INDIANAPOLIS (US) (BALBIR SINGH)

Drug manufacturers representatives from AstraZeneca, Johnson and Johnson, Merck, Moderna, and Pfizer.Daccine have expressed confidence to develop COVID-19 vaccine by either the end of 2020 or beginning of 2021. These representatives met this week members of the Energy and Commerce Committee. The members heard directly from representatives of five companies developing a COVID-19 vaccine at an Oversight and Investigations Subcommittee hearing entitled, “Pathway to a Vaccine: Efforts to Develop a Safe, Effective and Accessible COVID-19 Vaccine.”

The hearing examined the current state of research, development, and manufacturing of potential vaccines for COVID-19, according to information provided by Congresswoman Susan W Brooks.

Representatives from the companies provided a promising update on when a vaccine may be available. The development efforts for a COVID-19 vaccine are truly unprecedented and represent the exemplary work of pharmaceutical companies around the globe.

Each witness in the hearing expressed that the American public should take great confidence in the FDA’s guidance. The FDA’s safety and effectiveness standards are the result of years of rigorous research into infectious diseases and represent the gold standard world-wide.Right now, the companies are scaling up manufacturing “at risk”, by laying the groundwork to produce millions of doses of vaccines before they have proven the safety and effectiveness of the vaccine. If the vaccine is not proven to work, then the candidate won’t be brought to market. If, however, the vaccine candidate is successful they will have millions of doses ready to be distributed immediately upon approval.

“ Every witness expressed their intent to develop a safe and effective vaccine to combat this virus. Each company is on track to set a record-breaking pace for developing a vaccine by either the end of 2020 or beginning of 2021,” said Susan W. Brooks.

Each witness in the hearing expressed that the American public should take great confidence in the FDA’s guidance. The FDA’s safety and effectiveness standards are the result of years of rigorous research into infectious diseases and represent the gold standard world-wide.

Right now, the companies are scaling up manufacturing “at risk”, by laying the groundwork to produce millions of doses of vaccines before they have proven the safety and effectiveness of the vaccine. If the vaccine is not proven to work, then the candidate won’t be brought to market. If, however, the vaccine candidate is successful they will have millions of doses ready to be distributed immediately upon approval.

Just this week, HHS and DOD announced an agreement with Pfizer Inc. for large-scale production and nationwide delivery of 100 million doses of a COVID-19 vaccine in the U.S. following the vaccine’s successful manufacture and approval. The agreement also gives the U.S. government the option to acquire an additional 500 million doses, if needed, disclosed Congresswoman Susan W. Brooks.

The Federal Government is helping pharmaceutical companies bring COVID-19 vaccines to market. For example, last month the FDA released guidance for development of COVID-19 vaccines, which noted that companies need to run clinical trials large enough to demonstrate to the agency the safety and effectiveness of a vaccine. Further, the FDA set a minimum efficacy floor of 50%, meaning any vaccine candidate must be at least 50% effective in order to be brought to market. The agency may also require post marketing studies to further assess known or potential serious risks.

In addition to the FDA’s efforts, the U.S. Government is supporting several initiatives to help accelerate the development of vaccines for COVID-19. The Administration established Operation Warp Speed on May 15, 2020, to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. This public-private partnership aims to facilitate, at an unprecedented pace, the development, manufacturing, and distribution of COVID -19 countermeasures.

Each witness at the hearing this week spoke about building public trust with a vaccine by being transparent with the public, especially the communities who are disproportionately affected by the coronavirus. They are running clinical trials with a diverse set of participants, including individuals from a range of racial and ethnic backgrounds. For instance, AstraZeneca, a global bio and pharmaceutical company has committed to running clinical trials not just in the U.S., but also in the U.K, South Africa, and Brazil, to ensure the clinical trials represent folks from a diverse set of racial backgrounds. AstraZeneca’s development program will include a Phase III clinical trial with 30,000 participants and a pediatric trial, that will ensure the vaccine is safe for children.

For distribution of a COVID-19 vaccine, Operation Warp Speed is building the requisite plans and infrastructure to distribute it to hundreds of millions of Americans in a timely manner. Once a vaccine candidate is ready for distribution, the Department of Defense will help with logistics, while the CDC and Operation Warp Speed will make important decisions about allocation. This effort also includes reinforcing supply chains to ensure the US has enough distribution supplies including injection devices, glass vials, and syringes.

It is our hope that all the vaccine candidates work, though the government is casting a wide net to ensure that if any one or two candidates fail, we still have multiple back up alternatives.

It is my hope that once a COVID-19 vaccine is proven safe and effective, and is authorized by the FDA, Hoosiers will feel confident in getting a vaccine.

One item of concern for the House Energy and Commerce Committee is vaccine confidence in this country. A recent poll showed that as few as 50 percent of people in the U.S. are committed to receiving a vaccine, with another quarter wavering. This is alarming, given a safe and effective COVID-19 will save lives. It is even more concerning given that according to Johns Hopkins University, depending on how contagious an infection is, 70-90 percent of a population needs immunity to achieve herd immunity.