Forbes: Worried About The Safety And Effectiveness Of The Covid-19 Vaccine? The SAVE Act Aims To Make Transparency A Priority
As Russia debuts its new Covid-19 vaccine, Sputnik V, and begins to inoculate some of its citizens without extensive testing regarding its safety or efficacy, concern regarding the pressure to get a vaccine safely to market here in the United States via Operation Warp Speed has many people concerned, and rightfully so.
While vaccine trials typically take many years until a viable vaccine comes to market, the reality is that these are not normal times. But the process to produce a safe and effective vaccine also shouldn’t be compromised. With respect to the debut of the Russian vaccine, it’s important not to be just first, but to be safe and effective by investing in sound Phase 3 trials. Simply put, we don’t want to expose people to a vaccine until it is thoroughly tested and we have the data to support its widespread distribution. First and foremost, we do not want vaccinate children and older persons if there is any concern that it could potentially do harm.
But bringing a vaccine to market in such a short period of time requires appropriate monitoring and transparency—akin to a “check and balance” to maintain public confidence in the regulatory process.
One such approach is the introduction of the SAVE Act—The Safe Authorization for Vaccines during Emergencies Act. It represents bipartisan legislation that aims to improve public confidence in a potential Covid-19 vaccine by increasing the transparency of the vaccine approval process. The legislation is especially timely, as Phase 3 trials in the US began for several vaccine candidates last month.
Sponsored by U.S. Senators Maggie Hassan (D-NH), Mike Braun (R-IN), and Lisa Murkowski (R-AK), its legislative goal is to simple: increase transparency of the approval process by providing the public data and facts during the approval process itself, helping to improve confidence that Americans will accept a vaccine when it is finally approved.
“As we work to get a potential vaccine approved, produced, and distributed as quickly as possible, it’s critically important that the public is confident that the federal government followed the necessary protocols to ensure that the vaccine is safe and effective,” Senator Hassan said in a recent press release. “This bipartisan bill would ensure that key oversight mechanisms of the vaccine approval process stay in place, and that recommendations provided during this process are publicly available, even during an expedited vaccine approval process. We will push for this bill’s inclusion in the upcoming COVID-19 relief package.”
The SAVE Act would essentially define the current operating rules and processes within the CDC and FDA for review of vaccine candidates. It would also spell out the requirements that the CDC’s Advisory Committee on Immunization Practices (ACIP) and FDA’s Vaccine and Related Biological Products Advisory Committee each must satisfy in order to produce recommendations regarding the safety and efficacy of vaccine candidates seeking emergency use authorization (EUA). It would also make sure that public recommendations regarding safety related to specific groups for immunization are issued by these two committees.
“When a COVID-19 vaccine comes to market, Americans need to be confident it is safe and effective for their families,” said Senator Braun. “The SAVE Act makes the vaccine approval process transparent so Americans can see CDC’s and FDA’s rigorous review process for themselves as a vaccine gets closer to market.”
“This bill makes sure that federal regulators do their part to ensure that a safe and effective vaccine will be deployed to the public in a timely manner. It also ensures that the regulatory approval process for any potential COVID-19 vaccine is efficient—and not slowed down by regulatory hurdles that have nothing to do with safety and effectiveness,” added Senator Braun.
Senator Murkowski emphasized that “my focus right now is providing all Americans with the resources and support they need to address the impacts of the COVID-19 pandemic, including supporting efforts to help develop a vaccine. Equally important, is that a vaccine is safe and effective, and that people trust it.”
“Our bill works to ensure that the vaccine approval process is clear and transparent, giving Americans the confidence they will need in making decisions once we have a successful vaccine,” she added.
While it’s important to understand that such bipartisan legislation would not compromise the speed of the current vaccine approval process, it would guarantee that transparent committee meetings occur—but if they don’t for some reason—the Secretary of Health and Human Services (HHS) would be required to provide and explanation for such a decision.
Senator Hassan has made it a priority to push for funding and safety measures in the ramp up to a potential vaccine candidate. Along with 27 other colleagues, last month she called for Congress to provide at least 5.6 billion dollars in federal funding to support and develop Covid-19 vaccine infrastructure. In early May, during a Senate Health, Education, Labor, and Pensions Committee hearing, Senator Hassan asked Dr. Anthony Fauci what is necessary to mass produce and distribute a Covid-19 vaccine candidate. In early April, she also called on the Trump administration to look into concerns related to domestic supply chain for hypodermic needles and syringes necessary to administer a potential Covid-19 vaccine.
“Gaining the confidence of the public in a potential COVID-19 vaccine is mission critical if we want to ensure a high rate of vaccination; yet currently, many Americans are unsure if they are willing to get it if one becomes available. It’s clear to me that ensuring proper review of data will help ensure that any vaccine that enters the market is safe and effective, and will also lead to a higher level of public confidence in the vaccine,” said Dr. Joseph Sakran, Director of Emergency General Surgery at Johns Hopkins Hospital.
“Senator Hassan’s bipartisan bill allows for emergency authorization of vaccine products while combining some of cornerstone pieces that exist during normal licensure. This will also allow healthcare workers to instill the necessary confidence patients often need when they look to us for advice,” added Sakran.
William A. Haseltine, PhD, Chair and President, ACCESS Health International and a Forbes Healthcare contributor, explained that “legislation is required to assure that any Covid-19 vaccine approved for use in the United States, including emergency use authorization, meet the FDA requirements for a vaccine to be used for young children, and older adults. Otherwise, vaccines of unknown safety and efficacy may be approved for political, electoral, or economic reasons independent of either their known safety and efficacy.”
While the technology behind Sputnik V is reported to resemble Astra Zeneca’s vaccine candidate,—using human adenovirus vectors as opposed to Astra’s monkey vectors—lack of effective testing of this vaccine may result in compromised safety and efficacy when administered to large groups. What’s clear is: if issues develop related to lack of efficacy or safety of this vaccine, it could undermine public confidence in Operation Warp Speed’s vaccine candidate and other vaccines, resulting in further vaccine hesitancy. In effect, failure of Sputnik V could “poison” the entire field of vaccine candidates
Regarding the new Sputnik V vaccine, do its benefits outweigh its risks? At this time, we don’t know exactly how many people in Russia received it so far, but Russian elites or military involved in earlier trials are most likely the recipients of the new vaccine. The Russians, and their partners in Saudi Arabia and the United Arab Emirates (UAE), plan to produce 500 million doses of their vaccine, as they conduct essentially live Phase 3 trials on their vaccine, according to a report today by NBC News. It’s also vital to understand that a targeted global distribution of the vaccine could impact the Russians’ sphere of influence, which could certainly affect or change the optics of the upcoming election in November.
By: Robert Gladder, MD