In an ongoing online hearing before the House Committee on Energy and Commerce’s Oversight and Investigation subcommittee, executives from across the pharmaceutical industry outlined the steps their companies are taking to combat COVID-19 and restore the world to a sense of normalcy.
In an ongoing online hearing before the House Committee on Energy and Commerce’s Oversight and Investigation subcommittee, executives from across the pharmaceutical industry outlined the steps their companies are taking to combat COVID-19 and restore the world to a sense of normalcy.
Not only were committee members concerned about whether or not a vaccine could be available by the end of the year, there were some concerns expressed that political pressure could push the U.S. Food and Drug Administration to lower its 50% efficacy threshold for potential approval of a vaccine – especially ahead of the November election.
Representatives from five companies developing COVID-19 vaccine candidates, Pfizer, AstraZeneca, Merck, Johnson & Johnson and Moderna, each said they were encouraged by early data that has been generated by their research teams and believe it is possible to deliver a safe and effective vaccine by the end of 2020 or early 2021.
As the virus continues to rage across the United States, committee Chairwoman Diana DeGette, D-Colo., said she was seeking brevity from the industry representatives regarding the likelihood of a potential vaccine.
Pfizer Chief Business Officer John Young said if the vaccine candidate under development by his company and Germany’s BioNTech continues to prove successful, his company could potentially seek approval from the U.S. Food and Drug Administration as early as October. He noted that Pfizer will spend about $1 billion of its own money on the development of the vaccine and has not accepted funding from the U.S. government. He added the company has begun to scale up production capabilities to manufacture the vaccine and bring it to the world, with an expected 100 million doses available by the end of the year.
“I am confident… science will win,” Young said.
Mene Pangalos, AstraZeneca’s head of BioPharmaceuticals R&D, said his company, which is partnered with the Jenner Institute of Oxford University on the development of a vaccine, pointed to early data released Monday that showed a robust response to the virus. If the Phase III program continues to demonstrate efficacy, he anticipated seeking regulatory approval by late fall with the potential to begin delivering doses to the public after that.
Three of the companies participating in this morning’s hearing recently posted positive Phase I data from their vaccine trials, with AstraZeneca being the most recent. Moderna and Pfizer, which is partnering with Germany’s BioNTech, both announced positive results last week. The three companies have advanced their vaccine programs into late-stage testing, all expected to begin by the end of July. Johnson & Johnson anticipates the launch of its clinical program for its vaccine candidate, Ad26.COV2-S, later this month. Merck has yet to launch its clinical programs. The company jumped into the vaccine development program with its May acquisition of Austria-based Themis, which has a pipeline of vaccine candidates and immune-modulatory therapies. Merck is also partnering with the nonprofit organization IAVI to develop a vaccine for COVID.
Lawmakers stressed they were cheering on all the companies in their development programs in order to combat the disease. That’s a sentiment shared by the pharmaceutical representatives.
“The race is on. Not against each other, but against this virus,” Julie Gerberding, Merck’s chief patent officer, told the committee during her testimony. She reminded the committee that researchers from across the industry are still learning about the virus, which was only discovered at the end of 2019.
Stephen Hoge, president of Moderna, recognized the devastating impact COVID-19 has had on the nation. That crushing impact is why it was so important for everyone to come together to develop a solution to the disease. Hoge said he was optimistic his company’s vaccine program will continue to demonstrate efficacy in a late-stage study and if it does hit the mark in Phase III, Moderna could begin delivering doses upon approval.
J&J’s Macaya Douoguih, head of Clinical Development and Medical Affairs at Janssen Vaccines, said her company is committed to provide 1 billion doses of a vaccine. The company has already forged manufacturing partnerships in order to meet that goal ahead of its clinical programs. J&J anticipates results from its Phase I/IIa trial in September and could go straight into a Phase III program should the vaccine prove effective. She reminded the committee members that J&J has committed to bringing a vaccine to the public at a not-for-profit price.
The pharmaceutical companies explained to the committee members that their trials have certain thresholds to meet before they can be called a success and submitted to the FDA for approval. Pangalos also reminded the members that their vaccine candidates will be submitted to other regulatory agencies across the globe and will have to meet the standards set by those organizations.
Pricing was also a concern raised by the committee members. The pharma representatives said they will ensure the vaccines will be affordable, with some selling the drug for a not-for-profit cost.
