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Specialty Pharmacy Continuum • March/April 2021
POLICY
FDA Grants EUA for Third COVID-19 Vaccine February ended in a flurry for the FDA and the Janssen COVID-19 vaccine. In the space of three days, an FDA advisory committee unanimously recommended an emergency use authorization (EUA) for the vaccine, which the agency then granted, followed by the Advisory Committee on Immunization Practices (ACIP) endorsing the safety and effectiveness of the vaccine for people aged 18 years and older. “This third safe, effective COVID-19 vaccine comes at a potentially pivotal time. CDC’s latest data suggest that recent declines in COVID-19 cases may be stalling and potentially leveling off at still very high numbers. That is why it is so critical that we remain vigilant and consistently take all of the mitigation steps we know work to stop the spread of COVID-19 while we work our way toward mass vaccination,” said CDC Director Rochelle P. Walensky, MD, MPH, on signing the ACIP’s recommendation. “As vaccination scales up, so too does our nation’s overall protection from serious outcomes due to COVID-19,” she explained. Calling the vaccine an “important tool in our toolbox,” Walensky said the vaccine has some advantages over the Pfizer/BioNTech and Moderna vaccines. Because it is a one-dose vaccine, “people do not have to return for a second dose to be protected. In addition, this vaccine does not need to be kept in a freezer and can be stored at refrigerated temperatures—so it is easy to transport and store and allows for expanded availability in most community settings and mobile sites, as supply scales up,” she said. The FDA determined that the Janssen COVID-19 vaccine met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Janssen vaccine may be effective in preventing COVID-19. The data also show that the vaccine’s known and potential benefits outweigh its known and potential risks, supporting the company’s request for the vaccine’s use in people 18 years of age and older, the FDA said in a statement. The Janssen COVID-19 vaccine is manufactured using an adenovirus type 26 (Ad26) to deliver a piece of the DNA that is used to make the distinctive “spike” protein of the SARS-CoV-2 virus. While adenoviruses are relatively common, Ad26, which can cause cold symptoms and pink eye, has been attenuated for the vaccine so that it cannot replicate in the human body to cause illness. After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease, but triggers the immune system to
learn to react defensively, producing an immune response against SARS-CoV-2.
A Pivotal Multicenter Trial The decision to grant the EUA was based in part on an analysis of 43,783 participants enrolled in the ongoing ENSEMBLE trial, a randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico and the United States. The participants, 21,895 of whom received the vaccine and 21,888 of whom received saline placebo, were followed for a median of eight weeks after vaccination. Overall, the vaccine was approximately 67% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination. Additionally, the vaccine was approximately 77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/ critical COVID-19 occurring at least 28 days after vaccination. There were 116 cases of COVID-19 in the vaccine group that occurred at least 14 days after vaccination, and 348 cases of COVID-19 in the placebo group during this time. There were 66 cases of COVID-19 in the vaccine group that occurred at least 28 days after vaccination and 193 cases in the placebo group during this time period. Starting 14 days after vaccination, there were 14 severe/critical cases in the vaccinated group versus 60 in the placebo group, and starting 28 days after vaccination, there were five severe/ critical in the vaccine group versus 34 cases in the placebo group. Data are not available to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person, the FDA said. The most commonly reported side
effects were pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects were mild to moderate in severity and lasted one to two days. As part of the authorization, Janssen Biotech Inc. and vaccination providers must report serious adverse events following administration to the Vaccine Adverse Event Reporting System (VAERS) for the Janssen COVID-19 vaccine. Those include serious adverse events, cases of multisystem inflammatory syndrome and cases of COVID-19 that result in hospitalization or death.
Strength in Numbers Public health experts applauded the availability of the new COVID-19 vaccine. “Having different types of vaccines The Janssen COVID-19 vaccine is
67% effective overall in preventing moderate to severe COVID-19 occurring at least 14 days after vaccination and
66% effective at least 28 days after vaccination.
available for use, especially ones with different dosing recommendations and storage and handling requirements, can offer more options and flexibility for the public, jurisdictions and vaccine providers,” Walensky said. “Getting vaccinated with the first vaccine available to you will help protect all of us from COVID-19.” “The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” added acting FDA Commissioner Janet Woodcock, MD.
Johnson & Johnson said it was committed to making its COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use. The company has begun shipping its COVID-19 vaccine and expected to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million Americans. In March, President Joe Biden called on state, local and tribal governments to enable access to all American adults eligible to sign up for COVID-19 vaccines by May 1.
What About Pharmacists? In related news, the first public meeting of the COVID-19 Health Equity Task Force was held on Feb. 26, and although several initiatives were announced, including addressing inequities related to COVID-19 vaccination, there was one glaring error: not having pharmacists involved in potential solutions, according to a letter ASHP sent to the Biden administration. In the letter, ASHP asked the administration to add pharmacists to the group charged with addressing health inequities caused or exacerbated by the COVID-19 pandemic. “I am greatly concerned that despite the role pharmacists are playing in COVID-19 vaccination and treatment, and the relative accessibility of pharmacists in otherwise underserved communities, this task force does not have a single pharmacist among its members,” said ASHP CEO Paul Abramowitz, PharmD, ScD (Hon). “This deprives the task force of insights from medication use experts and the most accessible providers in underserved communities.” Other sectors of the government seem to better grasp the value pharmacists bring to vaccination efforts. In March, the Department of Health and Human Services expanded its guidance on clinicians who can administer COVID-19 vaccines to include recently inactive pharmacists (active and in good standing within the last five years) and pharmacy interns. —Marie Rosenthal, David Bronstein The sources reported no relevant financial disclosures.
