Information about the COVID-19 vaccine
The vaccine development process typically takes 15 years, with each step (early research, early testing, Phase 1 trials, etc.) taking years. The COVID 19 vaccine development has taken less than one year. How? What has allowed the development of this vaccine to occur at warp speed? Money and Manpower! Never before (and I mean that) has so much money and manpower been thrown to a cause, which has reduced risk for the companies producing the vaccine and cut through administrative red tape.
Let’s talk more about the steps of vaccine development. Early lab research takes many years, starting from the idea of a vaccine to finding a possible way to create it. After the research is completed, initial safety testing is performed. If that goes well, the vaccine goes into Phase 1 human clinical trials which involve <100 people. The point of Phase 1 trials is to test the safety and check whether the vaccine works. After a few years, if all goes well, Phase 2 trials are started. Phase 2 trials enroll a few hundred people, and test not only if the vaccine works, but determines what dose is best (think 10mL vs. 0.1mL). Phase 3 trials involve a few thousand people, and then the licensing process takes another few years.
For the COVID vaccine, much of the early research and safety testing had been completed already. Do you remember the SARS outbreak of 2002-2004? That outbreak was caused by a coronavirus and although the virus naturally died out in 2004, vaccines started to be developed. At that time, researchers had identified the main protein that caused the coronavirus to infect cells, and thankfully, the current coronavirus carries the same protein. Therefore, much of the early vaccine research and safety trials were already completed, and Phase 1 COVID vaccine trials started in March of this year. Phase 2 trials started a few months later. Phase 3 trials have started while Phase 2 trials are continuing. This overlap in scheduling does not normally happen, but it has allowed for much faster vaccine development. Click here to read more about the vaccines that are in development (article is from 10/2020).
- It is very difficult to explain how an mRNA vaccine works without pictures. Lucky for you (and me!) the New York Times did a great job of illustrating this, so check out this awesome NYT article on how mRNA COVID vaccines work.
- mRNA vaccines are new. Why was this type of vaccine chosen? Well, it is likely we would have had an mRNA vaccine for a different infectious disease because this type of vaccine has been in development for decades. For example, researchers are working on an mRNA vaccine for the Zika virus. How did the COVID vaccine beat Zika to become the first mRNA vaccine? MONEY and the removal of administrative red tape. No, the trials did not cut corners. The trials enrolled tens of thousands of people of all races and a review of the trials show they were done well and the results are reliable. We can also produce mRNA vaccines quickly and at a reasonable cost.
- Is it safe? We certainly think so! If you are offered the COVID vaccine and feel like you may have side effects, please download the V-safe app which tracks side effects for the COVID vaccine. So far, there have been very few allergic reactions to the vaccine, in fact, there have been 6 severe allergic reactions out of 250,000 vaccinations as of Saturday. There were a few cases of Bell’s palsy (paralysis of half of the face) but thankfully it is not life-threatening although it is uncomfortable. There are also lots of people with sore arms which is a good thing and means the vaccine is working. Best of all, these reactions are similar to what we have seen with other vaccinations.
- What about pregnant or breastfeeding women? Check out this link to find out what we know. I recommend that pregnant or breastfeeding women register at this website if they decide to get the COVID vaccine so that we can track how they do.
- What about kids? Well, there hasn’t been a lot of research done with kids and the COVID vaccine. While there were a lot of adults jumping at the chance to join a COVID vaccine trial, parents would have to allow their children to join a vaccine trial. So for now, until trials with children can be done, there is no vaccine for them.
- When will we be able to stop wearing masks and social distancing? I’m going to guess 6-9 months, but a lot can happen between now and then. Enough people need to be vaccinated in order to start to produce herd immunity.
- Finally, I hesitate to include this last point, but I’m trying to include as much information as I can. I’ve gotten some questions from people who have heard that aborted fetuses were used in the development of this vaccine. ZDoggMD provided a very good (and animated) overview of the issue of vaccines and abortion in a video HERE.
Have a great week!
Melissa Boylan, MD, FAAFP