Loyola University School of Law, JD 2021
Recently, the U.S. Food & Drug Administration (“FDA”) announced a scheduled meeting of its Vaccines and Related Biological Products Advisory Committee (“VRBPAC”) to discuss the request for emergency use authorization (“EUA”) for a COVID-19 vaccine from Janssen Biotech Inc. The FDA has just under three weeks to complete its report before the VRBPAC’s meeting to make its recommendation on the vaccine. The review process may be more challenging than the past two reviews for Pfizer and Moderna due to the composition differences and effectiveness.
History of Johnson & Johnson
Jansen Biotech Inc. is a pharmaceutical company owned by Johnson & Johnson and has officially requested the FDA for emergency use authorization of its COVID-19 vaccine. For over 130 years, the company has operated under the belief that good health is the foundation of vibrant lives, thriving communities and forward progress and is now one of the world’s largest and most broadly based healthcare company. Johnson & Johnson has an unwavering commitment to equitable global access to the medicines and innovations being developed to fight the COVID-19 pandemic. With this plan, they will bring forward a safe, effective, and affordable vaccine on a not-for-profit basis for emergency pandemic use.
The company in the past has been one of the leading healthcare companies to develop and distribute vaccines for Ebola, Tuberculosis, and other viruses. In 2020, Johnson & Johnson pledged to allocate up to 500 million doses of its investigational COVID-19 vaccine candidate, if it is proven to be safe and effective, to lower income countries. If authorized by the FDA, the vaccine in the United States may be available as early as March. The Johnson & Johnson vaccine would also be the third approved by the FDA.
The Janssen COVID-19 vaccine
Unlike the other COVID-19 vaccines currently authorized by the FDA, the Janssen COVID-19 vaccine is a single dose vaccine. The Phase 3 ENSEMBLE study showed the amount of protection against moderate to severe COVID-19 infection was 72% in the United States, 66% in Latin America and 57% in South Africa twenty-eight days after vaccination. The vaccine was 85% effective in preventing severe disease across all regions studied. Twenty-eight days after the vaccination, the vaccine demonstrated complete protection against COVID-related hospitalization and death.
Another difference between the Johnson & Johnson vaccine and other FDA authorized vaccines is the storage capabilities. This vaccine can be stored in a standard refrigerator for up to three months while the other vaccines must be stored at super-cold temperatures. The US government has already ordered 100 million doses and Johnson & Johnson says it will meet this commitment by June.
Now that Johnson & Johnson has requested emergency use authorization, the FDA will begin its review of all the data submitted by Johnson & Johnson and create a report to submit to the FDA’s independent vaccine advisory committee. The committee will then meet on February 26 to evaluate the report and decide if they believe the FDA should authorize the vaccine. To keep the public informed, the FDA intends to make background materials available including the meeting agenda and committee roster, no later than two business days prior to the meeting. Everyone will have an opportunity to view the meeting via livestream on Facebook, YouTube, and Twitter channels as well as a webcast on the FDA’s site. The members of the VRBPAC are independent scientific and public health experts who provide advice to the FDA, which may include advice on the safety and effectiveness data submitted in the EUA request. The decision made by the committee is not binding and all final decisions on whether to authorize the vaccine for emergency use are made by the FDA’s professional staff. Although the decision made by the VRBPAC is not binding, their advice and input lends credibility to regulatory decisions made and helps those decisions stand up to intense public scrutiny.
FDA authorization versus approval
While some may use the term “authorize” and “approve” interchangeably, the FDA has different processes for both. None of the COVID-19 vaccines have been approved but have all been authorized for emergency use. Approval of a product by the FDA means the agency has deemed the product to be safe and effective for its designated use. More recently, the FDA has streamlined its review process for medical products to help speed important new treatments to patients. The average review time for an innovative new drug is now only 6 months while some have been approved even faster.
For the COVID-19 vaccines, the FDA has used the emergency use authorization procedure to speed up the process. Under this process, the FDA may allow the use of unapproved medical products in an emergency to diagnose, treat, or prevent life-threatening diseases or conditions when certain statutory criteria have been met. Under Section 564(c)(2) of the Food, Drug, and Cosmetic Act, some of the statutory requirements includes whether there are no adequate, approved, and available alternatives and the known and potential benefits outweigh the known and potential risks of the product. Once a company submits an emergency use authorization request to the FDA, it will determine whether the relevant statutory criteria are met. Despite the expedited process, clinical trials are being conducted according to the rigorous standards set forth by the FDA. With the urgent need for safe and effective vaccines, the FDA is utilizing its various authorities and expertise to facilitate the quick development and availability of vaccines that have met the agency’s rigorous and science-based standards for quality, safety, and effectiveness.