Moderna and Pfizer COVID-19 vaccine trials show that side effects are common in participants and it appears that the more significant symptoms develop following the second dose.
The Pfizer-BioNTech’s mRNA coronavirus vaccine (BNT162b2) is both safe and effective, according to the U.S. Food and Drug Administration (FDA). FDA said results from Pfizer’s large, ongoing study showed the vaccine, which was co-developed with Germany’s BioNTech, demonstrated more than 95% efficacy across people of different ages, races and underlying health conditions, including diabetes and obesity. And partial protection from coronavirus appears to begin 12 days after the first dose, according to Pfizer. Consequently, Pfizer requested and the vaccines are expected to be approved for emergency use authorization (EUA) by the FDA as early as this week.
And this week, a committee of leading U.S. vaccine scientists recommended that the Food and Drug Administration authorize the first COVID-19 vaccine for Americans.
FDA approval of a drug means that the agency will have determined, based on substantial evidence, that the drug is effective for its intended use, and that the benefits of the drug outweigh its risks when used according to the product’s approved labeling. Approval of the he vaccine will help reduce the risk of disease. The vaccine works with the body’s natural defenses to safely develop protection (immunity) to disease, according to the FDA’s website.
How an mRNA vaccine works
Messenger RNA vaccines, called mRNA for short, is a new kind of vaccine technology that has never before been licensed in the U.S. mRNA vaccines contain material from the virus that causes COVID-19 that gives our cells instructions for how to make a harmless protein that is unique to the virus. The objective of a vaccine is to teach your immune systems how to recognize and fight the virus that causes COVID-19, according to the Centers for Disease Control and Prevention.
Messenger RNA vaccines aren’t like past seasonal influenza vaccines. An mRNA vaccine is essentially just a piece of genetic code that contains instructions for our body. The mRNA tells our cells to make a protein — the same protein that is the spike on top of the actual coronavirus. This is what triggers the immune response in these types of vaccines.
Innovative technologies like mRNA vaccines, currently being investigated, may be critical in the fight against #COVID19 — watch to learn more. pic.twitter.com/FN5rW34ULR
— Pfizer Inc. (@pfizer) December 8, 2020
In contrast, past seasonal influenza vaccine puts a weakened or inactivated virus into your body to trigger an immune response, which then produces antibodies. Those antibodies are what ultimately protects you from getting infected if you ever encounter the real virus.
It typically takes a few weeks for the body to build immunity against COVID-19 infection after vaccination. And after vaccination, the process of building immunity can cause symptoms or “side effects”. These symptoms are normal and are a sign that the body is building immunity.
As independent experts review an EUA request for a #COVID19 vaccine tomorrow, you may want to know how COVID-19 vaccines have been developed so quickly. Here’s FDA Commissioner @SteveFDA with some insight. #AskDrHahn #FDAVaccineFacts pic.twitter.com/u3nmeF8rRW
— U.S. FDA (@US_FDA) December 9, 2020
Side effects
Sometimes the vaccine process of teaching your immune system how to react to the virus can cause symptoms. These symptoms are normal and are a sign that the body is building immunity. Moreover, no major safety issues were uncovered and common vaccine-related side effects like fever, fatigue and injection site pain were tolerable, according to the FDA.
The most common vaccine side effects were injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), and fever (14.2%), acc riding to the report submitted to the FDA.
Severe adverse reactions occurred in 0.0% to 4.6% of participants and appeared were more frequent after the second dose than after the first. The frequency of serious adverse events was low (<0.5%), without meaningful imbalances between study arms.
Although some COVID-19 trial participants reported COVID-like symptoms, it is impossible to contract the coronavirus from the vaccine, because the mRNA vaccines develop by Pfizer and Moderna don’t use the live virus.
Bottomline
Getting vaccinated is one of many steps you can take to protect yourself and others from COVID-19. Vaccines work with your immune system so your body will be ready to fight the virus if you are exposed.
References:
- https://www.cnbc.com/2020/12/08/pfizer-moderna-covid-vaccine-side-effects-trials.html?__source=iosappshare%7Ccom.microsoft.msedge.EMMXShareExtension
- https://www.fda.gov/media/144245/download
- https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/how-they-work.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fvaccines%2Fabout-vaccines%2Fhow-they-work.html
- https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits/facts.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fvaccines%2Fabout-vaccines%2Fvaccine-myths.html