On the season premiere of Kentucky Health, host Dr. Wayne Tuckson welcomed Angela Sandlin, PharmD, the pharmacy director at Baptist Health LaGrange, to discuss the safety, availability, and effectiveness of vaccines and medications used for the SARS COVID-2 virus.
Explaining Our Thorough and Safe National Drug Development System
Ever since the SARS COVID-2 virus spread throughout the U.S. in spring 2020, information about medications that could potentially be used to treat the novel coronavirus has been front and center in national news. The media coverage only increased during late fall 2020 and into this year as the first vaccines developed to prevent serious complications from the virus were distributed.
As a result, many people for the first time began paying close attention to how medications and vaccines are developed, tested, and approved, which is a complex process. Dr. Sandlin says the public interest is welcome and that drug approval is something all citizens should learn about.
“The development of a vaccine or any medication goes through a number of steps,” Sandlin says. “The first being an investigational new drug application. That’s the pre-clinical testing, if you will, where [scientists] are testing compounds to see if they have utility. And if they find one that’s hopeful, then they can go into Phase 1 testing.”
Phase 1 testing, Sandlin explains, recruits a small number of healthy volunteers (20 to 80), and they are given the medication and tested for safety. If all goes well, the process moves to Phase 2, involving 100 to 300 patients who have the disease the drug was created to treat. In this phase, the medication is tested for efficacy as well as for any side effects. Control group testing is involved in this phase.
Phase 3 testing involves several thousand patients that have the illness, Sandlin says. This is a diverse group in terms of age and racial background, and the patients also may have different co-morbidities and/or are afflicted with other diseases aside from the one the drug is treating.
“If, and only if, it passes through all of those phases, then it gets a new drug application with the Food and Drug Administration (FDA),” Sandlin says. After detailed review of all research on the drug in question by FDA staff, a decision is made by an advisory group to recommend or deny the drug’s approval. “The FDA usually accepts that recommendation, but that advisory group is made up of physicians, pharmacologists, all sorts of clinicians, scientists, looking at all of this complex data to make sure the medication is safe,” Sandlin says.
Any medications that are approved by the FDA will undergo what Sandlin terms a “post-marketing study.” This compiles data on the drug after it is distributed to thousands of people to keep tabs on any new side effects that may become apparent and to find out if the drug may actually be beneficial in treating other ailments.
According to Sandlin, Phase 2 testing typically lasts two years and Phase 3 lasts three years. It can take an average of 12 years for a medication to move from initial application to the market, and she says that only 1 in 12 medications even make it to the investigational phase.
This term “off label” has been publicized in relation to the SARS COVID-2 virus, and Sandlin explains that it refers to the process whereby medications are used to treat conditions they weren’t initially developed to treat. She acknowledges that prescribing a medication “off label” has led to breakthroughs in medical treatment on occasion. “Technically, physicians can of course go off label – that is something that can be done at the physician’s prerogative,” she says. “But I think prescribers look for evidence, and they do look for other studies being done. …We always go by evidence-based care.”
Two medications that have been in the news over the past year – Hydroxychloroquine, a drug used to treat malaria patients, and Ivermectin, an anti-parasitic drug – have been discussed as effective off-label treatment methods for patients with the coronavirus. Sandlin says that Ivermectin was shown to have some activity against the coronavirus, but only in lab research. “However, so far in the studies, the dose needed to treat (the virus) in someone’s body – which is way different from in a test tube – is very high,” she says. “So there are some different clinical studies going on, but at the same time, using it off label is not recommended.
“One thing we don’t want to do with off-label medications is delay treatment by using an unknown medication when we have known treatments that can work,” Sandlin continues. “And we’ve seen that happen, unfortunately.”
How Vaccines and Medications Can Curb the Pandemic
As the coronavirus swept through the U.S. during spring 2020, the Donald Trump Administration started Operation Warp Speed, a ramped-up, coordinated campaign enlisting the government and pharmaceutical companies to develop, test, and authorize use of vaccines that would fight COVID-19, the disease arising from infection by the coronavirus. The first vaccines for COVID-19 were given in late 2020, meaning the endeavor lived up to its name, and then some.
However, the fast track process to develop and administer the Pfizer, Moderna, and Johnson & Johnson COVID vaccines also generated a high degree of suspicion among millions of vaccine-hesitant citizens who have concerns about their safety. Sandlin says such concerns are understandable, but are not warranted in this case.
“I don’t think we cut corners, I think we cut red tape,” she says. “I think the evidence will show you that it was a collaboration between some wonderful health organizations, the government, and our private industry in developing something and not cutting corners, with all hands on deck.”
Furthermore, Sandlin explains that the underlying structure of both the Pfizer and Moderna vaccines – which is called mRNA technology and modifies part of the coronavirus’ spike protein to induce an immune response within the body – has been researched extensively for several years prior to the pandemic. “We just didn’t have the perfect opportunity, if you will, to try it out – and we were ready,” she says.
Another issue causing concern among some Americans involves the initial authorization of all three COVID vaccines. They were granted emergency use authorization by the government rather than the FDA approval that is normally the final verdict on a drug’s safety. “An emergency use authorization is just what it sounds like – we have a severe pandemic, a problem that is a threat to life and the health of our country and our world, and it warrants us pulling out stops, doing the studies putting this ahead of other things,” Sandlin says. “Emergency use authorization doesn’t mean corners were cut. …I just say that this virus, and these vaccines, were a huge priority because everybody in science knew what a threat it was.”
Sandlin says that the ultimate test of the COVID vaccines’ safety and effectiveness has been proven by the fact that around 200 million Americans have taken them with very rare instances where negative side effects were found.
In addition to the vaccines, as of fall 2021 two medications have become commonly used to treat patients who have COVID-19: Regeneron and Remdesivir. Sandlin explains that Remdesivir is an anti-viral medication that is given intravenously to patients with the coronavirus who have been hospitalized. Regeneron, on the other hand, is a monoclonal antibody drug that is given intravenously to patients soon after they start showing symptoms of COVID-19 with the goal of keeping them from becoming gravely ill and being hospitalized. Sandlin says that Regeneron is primarily given to persons who have high co-morbidities for developing severe illness if they become infected, such as diabetes, high blood pressure, and cancer. Regeneron is most effective if given around four days after a patient is first diagnosed with COVID-19 symptoms, Sandlin adds.
Both Regeneron and Remdesivir are being administered under an emergency use authorization, and Sandlin observes that many persons with COVID-19 who have refused to get vaccinated are more than willing to receive these medications that are also not fully FDA-approved for treatment. “You’re trading one for the other,” she says, “but I’ll tell you, you’re much better off to prevent anything than to wait until you actually have the illness.”
Sandlin says that demand for Regeneron is spiking in Kentucky and other states as more studies show its effectiveness in preventing severe disease from the coronavirus. This has led state officials and medical leaders to explore ways to improve access to Regeneron by distributing the drug to areas where it is most needed and by opening regional infusion centers. “The other thing that has been a challenge for us is having the staff to administer the medication,” she says. “A lot of work is being done on that as we beat this virus back.”
Sandlin has some take-home messages for viewers who have developed a newfound and intense interest in the medication approval process since this global pandemic began. “I can tell you unequivocally that the United States has the safest system for the development of medications in the world – I have all the confidence in that. I have enough experience as a pharmacist to bear that out,” she says. “The medications we use to treat COVID-19 are improving, and the vaccine is the answer to keeping from ever getting COVID in the first place. An ounce of prevention is worth a pound of cure, and that little shot has done a lot of good.”