With all eyes on the distribution of the new COVID-19 vaccine and the reopening of many schools depending on it, you could say it’s a hot topic. Tualatin resident Jim Lewis, an infectious disease clinical supervisor at Oregon Health and Science University (OHSU), answers some of our lingering questions on the vaccine. 

Do you believe that the vaccine is safe and ready to be distributed nationwide?

“The thing to remember is that there are roughly 67, at last count, COVID vaccines in some stage of development, so you have to be careful with the question. But the short answer is that the two vaccines that are currently available in the United States from Pfizer and Moderna are outstanding products and are absolutely ready for prime-time.” 

What vaccine brand do you trust the most?

“The only two that are commercially available in the U.S. at this point are [BioNTech-Pfizer] and Moderna. Both of them have been through thorough reviews at the Food and Drug Administration (FDA), and the data have been presented publicly. To be perfectly honest with you, they are hands down the two best first generation vaccines I’ve seen in 20 years of working in infectious diseases. They are bordering on miraculous on how good they are.”

Have you personally received the vaccine yet as you are in the medical field?

“I have personally received the Pfizer vaccine… and I have no concerns about it.”

Some people have voiced concerns about the possible side effects of the vaccine. What is your response to these concerns?

“A vaccine is designed to get your immune system to look at something and go, “Hey, you shouldn’t be here”, and to do it in such a way that you build up protection in case you ever run into the real thing. Vaccines are usually a dialed back version or pieces of the real thing. So of course you’re going to feel like you’ve got a cold, maybe you have a bit of a fever, or maybe you’re tired for a day or two. That’s going to happen because your body is reacting as though it sees a virus or bacteria, something that shouldn’t be there. But that’s exactly how it’s supposed to work…  it’s important to note that maybe 30 percent of people at most experience some sort of side effect and pretty much all of them were mild. There were no bad side effects that popped up in either trial. I can tell you that after my first dose, I had a sore arm. But that’s what happens when you stick a needle into a muscle, right? Especially when compared to what COVID does to old people, which is kill them.”

Why were the vaccines able to be produced so quickly and with such precision in your opinion?

“I think it speaks volumes to the public-private interface that the government put the money out there to allow companies to take risks, because normal vaccine development takes roughly 10 years and this was done in nine months. The reason why was because the government put enough money out there that it took a lot of the risk away from the companies so they could take chances they wouldn’t normally take. And not chances with safety, but chances that something might just not work…. You have to do a ton of work to get [the vaccine] ready to even begin human trials, and all that work is expensive.”

So would you say that the U.S. government incentivized these companies?

“Oh definitely. It’s interesting, Pfizer didn’t take any government money. There’s a 60 Minutes on this that’s a fascinating watch. Pfizer said they didn’t want to be beholden to anybody. Pfizer basically took, according to their CEO, a $2 billion risk. That’s the type of money these companies were having to put in in order to develop this in a nine-month window. To my way of thinking, this is our generation’s version of going to the moon.”

How were they able to pull this off within only nine months? 

“The federal government did change the rules a little bit. All of the normal safety stuff was done… But what the government and the drug companies did was come to an agreement that they could run phase one, phase two and phase three at the same time. So you still had the phase one safety data and at the end of phase one, if there had been any problems they would have shut phase two and three down. But normally what happens is phase one has to finish, you get all the data, you look at all the data, and then you go to phase two. Instead, they ran all three simultaneously.”

Some see the vaccines as experimental since they haven’t existed for much time. Would you agree or disagree? 

“People who say this stuff is experimental, remember that between the two vaccines [Pfizer and Moderna] you have roughly 37,000 patients who were followed for two months, with close follow up, and all that data were presented publicly at the FDA registration meeting. So both vaccines had almost 18,000 [patients who got the vaccine]. So when you put the two together, you have 36,000 people who basically got the vaccines. And there’s no safety signals there. You’ve heard of people getting bad allergic reactions; the incidents of that is 11 cases of bad allergic reactions per million doses.”

Since medical professionals and seniors have been given priority to get vaccinated, have the companies also prioritized those same groups within this test group? Have the younger-aged groups been neglected within the testing because we aren’t necessarily ‘at high risk’? 

“That’s been one of the knocks on a vaccine that we’ve not talked about regarding the AstraZeneca vaccine (not available in the United States yet), which is that they don’t have many patients over the age of 55. But in both the Pfizer and Moderna studies, I believe at least a quarter of the population [they tested] was over the age of 65. So you have good representation of the high risk group, good representation of minorities with a good percentage of LatinX as well as other people of color being included in these studies. The really good news is that for both Pfizer and Moderna, it looks like the vaccine maintains 90 percent efficacy across all subgroups.

Who would you say is the most disproportionately impacted group for this virus?

“I will say that we’re seeing minorities being disproportionately affected. The other thing too is, you get this disease and you’re over age 70 and your death rate goes straight through the roof.… Some of the saddest cases I’ve seen have involved pregnant women. So clearly pregnant women are at high risk, similar to what we see with influenza.”

Since you believe that the vaccine is how we end this and it’s our way back to “normalcy”, do you think that if we all agreed to take the vaccine, we would succeed?

“This is how this ends. How long it takes is dependent on what we as a country and what we as people decide to do.… Based on what I’ve seen, I think we probably need to get around 75 to 80 percent of the population vaccinated.

What about immunity? Do people who have already had COVID need to get the vaccine as well?

“People who have had COVID still need to get vaccinated because there is so much variability in antibody response depending on how bad a case of COVID you had. Whereas if you get vaccinated, we know what your antibody response is going to look like.”

Do we know yet how long immunity from the vaccines will last?

“We still have some unanswered questions though as to how long the vaccine lasts. That’s what a lot of us are worried about at this point. It’s like, ok, are we going to have to vaccinate everybody again in a year?…. We don’t know right now.”

COVID-19 is being portrayed as more aggressive and capable of mutating compared to previous viruses.  Would you say this is true? If so, will the vaccines be able to control it well enough?

“The good news is that this doesn’t seem to mutate as fast as say the flu or HIV. But it does mutate. We definitely got a couple mutants, especially the one out of South Africa right now, that are worrisome.… The preliminary data suggests that both Pfizer and Moderna antibodies are able to neutralize those variants as well, because it’s going to take multiple changes in that spike protein to probably get around the Pfizer and Moderna vaccines.”