Dr. Jonathan Pinsky of Edward-Elmhurst Health

Pfizer began distribution of its COVID-19 vaccine in the U.S. this week after the Food and Drug Administration issued emergency use authorization, the first for any COVID-19 vaccine in development, for the company’s vaccine.

Suburban Life reporter Joshua Welge got answers to questions you might have about the vaccine from Dr. Jonathan Pinsky, medical director of infection control at Edward-Elmhurst Health.

Welge: Is it safe to get the vaccine?

Pinsky: Before a vaccine can be approved by the FDA, they have to show both safety and efficacy. The first step for the vaccine was to be in preliminary phase 1 and phase 2 trials. They give that to hundreds of participants, and after that they can roll out into a larger study, in this case phase 3, randomized, placebo/control trial.

What that means is the participants in the trial don’t know if they’re getting the vaccine or the placebo, and the investigators don’t know either. That eliminates any bias from the investigators and the participants.

The monitoring board looked at the results, and when there is enough data to show that there is effectiveness, and there are no safety issues, then they can give a green light for the company to submit the emergency use authorization. They had to follow two months of safety data. There weren’t any major adverse reactions in that group of 38,000 participants that had two doses of the vaccine. After that they had to apply to the FDA. The FDA reviewed all the data and came to the conclusion there were not safety concerns.

There were some adverse reactions, but they have to line it up with adverse reactions from the placebo and the vaccine. There was nothing that was more common in the vaccine than the placebo for serious adverse reactions. The only thing that stood out was there were four cases of Bell’s palsy for those that got the vaccine. They concluded that there was no causal link to that reaction.

When you think about safety, you can’t think about it in a vacuum. Is the vaccine safe? What’s the safety of getting it versus not getting it when we’re all exposed to COVID? If you look at people in the vaccine trial, among those that got the placebo 1.3% developed an infection within two months. Compare that to the adverse reactions that were very rare. The adverse reactions are less than 1 in 1,000. From a safety standpoint, it is safer to get the vaccine than to not get the vaccine.

Welge: What are some side effects from getting the vaccine?

Pinsky: The vaccine causes an immune response, and that immune response has symptoms. You can get some pain at the injection site. As the immune response develops, you can get a fever or body aches. These are very common, fever in maybe 15% of people that get the vaccine. These are considered minor, not harmful; they resolve within a day or two. If that happens, you can take Tylenol to blunt the fever; [it] should go away within a day or two.

Welge: When can the general population expect to get the vaccine?

Pinsky: I don’t have any inside information. First of all, they want to get health care workers first. They need to be around patients and take care of patients and are at risk of exposure. From a health care standpoint, the nursing homes, they have outbreaks and a lot of hospitalizations. It will be important to vaccinate this population.

Welge: How much will the vaccine cost?

Pinsky: There won’t be a cost to get the vaccine; this is being provided through the federal government. Possibly, if you get it in a private setting, there may be a charge for administration but not a charge for the vaccine itself.

Welge: Should pregnant women get the vaccine?

Pinsky: The vaccine was not studied in pregnant women. They didn’t want to open it up to pregnant women first in the same way they didn’t open it up to children. There will be ongoing studies for this. We don’t anticipate those studies to be out for months. We don’t want a pregnant woman to not get this vaccine. We recommend that pregnant women have discussions with their health care provider and they can be offered the vaccine as long as they discuss it with their health care provider.

Welge: Should I get the vaccine if I’ve had COVID or been tested to have antibodies?

Pinsky: In this study with Pfizer, they didn’t include people who had COVID, but they checked antibody levels. In the study, there were 1,300 participants who had antibodies for COVID and still received the vaccine and there wasn’t any safety concerns. There were 20 people among the 1,300 group that developed the COVID infection during the study even though they had antibodies. What it did not show is if there was a difference between the placebo and control group with infections, all the infections developed in the group before the last dose. What they suggest is that people that had COVID can still get this vaccine.

The American Conference on Immunization recommends that if you had COVID before you should wait three months to get the vaccine. You don’t have to wait the three months, but the benefit is really going to be the greatest.

Welge: So you should get the vaccine if you had COVID, say, last spring?

Pinsky: I would say yes. Keep in mind it has not been proven, the numbers are too small, but the experts say you should get it if it’s been that long a period of time. We don’t really know enough about reinfections with COVID and how common it is. It’s just that, if you had an infection in March, it’s likely you still have some protections against the virus, but there is still incidents of reinfection and the vaccine is considered safe. The participants that had antibodies didn’t get infections. It’s safe and it’s helpful, so consider it.

Welge: If I get the vaccine, does that mean that I can’t spread it to other people?

Pinsky: We don’t know the answer to that. In this study, what they measured was symptomatic COVID infections. They did not go to any length to look for asymptomatic infections. It’s possible that if you get the vaccine, it will protect you from getting sick, but we do not know if it completely sterilizes the virus. It’s an unanswered question. Big picture, the benefit of this vaccine is not just for the individual that takes the vaccine, the benefit is for the population.

Welge: If I get the vaccine, can I stop wearing my mask?

Pinsky: If you have the vaccine, you still need to wear your mask because others around you haven’t had the vaccine. You could still get the infection and transfer it to someone who might have a severe case. If the majority of the population gets the vaccine, it can’t be transmitted, numbers will go down. That’s the time when we can take our masks off.

Welge: Are you getting the vaccine?

Pinsky: I’m getting the vaccine [this week]. I take care of COVID patients. First, I’ll feel a sense of security that I have more protections, even though I’m wearing PPE. The second things is, I’m excited. This is the first step toward herd immunity. I am setting the example for everyone else. If this continues to roll out, and 80% of the population is immunized, I think we will get back to normal. There will always be areas that will have outbreaks, there is always going to be ongoing risk that COVID could be reintroduced to our community, but with herd immunity it should be limited.

Welge: Will we need to get this vaccine every year like the flu shot?

Pinsky: A couple of differences. First, this vaccine is way more protective than the influenza vaccine. This is 95% efficacy. Influenza shot is 30% to 70%. It’s recommended to get the flu vaccine, but not by any means does it mean you won’t get it. That’s one of the reasons we have influenza.

We have two months of data with the COVID vaccine. What we know is that after the second dose of the vaccine, seven days after the second dose and going two months later, there is 95% protection. We don’t know what the protection will be going forward. Pfizer will continue to monitor the trial and it will be ongoing until everybody gets the vaccine.

The people that received the placebo in the trial, they won’t receive their vaccine until they would normally get it in a phased schedule. They will have data probably going through spring and summer. We’ll have a better answer to that question in the spring and summer when we have more data.