ly/3rbLKpV).
On December 8th, a UK grandmother was the person in the world to be given the Pfizer vaccine as part of that country’s mass vaccination program. And on December 14 a nurse, Sandra Lindsay at the Long Island Jewish Medical Center, NY. was the first person in the U.S. to receive the vaccine.
Is there any other COVID-19 cure vaccine that got approved by FDA under Emergency Use Authorization (EUA) request?
To date, only the Pfizer vaccine has received emergency use authorization (EUA) in the US. However, there is Moderna vaccine, which has an efficacy rate of 94.1%, is under review for Emergency use authorization with US FDA. If all goes well, Moderna’s vaccine could receive EUA from the US FDA by the end of this week and can be administered to public by next week (https://wapo.st/2WpwN52)
I read there are three phases of this trail, please brief. Has Pfizer gone through all the trail phases or is the trial ongoing?
The Phase 3 clinical trial of BNT162b2 is ongoing. The trial began on July 27, and as of November 13, 2020, 41,135 people have received a second dose of the vaccine. Pfizer performed an interim analysis with 170 cases in the ongoing Phase 3 trial participants and found that 162 of the infections occurred in people who received placebo. Eight of the cases were in volunteers who had been given the vaccine, giving it a 95% efficacy rate (https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine).
What’s your concern — the report says not yet for age 15 and younger? How will they go to school?
Pfizer vaccine is only authorized in patients 16 and older. Pfizer has plans to change this in the future; however, for now, the safety and efficacy of the vaccine in the ages 15 and below remain unclear. Moreover, to date over 300,000 deaths have occurred due to COVID-19 in the US so I think we have to take one step at a time. I think remote learning is the best option until we establish that vaccination is effective in preventing the spread of COVID-19.
What are the possible side effects? Who should avoid the vaccine?
The Pfizer vaccine is an mRNA vaccine and it does not contain a live virus. The side effects of the vaccine include muscle aches, fever, fatigue, headache, chills, and joint pain. Most of the side effects surface in the first few days upon receiving the vaccine, lasting for about three days. People are advised to contact their r physician if they have a reaction lasting beyond three days.
There are three groups who should avoid the vaccine for now:
- Children under the age of 16 as there is no data on how the vaccine will affect them.
- Pregnant women, as there is no data on how the vaccine will affect their unborn child.
- People with a history of a strong allergic reaction might have a risk of developing an anaphylactoid reaction.
Do you fear there will not be enough supply to meet the demand?
I don’t think supply matches the demand to vaccinate everyone in the world. However, based on current projections, Pfizer is expected to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021. Other vaccines will become available in the future to address global vaccination needs.
Will the vaccine provide a sustained immunity against COVID-19? Should we stop taking precautions after getting vaccinated?
After receiving the vaccine, it takes some time for the immunity to build. During that time there is still a chance of getting infected with the virus. The Pfizer vaccine EUA approval is based on the safety and efficacy data on two months of follow-up after BNT162b2. Usually, six months of follow-up is required for the full FDA approval. So, in my opinion, we are still learning more about how long the immunity lasts after the COVID-19 vaccination. We will also learn if vaccinations are effective in preventing the spread of SARS-Cov-2.
What concerns me is COVID-19 is known to deplete important immune cells thereby weakening our immune system (https://nyti.ms/34jNGTg). There are several reports of people getting reinfected with COVID-19 after they have recovered from an earlier COVID-19 infection, indicating that that immunity against COVID-19 may be fragile and wane relatively quickly. These reinfections are a threat not only for recovered patients but also for folks who got vaccines (https://bit.ly/37pXQ6H).
So, until we establish that vaccination confers herd immunity and stops the spread of COVID-19, I would recommend following the precautions suggested by CDC to avoid COVID-19 infection. These include avoiding close contact, wearing cloth face coverings in public places, practicing good hygiene, and staying home if you’re sick. Thank you.