As we move forward in this pandemic, more and more people are becoming sick with COVID-19, with many dying as well. Thankfully, scientists from around the world have come together to collaborate on vaccines, 2 of which are already being rolled out in the United States.
While reading this, keep in mind that the US has over 23 million cases and greater than 400,000 deaths within ten months. Globally, there have been over 90 million cases and about 2 million deaths. The primary objective of getting a vaccine is safety. Keeping yourself and those around you (who might not be able to get a vaccine at this time, like children) protected is the number one priority.
What vaccines are available currently?
As of January 15th, the FDA has granted an EUA for two vaccines. One is from Pfizer, a biopharmaceutical company, in collaboration with BioNTech, a biotechnology company. The other approved vaccine is from Moderna, another biotechnology company.
How were vaccines developed so quickly?
Because of the widespread global effects of the coronavirus pandemic, global research and collaboration was done in order to safely and effectively develop vaccines. Globally, scientists and researchers worked together to contribute to vaccine development, research, clinical trials, and distribution methods. mRNA vaccine technology has been worked on for years. Because COVID-19 is a coronavirus, researchers and scientists were able to build off of another coronavirus study that began research in 2002. The sequence of COVID-19 was discovered and immediately shared with others roughly 10 days after the first suspected case in Wuhan, China. Fast-tracked clinical trials and research was due to worldwide cooperation between scientists. Funding for the research and trials was also increased. The urgent need for a vaccine gave various governments around the world a great reason to push large amounts of money into research and development.
BioNTech and Pfizer Vaccine Timeline
BioNTech began working on a vaccine in January of 2020 after one of the founders was convinced COVID-19 would become something larger than only a problem in China. In March, Pfizer and BioNTech began to work together on a vaccine. In May, the two companies launched phase 1/2 combined trials (more on combined trial phases here https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html#pfizer) on two different versions of an mRNA vaccine. One version, the currently available version, had fewer side effects. In July, the companies launched phase 2/3 trials with over 30,000 participants in the US and other countries such as Argentina, Brazil, and Germany. In September, the US trial was expanded to 44,000 patients. In November, preliminary data shows that their vaccine is over 90% effective with no serious side effects. Final data shows a 95% efficacy rate. On December 11th, the FDA grants an EUA and vaccinations began on December 14th.
Moderna Vaccine Timeline
In January 2020, Moderna begins to work on their vaccine. In March, their vaccine is the first COVID-19 vaccine to be put into human trials. In April, Moderna partnered with the National Institute of Health (NIH) who oversaw most of the research and trials. In July, phase 3 clinical trials begin. On November 16th, preliminary data shows roughly a 94% efficacy rate. In early December, Moderna registers a trial for children ages 12-18. On December 18th, Moderna was granted an EUA by the FDA and vaccinations began on December 21st.
What is an EUA? Does it mean the vaccines have not been adequately tested?
EUA’s are granted in emergency situations in which treatment is needed as fast as possible. This however, does not mean the vaccines are not safe or have not been adequately tested. EUA’s have been granted as data from the manufacturers and clinical trials have shown the vaccines to be safe and effective. The CDC states that the potential side effects known from the vaccines outweigh the harms and risks of contracting COVID-19.
What limitations do the vaccines have?
While extensive clinical trials and research have been done already, both vaccines currently available have some limitations. The Pfizer-BioNTech vaccine is currently approved by the FDA for those 16 years of age and up, with the Moderna vaccine being approved for ages 18 and up. Anyone with known side effects to ingredients in the vaccines should also not take them at this time (Ingredients of authorized vaccines can be found on the FDA’s website). There are also limitations on a local and state based health capacity for distribution as well. Pfizer’s vaccine must be stored at roughly-70 degrees Celsius, colder than winter in Antarctica. Moderna’s vaccine only needs to be stored at -20 degrees Celsius. In addition, both of the vaccines require two doses to be fully effective.
How do the vaccines work?
The vaccines themselves are mRNA vaccines encoded with spike proteins similar to those of the actual COVID-19 virus. This does not mean that the vaccine contains a weakened or inactive virus, similar to that of other vaccines you may be familiar with. The COVID-19 vaccines do not contain the virus at all, but rather instructions. The instructions contained in the vaccines introduce a similar structure to the spike proteins on the COVID-19 virus into your body, allowing your body to build an immune defense against viruses with the spike structure. This means that when/if your body comes into contact with the COVID-19 virus and it’s spike proteins, your body will know how to fight it off.
