Health
Infectious disease experts discuss vaccines
Crystal Run Healthcare infectious disease specialists closely track the development of the coronavirus pandemic and COVID-19 vaccine. Oladipo A, a board-certified infectious disease specialist. Alao, MD, MPH and FACP want patients to know about the COVID-19 vaccine, from development and timeline to different types and possible side effects.
COVID-19 Vaccine-What We Know
In December 2019, the first case of becoming known to the world as coronavirus or COVID-19 occurred in Wuhan, China. The virus shared similarities with “SARS,” a respiratory disease that prevailed in China from 2002 to 2004. Scientists began developing vaccines and testing them in Phase 1 trials before they knew how terrible the outbreak of “SARS” would be. Vaccine development stalled when the outbreak no longer seemed like a threat. But what was done more than 10 years ago was not in vain. This work provided a platform for accelerating the timeline for the development of the COVID-19 vaccine, reducing the time required to work and design exploratory vaccines.
Vaccine development
To develop a vaccine, you need to understand how the virus attacks cells. Both the coronavirus “SARS” and COVID-19 use spike proteins to attach to cells. Peplomers promote receptor binding and membrane fusion to angiotensin converting enzyme 2, an enzyme that regulates blood pressure on host cells. The study targets peplomers and their receptor-binding domains for vaccine development. Vaccines that produce antibodies against peplomer targets have been shown to neutralize the coronavirus and form a defense first in non-human primates and then in humans.
I’ve heard a lot about the development timeline. Yes, it’s easy to hear “Operation Warp Speed” and wonder about the process, but the vaccine was developed faster than usual. Acceleration of the vaccine timeline does not mean that any stage of clinical trials has been skipped. Companies have carefully planned development to save time if things go well, and previous research and early results were promising, allowing companies to duplicate the following steps:
: • Phase III clinical trials were initiated after the initial analysis of Phase I / Phase II trials.
• Commercial production began before the final results of Phase III trials.
• Reviews have been sped up.
• The vaccine has been approved by an Emergency Use Authorization (EUA).
The initial information from each was so promising that the company was able to duplicate these steps. They ensured that all proper steps were performed in a short amount of time.
What is the type of COVID-19 vaccine?
Researchers have used many methods to develop the COVID-19 vaccine. They include traditional vaccine pathways such as live attenuated viral vaccines, use of inactivated viral vaccines, and recombinant protein vaccines, non-replicating vector vaccines, replicative vector vaccines, inactivated viral vector vaccines, DNA, etc. I’ve been using a recently developed route. And RNA (ribonucleic acid) vaccine.
RNA vaccines have been developed relatively recently and are either mRNA or self-replicating RNA. mRNA provides the genetic information for an antigen so that cells in the body can make it. To combat COVID-19, mRNA is delivered by lipid nanoparticles (LNPs) to ensure that it reaches its destination. mRNA is then degraded shortly thereafter and does not affect human DNA. The antigens produced by the cells then produce an immune response that neutralizes the virus.
The advantage of RNA vaccines is that the process does not involve dealing with the actual virus. However, RNA vaccine technology is still improving. Large-scale production and storage of these RNA vaccines poses unique challenges for distribution.
The first two COVID-19 vaccines approved in the United States. Both PfizerBNT162b2 and Modern RNA-1273 are mRNA vaccines that have undergone all three stages of non-human primate research and human clinical trials before the FDA issued an emergency use authorization. Participants were monitored for at least 60 days after the second dose to allow sufficient time to observe if side effects occur. Historically, vaccine effects have tended to occur within that 60-day time frame. The timelines for these vaccines have been accelerated, but not shortened. This should reduce hesitation over safety concerns.
What are the side effects?
The Phase 1 trial of the modelna vaccine began in March 2020, with 45 participants enrolled and 15 receiving 3 different doses each. The interim analysis after the 57th day has been released. The Phase 1 trials of both Pfizer BNT162b1 and BNT162b2 enrolled 195 participants in 13 groups, with each group receiving different doses of each vaccine for each age category 18-55 and 65 years and older. Included 12 individuals who received the dose. The most common side effect of both vaccines was pain at the injection site. To view more detailed reports on side effects and to find out more about vaccines, please visit the CDC website: https: //www.cdc.gov/coronavirus/2019-ncov/vaccines/expect
A 100 µg Moderna vaccine was tested in a Phase III study in July 2020, enrolling 30,420 people over the age of 18 who received either the vaccine or placebo. Results were published 60 days after the second dose, showing a vaccine efficacy of 94.1 percent. The data showed that 196 registrants, 185 who received placebo, and 11 who received the vaccine developed COVID-19. The 30 µg Pfizer BNT162b2 was subsequently subjected to a phase III trial in 43,448 patients, 170 developing COVID-19, and only eight recipients in the vaccine group. The results of the Phase III trial were recently published and pain at the injection site was once again the most common side effect. Since the availability of these vaccines, approximately 30 cases of severe allergic reactions to the Pfizer and Moderna vaccines have been reported (last updated January 15). These outbreaks remain relatively rare, given that more than 27 million doses have already been given. Vaccine distribution sites have measures taken to observe individuals after administration. Long-term safety data for these vaccines are not yet known, but vaccine recipients are being monitored and more information will continue to be gathered.
There are other vaccines that have been developed using the various vaccine processes highlighted above, and they should be available soon. The COVID-19 vaccine has been very effective so far and may remain effective against reported strains of the virus, but may not induce “bactericidal” immunity. If this is very unlikely. This is why social distance measures and masks are still needed to control the spread of the virus.
Help fight COVID-19 and get vaccinated
With so many viruses still prevalent in our community and around the world, we need as much help as we can to combat this pandemic. Vaccination is another precaution that can help protect you from COVID-19. Combined with wearing a mask, increasing social distance and avoiding congestion, the risk of getting a virus and becoming seriously ill can be significantly reduced. Crystal Run Healthcare recommends vaccination to prevent the spread of COVID-19. If you have any questions about your vaccine, talk to your provider. Together, we can end this pandemic.
Oladipo A. Alao MD, MPH, FACP are fellowship-trained infectious disease specialists with a medical degree from the Ibadan Medical College in Ibadan, Nigeria. Dr. Arao is a board accredited in infectious disease and internal medicine and has a clinical interest in HIV and travel medicine. He provides care to patients in West Nyack and Monroe.
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