By Vivian Roach | Staff Writer
The first COVID-19 vaccines have been rolled out for distribution in under a year since the global pandemic hit. Speculation surrounding its legitimacy and safety have made people wary of getting it.
Dr. Emily Smith, Baylor Robbins College of Health and Human Sciences assistant professor of epidemiology in the department of Public Health, said though it seems the first COVID-19 vaccine has made it to distribution rather quickly, there have been no corners cut.
“The background work, foundational science work has been going on for a long time to develop these sorts of vaccines. And so by the time 2020 came, years of that work already had taken place. It catapulted the ability to actually test these vaccines,” Smith said.
Dr. Peter Hotez, dean for the National School of Tropical Medicine (NTSM) at Baylor College of Medicine, and Dr. Maria Elena Bottazzi, associate dean of the NSTM, said they have been working on the coronavirus vaccine for at least a decade and a half. It’s this particular strain of coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that had only just been identified in 2019, and later declared by the World Health Organization (WHO) the outbreak a pandemic.
“It’s not like we started from scratch. We already had a lot of knowledge and that’s probably one of the reasons why it moved so quickly,” Bottazzi said.
Vaccines are developed in several stages. The clinical development stage happens in three phases of trials in which the vaccine is tested on people.
“When it gets to the trials, that’s where the scientific trust comes in because it goes through the phase one trials and then the phase two trials, with increasing people in each. By the time it gets to phase three, it’s at least 30,000 [people]. It could be up to 60,000 in some trials, where they are doing the type of studies that you need for the most rigorous legitimacy,” Smith said.
Those later studies are double-blind, placebo controlled studies. They best guarantee legitimacy because any unconscious bias from researchers and participants is eliminated. Participants don’t know if they’re getting the real treatment or a placebo, which is designed to look like the real thing. Furthermore, the researchers are also unaware of whether they are distributing the real or fake treatment so there’s no preconceived notion about their results.
“By the time you get to the endpoint, you have a pretty good idea of whether or not that vaccine is going to work or not. So, that is what has happened, and the vaccines work phenomenally when it’s gone through the right channels, which they have,” Smith said.
The point of the phase three trials is ultimately for the last phase, phase four, which is more surveillance of a vaccine. Smith said phase three trials look at any side effects, large or small, to be on the lookout for when they roll it out to the general public. Now, there is tracking technology, like the app V-safe, which encourages people to report any side effects they have after being vaccinated for COVID-19.
“Once you get a vaccine you can report anything. They actually encourage you to report if you have soreness. Do you feel feverish, did it make the injection site a little red, all the way up to more severe ones that are rare,” Smith said. “That makes me trust the vaccines because the whole point of that surveillance system is if something were to happen, then that is the system in place to catch it and stop distribution.”
In a morbidity and mortality weekly report from the CDC on Jan. 15, a small amount of allergic reactions including anaphylaxis were reported from the first doses of Pfizer-BioNTech COVID-19 vaccine. There were 21 cases of anaphylaxis out of 1,893,360 first doses of the vaccine. The report also said that 71% of these reactions occurred within 15 minutes of vaccination. 17 of these cases were from persons with a documented history of allergies or allergic reactions, seven of whom had a history of anaphylaxis, including from rabies and influenza vaccines. Twenty are known to have been discharged home or recovered at the time of the report.
Additionally, the report said the CDC and FDA received reports of the anaphylaxis case incidents from multiple different sources, including direct outreach from medical staff. Included, the Advisory Committee on Immunization Practices reported clinical considerations for the vaccine should have the proper equipment to treat severe allergic reactions and should do so immediately, as well as post observation.
Smith said she gets questions all the time asking if the vaccine is safe for people with allergies to eggs, shellfish or Benadryl, but the CDC has said that even people with those specific allergies should look into getting vaccinated.
“No one has died from the vaccine, for one,” she said, “and I would be careful to say that people can’t get it if they’re allergic to certain things, because the anaphylaxis is just not that prevalent at all.”
The CDC said as interim clinical considerations, allergic reactions not related to vaccines or components of a vaccine are not determined to be precautions to people getting vaccinated. Since the vaccine does not contain eggs, natural rubber latex or gelatin, medical professionals are not concerned that people with those allergies are at higher risk to an allergic reaction.
Vaccine surveillance educates the regulators to determine whether it should still be in use, or in the COVID-19 case, under emergency authorization, Bottazzi said. The more data that is compiled, the more validation scientists have in the vaccine. Again, according to the surveillance data so far, Bottazzi said there hasn’t been anything major.
