Please note this message was distributed by Kelsey Research Foundation on December 10, which was prior to the FDA’s approval of the COVID-19 vaccine on December 11.
On the eve of what likely will be a historic meeting of the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC), I am pleased to share with you, on behalf of the Kelsey Research Foundation, my knowledge and expertise on the COVID-19 vaccine development.
I started my career in infectious diseases investigating epidemics at the Centers for Disease Control and Prevention. For the past 30 years, I have served on the advisory board or as a consultant to the FDA Center for Biologics Evaluation and Research, which oversees the approval of vaccines in the United States; have been on the team to select influenza viruses to include in annual immunizations practices; and have remained involved with the CDC during the current COVID pandemic, which has resulted in death rates not seen in more than 100 years.
The speed with which the scientific community is developing vaccines is commendable and the result of years of research. Normally, it takes 10 years for a vaccine to reach licensure after initial development due to safety testing and clinical trials to establish effectiveness. Moderna Therapeutics was the first to begin vaccine trials in mid-March 2020, and it likely will be approved and ready for widespread use later this month, less than 10 months from study initiation. Pfizer, Inc., in partnership with BioNTech Manufacturing GmbH, began its efficacy trials in mid-July 2020 and is anticipated to receive Emergency Use Authorization this week from VRBPAC. The speed of this vaccine program relates to our government’s Operation Warp Speed and demonstrates the importance of investing in scientific research.
What is mRNA Vaccine?
The vaccines we know today, such as the flu vaccine, are antiviral vaccines that use inactivated (killed) or live weakened (attenuated) viruses or are given as a component (subunit antigen) of the disease- causing pathogens. Recently, infectious diseases research has become more molecular, resulting in the development of DNA and messenger RNA (mRNA) vaccines, which offer greater disease prevention capability than classical vaccines. In the case of mRNA vaccines, a small piece of genetic code is placed inside a tiny fat bubble called a lipid nanoparticle and is injected into our muscle. The genetic code directs the body to produce the coronavirus spike protein (the part that allows the virus to produce disease) and tricks the body into thinking the vaccine-induced protein is in fact the virus attacking the body.
mRNA vaccines (Pfizer/BioNTech and Moderna/NIH) have advantages because of high potency allowing rapid development, low manufacturing cost, and safety. In trials conducted and reported to date, the vaccines given to more than 70,000 people have prevented 90-95% of the infections that would have occurred without the vaccine. This provides evidence these are among the most effective vaccines we have ever seen, much more effective than flu vaccines.
A benefit to mRNA vaccines is that although COVID-19 can mutate, the vaccine will be directed to part of the cell that produces disease (the spike protein) making the need to have frequent annual adjustments (similar to the flu vaccine) unnecessary.
Is a mRNA Vaccine Safe?
- mRNA vaccines do not contain a live virus and do not carry a risk of causing disease in the vaccinated person.
- The mRNA particle does not enter cell nuclei and does not affect or interact with a person’s DNA.
- mRNA vaccines are being held to the same rigorous safety and effectiveness standards as all other types of vaccines in the United States. The only COVID-19 vaccines the FDA will make available for use in the United States (by approval or emergency use authorization) are those that meet these standards.
The vaccines will be given in two (2) doses three to four weeks apart. mRNA vaccines work by producing inflammation, so 2-9% of people receiving vaccine could have a sore arm, muscle pain possibly with local redness, day-long fatigue or headache. These are short lasting symptoms.
What This Means for Houstonians
There is reason to believe, and I agree with this conclusion, that the pandemic will be controlled in 2021.
We all have been affected by this virus from disease and losing loved ones, economic losses, tremendous inconvenience, or a combination of all. We need to participate in the removal of the disease-producing virus through vaccinations and current safety measures since the public is where it lives and how it spreads.
Masks and social distancing must be maintained until research has shown sufficient levels of herd immunity, approaching 90% of the population, probably occurring by the fall of 2021 if we all work together.
A potential post-COVID benefit of mRNA vaccine technology is that it could lead to emergence of effective anticancer vaccine revving up the body’s immune system against cancer cells taken from affected patients as part of a potentially powerful program of personalized medicine.
Additional information about the vaccine can be found at: CDC's COVID-19 mRNA vaccine webpage.