COVID-19 Vaccine Development
- The National Institutes of Health, the Biomedical Advanced Research and Development Authority, pharmaceutical companies, and other federal agencies are working to expedite the safe and effective development of a vaccine for COVID-19.
- The Trump administration created Operation Warp Speed, with a goal of distributing hundreds of millions of vaccine doses to Americans by 2021.
- As vaccines are developed, the Food and Drug Administration has several ways to safely expedite the approval process to bring them to market.
Public health experts have stated that having an effective vaccine against COVID-19 will give people the confidence to fully reengage in society and revive the economy. The National Institutes of Health, Biomedical Advanced Research and Development Authority, Department of Defense, and other agencies are working with the pharmaceutical industry to safely speed the development of a vaccine for COVID-19. On May 15, the Trump administration announced the establishment of Operation Warp Speed. This program has received $10 billion from Congress to expedite the timeline for developing, manufacturing, and delivering a safe and effective vaccine by leveraging resources across the federal government.
Supporting vaccine Research and development
A public-private partnership is currently working to prioritize and coordinate efforts to develop the most promising treatments and vaccines. The NIH-led initiative, called Accelerating COVID-19 Therapeutic Interventions and Vaccines, includes the Departments of Health and Human Services, Defense, and Veterans Affairs; the European Medicines Agency; vaccine developers; and other private and public organizations. It has four focus areas that will establish a common framework for: evaluating preclinical candidates; identifying potential trial participants; conducting clinical trials; and helping to compare safety and efficacy data for multiple products. Partners in ACTIV also will try to identify how the virus affects certain groups of people, especially those who are at high risk for serious outcomes associated with COVID-19. According to NIH Director Francis Collins, “Working together so each potential vaccine is tested the same way instead of each company devising its own methods will further speed answers and allow accurate comparisons.”
A separate initiative, Operation Warp Speed, aims to develop and manufacture at least 300 million vaccine doses by next January. As part of this effort, BARDA awarded $628 million to Emergent BioSolutions to enhance vaccine manufacturing capacity. BARDA also recently awarded a $204 million contract for glass vials for the eventual vaccine and to support the availability of necessary ancillary supplies for its delivery and administration.
expediting VACCINE Availability
The Trump administration has selected vaccine candidates from five pharmaceutical companies for Operation Warp Speed as potential candidates for producing a viable COVID-19 vaccine: Moderna Therapeutics; AstraZeneca; Johnson & Johnson; Merck; and Pfizer. Johnson & Johnson expects to begin human trials of its vaccine in July with a joint phase 1 and phase 2 trial to evaluate the safety of the vaccine and measure whether the vaccine triggers an immune response, which is an early indicator that the vaccine may be effective in people. Moderna’s vaccine candidate is currently in phase 2 studies and may be the first of the five candidates to enter phase 3 human trials later this summer.
Ways FDA Can Expedite the Vaccine Development and Review Process
Source: Congressional Research Service
Drug makers are streamlining their development processes by leveraging studies in animal models, accelerating the pace of clinical trials, and starting to manufacture the product while it continues to move through late-stage clinical development. BARDA plays a critical role in contracting with specific vaccine manufacturing companies and other industry partners to start the manufacturing process early, reserve space for hundreds of millions of doses, and invest in the production of vials, syringes, and other items that will be critical to administer the vaccine. Regardless of how fast this process moves, the FDA will still need to certify that the vaccine is safe and effective before it receives an “emergency use authorization” to market the product. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has noted that speeding up the vaccine development process poses more of a financial risk to drug manufacturer than a safety risk to patients, because a product may be manufactured at scale, but ultimately may not demonstrate efficacy sufficiently, and those doses that were manufactured will go unused.
After these steps are completed, the Centers for Disease Control and Prevention will lead the effort to distribute the vaccine to the American people as quickly and fairly as possible. This effort will be critical to make sure all of the funding and research efforts on the front end pay dividends by helping the American people receive a vaccine and are protected from the coronavirus.
safely Expediting the FDA REVIEW process
Introducing biologics, such as vaccines, into the market typically requires approval by the Food and Drug Administration. The FDA is charged with ensuring the product is safe and effective, and its review process can be long and complex. However, the agency has statutory authorities that allow it to expedite its processes under certain conditions by prioritizing certain products for review or providing scientific flexibility in how it evaluates products, while maintaining the safety and effectiveness standards. The Coronavirus Preparedness and Response Supplemental Appropriation Act gave the FDA $61 million for coronavirus preparation and response, including for vaccine and countermeasure development. These resources will help the FDA review products intended for use against COVID-19.
In terms of shifting how the evaluation processes is done, the Food, Drug, and Cosmetic Act offers the FDA several ways to expedite the development and review process for biologics. For example, a drug can receive a fast track review, which means the FDA facilitates the development and expedites the review of that drug if the agency determines that there are no other treatment options available. This can shorten the time frame for reviewing an application by several months. Current law also allows the FDA to designate a drug as a “breakthrough therapy” if it demonstrates significant improvement over other therapies. The agency can grant “accelerated approval” to a drug for a serious condition and that meets an unmet medical need based on evidence of safety and an efficacy using a surrogate endpoint. This allows FDA to review and approve a drug without having to wait for data demonstrating clinical benefit, which may take years to determine. FDA also may grant priority review for drugs that provide significant improvements, either in terms of safety or effectiveness, over existing treatments. Typically, the agency aims to take action on drugs that have received priority review within six months, versus 10 months for the typical review process.
The law also allows the FDA during a declared public health emergency to authorize the use of a drug either before it has received approval or for an unapproved use of an approved drug. This is known as an emergency use authorization. When an EUA is issued, FDA outlines the circumstances under which the drug is authorized to be used. The EUA is based on a determination that the benefits of using the product are likely to outweigh its risks because of the needs created by the emergency.
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