“I even signed up for that V-safe app. Every day I get a message that says, ‘Please tell me if you have any symptoms. Do you feel this? Do you feel that?’” Bottazzi said. “There’s going to be continuous compilation of safety information. That’s why we encourage people to connect with the app or any of these reporting systems because that’s where we understand how these vaccines are causing anything.”
Phase four virtually lasts forever, Bottazzi said.
“It never stops. Even other vaccines that we already have, that we use, they always look at and are compiling additional safety data. Some vaccines have years and years of compilation of safety data because we’ve used them for 50 years. The COVID vaccines we started now, and so it’s going to go on and on for a long time,” Bottazzi said.
Other vaccine safety procedures, like the Global Vaccine Safety Initiative (GVSI), started in 2011, are dedicated to providing a global “safety net” for vaccine distribution activities. The WHO and other partners have developed eight objectives in their “Global Vaccine Safety Blueprint” strategic document to be tailored by country for at least base-level vaccine safety in the lowest-income countries.
Bottazzi said this initiative is good because the safety objectives can be country-specific, which is important because all countries could respond differently depending on various factors.
For example, Smith said other countries like Taiwan and New Zealand have slowed the pandemic enough, so the vaccine is treated differently there.
“When they are vaccinating people, it’s imperative to do it because you want to reach herd immunity, but it’s not as imperative as it is here in the U.S. because we just have to get the cases down quick,” Smith said. “These vaccines protect us for sure from severe disease, but the longer that we see cases as high as they are in the U.S., the more risk that we’re putting on not only our hospital system to be overloaded but also the risk of mutations happening. The sooner that we can get the cases down through those vaccines and also through tried and true wear of your mask and distance — vaccines are not going to get us out of this pandemic — the more likely that we can get to herd immunity.”
Herd immunity is when a large part of a population is immune to a disease. Consequently, transmission is decreased and eventually interrupted, Bottazzi said.
“If you have all these viruses in the community because many people are transmitting it, I transmit it to you, you transmit it to three more and three more transmit it — it’s exponential. If I start vaccinating, first of all, it prevents me from getting sick, and by preventing me to get sick it means that when I have the virus inside me, I’m not going to transmit it as much as if I didn’t get the vaccine because it attacks and at the end of the day, kills the virus,” Bottazzi said.
Those who get immunity from a vaccine create community “bubbles,” she said. They’re the key to protecting not only yourself but also those individuals who can’t get the vaccine: young kids, the elderly, immune-suppressed people and cancer patients.
“For example, your grandfather, not only because he’s old, but mostly because his immune system is not very good and probably is not going to react as well with the vaccine, or maybe he’s on some medicines or he has other diseases,” Bottazzi said. “For those people, clearly there’s no way for them to be protected with the vaccine, but if they’re surrounded by people that actually have been vaccinated, there’s not a lot of virus transmission … You’re creating this bubble for the entire community.”
That’s the important part to understand about vaccines, Smith said.
“At least from my perspective as a Christian, the more of us that get vaccinated, the more of a safety net there becomes for the rest of the population of those who can’t get the vaccine for whatever reason,” Smith said. “It’s a way of protecting our neighbors.”
Additionally, the longer a virus circulates and transmission goes uninterrupted, the more chance it has to mutate into a more contagious variant, Smith said, like the ones recently found in South Africa, Brazil and the United Kingdom.
There’s an urgency now to vaccinate about three quarters of the U.S. population by the summer, Hotez said, in order to get ahead of the South African variant before it’s widespread.
“Unfortunately, against the new variants, the vaccines are not quite as effective,” Hotez said. “The question then is going to be, do we redesign all the vaccines now to protect against both the original and South African, or do you go ahead and start vaccinating with the original, in order to try to halt transmission and then start developing, as a boost later on?”
In a recent research article to be published in the American Journal of Preventive Medicine, Hotez and Botazzi contributed to a study on the benefits of vaccinating with the first available COVID-19 vaccine. Though first generation vaccines are not always as effective as those still in development, the researchers found that in most of the situations, using the first available vaccinations resulted in lower hospitalizations and costs.
In the discussion, the researchers wrote that “this is because as the pandemic progresses and there are more and more cases each day, the potential gain from a higher-efficacy vaccine is offset by the rise in additional cases, hospitalizations, and associated costs.”
At the end of the day, an integrated approach has to always be taken to combat viruses, Bottazzi said. Being able to use health tools, like masks, distancing, hygiene and good information along with vaccines is what really interrupts these outbreaks.
“The reason why we were able to stop SARS and MERS is because we had very good contact tracing following it. Therefore, we didn’t let it spread, and we use tools that were really successful at interrupting,” Bottazzi said. “Some are easier to control than others.”