Safety and Effectiveness
Now that you know how the vaccines work, let’s take a look at their safety and efficacy. mRNA vaccines are fairly new to the vaccine world, but researchers have been working with them for many years. They can be easily developed in laboratories, which is why the COVID vaccine was able to be developed so quickly. As soon as scientists got the DNA structure for the virus, they were able to replicate the mRNA sequence in a lab. mRNA vaccines are strongly regulated by the FDA and held to the same standards as any other vaccine currently available. The Pfizer vaccine is 95% effective against preventing COVID-19, and the Moderna vaccine is 94.1% effective. These percentages are actually extremely good, as scientists were expecting around 50% efficacy rate.
Efficacy vs Effectiveness
Efficacy can be defined as the performance under ideal and controlled conditions, whereas effectiveness takes into account real world conditions. A 94-95% effectiveness is an extremely high rate and much more effective than scientists initially believed.
The most commonly reported side effects of the Pfizer/BioNTech vaccine (which typically last several days) include pain at injection site, tiredness, headaches, muscle pain, chills, joint pain, and fever. The FDA notes that more side effects were reported after the 2nd dose, however side effects after both are still possible.
The most commonly reported side effects of the Moderna vaccine (typically lasting several days) include pain at injection site, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm as injection, nausea and vomiting, and fever. These symptoms are also more likely to appear after the second dose, but should be expected after both.
It is also important to remember that just because these vaccines have been granted EUA’s, that does not mean safety tests or clinical trials will stop. Neither of these vaccines is approved for children under 16 currently, and those trials are going on now. Side effects are also continuously monitored and taken into account.
Hesitancy to Vaccines
Due to the extremely fast development of the vaccines, many are hesitant as to whether to get a vaccine or not. The development timeline combined with the ever-growing anti-vaxx movement contributes to a lot of hesitancy and misinformation around these vaccines.
To be clear, the vaccine does NOT contain COVID-19 at all. It simply contains harmless instructions for a spike protein similar to that on the COVID-19 virus. Mutation rates should also not be a concern, and the mutation rate of COVID-19 is less than that of other viruses, such as the flu. There is also no evidence to show that the vaccines will not protect against mutations.
Natural immunity is also not a sufficient way to build herd immunity. Allowing the virus to spread rampant would cause many unnecessary deaths, which is both problematic and unethical. It is unclear after having the COVID-19 virus how long your body builds up immunity. Herd immunity can rather safely be achieved after a certain amount of people have been vaccinated. The exact percentage of vaccinations needed to reach herd immunity is unclear at this time. However, when people are hesitant to take the vaccine, it is much harder to reach any percentage of herd immunity. Herd immunity is designed to keep those who are physically unable to get vaccinated safe, not so that those who refuse to believe in science can be safe as well.
Getting a Vaccine
After becoming available to you in your state during phased rollouts, you will most likely have to sign up to receive your first dose of a vaccine. After receiving your first dose, it is imperative that you continue to social distance, frequently wash your hands, wear a mask, and follow any related government-issued orders.
Side effects are not uncommon, even with other existing vaccines such as the flu vaccine. For that reason, there should be no fear of the common side effects.
Depending on the vaccine you recieve, you will then go back for a second dose either 21 days later (Pfizer) or 28 days later (Moderna). Even after you receive both doses of a vaccine, it is still important to social distance and continue to wear a mask until it is designated safe by officials, which likely won’t be until much later this year (although a timeline is not sure).
Why is all of this important?
For not only personal safety, but the safety of others, it is vital that if you are able, you should sign up to receive a vaccine. Public health officials are doing everything possible to keep us safe, and you can be assured that these vaccines are held to no different safety standards than other vaccines. Again, it is important to follow federal, state, and local guidelines even after getting vaccinated. These vaccines are not 100% effective, although no other vaccines can be 100% effective, so wearing a mask and social distancing is extremely important until designated otherwise by government officials.
It is also important to be personally educated about what the vaccine is in order to speak with those hesitant to vaccines. In addition, speaking to an anti-vaxxer on vaccines and speaking to a Black person about vaccines are two completely different situations and should therefore be handled differently.
Being vaccinated is something that you must do (if you are able) in order to protect yourself and your community. These vaccines were developed safely and effectively, and will continue to be monitored for safety purposes. You can be assured that these are safe, as many public health officials and other prominent figures such as newly inaugurated President Joe Biden and Vice President Kamala Harris have received either 1 or 2 doses already. Again, the most important thing to everyone is keeping people safe. To prevent unnecessary death and suffering, we must do as we are advised and take recommended measures. So, when the opportunity arises, you are strongly encouraged to do what is best, and receive a vaccine.
For further personal research or questions you may have: