An Interview with Mary Moran

Q: Tell me about yourself - your job at Pfizer and what you do?

A: “I am a pediatrician by training. I am a North American medical lead for viral vaccines. I had a career in academic pediatrics but joined the vaccines team two years ago. I used to work on the pipeline vaccine for Pfizer (ones that are being worked on) and then was assigned to the COVID vaccine.”

Q: What is a vaccine and how does it work? What is the usual process?

A: “There are generally two types of vaccines, ones that are licensed and ones that are not (approved/authorized for emergency use). The ones that are not licensed, like the COVID vaccine, have been developed quickly and rigorously.”

“Usually, vaccines start with preclinical development, meaning they are tested in animals. It usually takes over ten years for a vaccine to get approval.”

“The mRNA vaccine was completed in one year. The clinical trials happened with the same rigor, but instead of doing it sequentially, the vaccine was developed in parallel. So they tested (and continue testing) different doses of a vaccine in three or four different age groups with different vaccine schedules.”

“Unlike usual vaccines, the manufactures and government made vaccines and bottled them even before they worked as a “just in case it does” measure. This usually never happens because that could have been billions of dollars wasted. But what happened was that the government and other pharmaceutical companies gave the money upfront, asking for vaccine doses so that they could store them, even before they knew it worked.”

“For the COVID vaccine, pharmaceutical companies ran clinical trials on volunteers with close observation under the FDA approval. During these clinical trials, volunteers reported any symptoms immediately.”

“Vaccines, in general, mimic a natural infection. Vaccines use part of a germ (virus or bacterium) that has been weakened. This gets injected into the person and the person forms antibodies. The body activates t and b cells which serve as “memory” cells. When it recognizes the germ under normal circumstances, it produces normal antibodies and produces t cells.”

“mRNA vaccines are a new “platform” or vaccine technology. I will make an analogy that mRNA is like a “recipe”. You start by taking a piece of mRNA that is made from the virus DNA. For coronavirus, the spike protein is responsible for making you sick. So if you take the DNA from the spike protein of the coronavirus and make an mRNA template from the DNA and inject this transcript or “recipe” into your cell, it will get translated into a spike protein (via the ribosomes). The spike protein gets produced by your body and the cell recognizes the spike protein as foreign. Once exposed to the novel virus, you are good to go. This new technology allows us to make vaccines faster.”

“I keep referring to mRNA vaccines as “new” but they are not really that new of a concept. mRNA vaccines have been studied for 3-4 decades, but in vaccine time this is very young. There have been no mRNA vaccines produced before for licensed use. But COVID made us realize that we need to create something immediately.”

Q: How long did it take to develop?

A: “It took 9-10 months and it started in March 2020, and by December 2020 we got approval.”

Q: Are the vaccines safe? What kinds of side effects do they have?

A: “All the vaccines are pretty much the same. The standard side effects are headache, fever, chills, tiredness, and pain at the injection site. There definitely is a possibility of other unknown effects. The Vaccine Adverse Event Reporting System (VAERS) is where recipients report any effects of having the vaccine (or any vaccine for that matter).”

“With the pandemic, the CDC formed VSAFE, which is a means to get new information or report any symptoms.”

“There is also a pregnancy registry - pregnant women experience COVID much harsher than those who are not pregnant so we are watching them very closely.”

Q: By getting the vaccine, could the recipient fall sick?

A: "No, because we’re not using the virus. It doesn’t contain SARS-CoV-2. Those who are thinking about taking it should consider their own medical conditions and the severity of the disease. But ultimately, it is still the individual’s decision.”

Q. Anything else that you would like to add?

A: “Pharmaceutical companies are looking at the vaccine in the younger population and are actively conducting research and trials.”