Since December 2020, the FDA has given emergency use authorization (EUA) to three COVID-19 vaccines. The vaccine developed by Pfizer-BioNTech recently received full approval by the FDA for use in people 16 and older. We want to make sure the 85 million eligible Americans who are still hesitant about the vaccine have the right information and understand the importance of getting it.
The FDA approval is the result of extensive data on safety and efficacy that meets a certain set of requirements. The authorizations, including the use of the Pfizer-BioNTTech vaccine in ages 12-15 and the Moderna and Johnson & Johnson vaccine in people 18 and older, are based on extensive data that have established that the benefit of these vaccines outweighs any known or potential risks. Being vaccinated also helps reduce the risk of more variants, like Delta, emerging.
Our Pharma domain expert Amichai Perlman helps us debunk common myths about the vaccine.
Myth: We don’t know the long term effects of the vaccine.
Fact: The vaccine is only present in the body for 1-2 months, and this is when it exerts its effects.
The vaccines have all been used by hundreds of millions in the US and abroad with extensive monitoring. Large clinical trials, with tens of thousands of participants carefully followed for at least two months following the last vaccine dose, have shown good safety, and that severe side effects are rare. All known vaccine side effects (for all vaccines) occur shortly after vaccination and up to 6 weeks following vaccination.
The vaccines have been proven to reduce the risk of COVID-19—a disease more likely to cause severe complications as well as long term illness.
While additional rare side effects may be discovered as more people get vaccinated, there is no basis for side effects occurring long after the vaccine has been given.
Myth: The vaccine can affect fertility.
Fact: COVID-19 vaccines have been given to hundreds of millions of people in the US and around the world with no sign of impact on fertility.
According to the CDC, the COVID-19 vaccination is recommended for everyone 12 years of age and older, including people who are trying to get pregnant now or might become pregnant in the future, as well as their partners. Research (and real life) shows COVID can cause serious illness in pregnant people, so it’s important to get that vaccine, whether you are trying to get pregnant or already pregnant.
Myth: If I’ve already had COVID-19, I don’t need a vaccine.
Fact: Early evidence shows that natural immunity may not last very long, and that the vaccine offers additional protection, especially as new variants emerge.
Early evidence shows that natural immunity may not last very long, and that the vaccine offers additional protection for coronavirus than just having the virus. Several people in the Pfizer vaccine trial had COVID before getting the vaccinate and had minimal side effects.
With the new variants emerging, and re-infection possible, the vaccine is still advised for people who’ve had COVID-19.
Myth: Vaccinated people are still getting COVID19, so what’s the point?
Fact: The approved coronavirus vaccines consistently show a significant reduction in the risk of COVID-19 cases, hospitalizations, and death.
All vaccines, including these, do not prevent 100% of illnesses. This is also true about immunity if you’ve had the virus.
As more variants emerge, re-infection becomes higher. The Delta variant is more contagious than previous variants, and the risk of vaccinated individuals catching this variant is higher. Being vaccinated still lowers the risk getting COVID-19, and greatly lowers the risk of suffering from severe COVID-19.
Masking and avoiding large gatherings helps prevent spread during an outbreak like we’re seeing with the Delta variant.
Myth: Getting the COVID vaccine gives you COVID.
Fact: The vaccine is not a live vaccine—it cannot and will not give you the virus.
It instead instructs your cells to reproduce a protein that is part of the coronavirus, which helps your body recognize and fight the virus if it comes along. More here
Myth: The VAERS reporting system has a lot of incidents of death and side effects from the vaccine.
Fact: Reports of death after COVID-19 vaccination in VAERS are very rare—deaths have been reported following 0.0019% of vaccine doses and have not confirmed the vaccine to be the cause.
These reports are not an indication the vaccine caused these deaths. Healthcare providers are required to file a report with Vaccine Adverse Event Reporting System (VAERS) if someone who got vaccinated had a severe adverse event or died, regardless of whether it was caused by the vaccine. Reports therefore include deaths clearly unrelated to the vaccine, and often include information and explicit evaluations by the reporter that the vaccine did not cause the death.
All reports of death are reviewed by the CDC, including death certificates, autopsy, and medical records, and no causal link between the vaccine and death have been found.
The FDA approval of the Pfizer-BioNTech vaccine is based on safety and efficacy data from a clinical trial of 44,000 people, as well as many studies which have evaluated the effects of the vaccine in the population following the initial emergency approval—serious side effects are rare, and the estimated benefits of preventing or minimizing COVID-19 outweigh all known and potential risks.
Myth: The death rate in the U.S. didn’t rise last year, which means COVID isn’t actually that deadly.
Fact: This false claim was retracted.
The false claim was circulating after a non-peer reviewed analysis was published in a student newspaper. It has since been retracted. Unfortunately, COVID-19 outbreaks in the US, like many other countries, have caused a significant rise in deaths and decrease in life expectancy.
Myth: The long-term side effects of the COVID-19 vaccine haven’t been tested.
Fact: The primary time period for assessing the side effects of all vaccines is 1-2 months following administration. The COVID-19 vaccines have been approved for emergency use since December 2020!
Side effects are looked at for 1-2 months because vaccines remain in our body for a short amount of time. Most known side effects of vaccines occur within 1-2 weeks of administration, and all known side effects of vaccines occur within 6 weeks. Some side effects have only been discovered after longer use because they are extremely rare, however these too occurred within 2 months of a person receiving the vaccine.
Over the years many studies have been conducted to evaluate theories suggesting later vaccine side effects, and they have not found such effects.
For additional guidance for vaccinated individuals during the delta COVID-19 outbreaks, see here.