Major vaccine brands hope that one or more vaccines can be had from 2021 and that at least two promised doses will be lost or affordable to all Americans.
Speaking before a House subcommittee on Tuesday, AstraZeneca, Johnson-Johnson, Merck, Moderna and Pfizer executives said their purpose was to have effective vaccines as soon as possible while following all protection and regulation guidelines.
None of the pharmaceutical executives would prepare a vaccine for the general public by the beginning of 2021, despite repeated questions from Members of the House.
The United States has invested approximately $2.3 billion in the effort to locate a vaccine to prevent SARS-CoV-2, the virus that causes COVID-19, which has killed more than 140,000 Americans.
Security has a major fear among lawmakers, and several leaders wonder whether the unprecedented speed of vaccine progression or potentially lax government regulations would put the public at risk. All the panellists stated that protection would not be compromised.
The Food and Drug Administration released extensive guidance covering what would be necessary for a vaccine to be approved on June 30. One of the requirements was that any vaccine be at least 50% effective at preventing COVID-19 infections.
None of AstraZeneca’s interactions with regulators indicated that there was a reduction in standards, executive vice president Menelas Pangalos said.
Dr. Julie Gerberding, Merck’s executive vice president and chief patient officer, said the company was “relieved” that the FDA insisted on applying the same protection restrictions that apply to all vaccines.
Dr. Macaya Douoguih, Johnson and Johnson’s head of clinical progression and medical affairs, hypothetically advised that if FDA rules were replaced to require only 10% efficacy, Johnson and Johnson would publish their vaccine.
“We would be comfortable providing a product that would be effective according to our protocol,” he said.
Pricing was another question raised by several House members.
Pangalos of AstraZeneca stated that the company would sell at cost, as would Johnson and Johnson’s Douoguih.
The other three corporations said they’d do that.
“We probably wouldn’t sell it at cost, no ma’am,” said Moderna’s president, Dr. Stephen Hoge.
Merck’s Gerberding said, “No, we’ll sell a vaccine at cost.”
Pfizer’s chief business officer John Young would not commit to providing vaccine at cost, but said, “We recognize that these are extraordinary times and our pricing will reflect that during the pandemic.”
Company leaders also provided updates on their ongoing vaccine efforts:
AstraZeneca will make two billion doses of its vaccine on a non-profit basis, Pangalos told lawmakers. The company, which is creating a vaccine in conjunction with the United Kingdom’s University of Oxford, said Monday it hopes to have a vaccine available by early next year.
The company’s candidate vaccine is recently in Phase 2 clinical trials in the preclinical examination of knowledge and tested in more than 1,000 volunteers.
“We are making immediate progress in these clinical systems in the hope that the effects of our complex trials, which are lately planned to involve about 50,000 volunteers together, will be held this fall,” Pangalos said.
The Anglo-Swedish company has agreements with the United States and several other countries and organizations to supply vaccines.
The United States paid $1.2 billion to access three hundred million doses of the candidate vaccine through Operation Warp Speed, a White House working group that aims to bring coronavirus treatments and vaccines to market as soon as it is safely conceivable.
An article published on Monday gave hope for the overall good fortune of vaccines imaginable. The effects showed that the Oxford vaccine candidate, AZD-1222, led to strong immune responses for just two months in a trial that continues with more than 1,000 healthy adults.
Pangalos said his company plans to supply approximately two billion doses globally to provide “broad and equitable access.” The company is building parallel supply chains around the world to produce those doses, he said.
In addition: the candidate for the coronavirus vaccine at the University of Oxford in the UK is effective with few effects, according to the first results of the trials.
Read more: How much does a COVID-19 vaccine cost? Should all Americans get vaccinated for free?
Johnson-Johnson will rate the overall value of your vaccine, regardless of country or source of income level, Douoguih said.
He plans to make at least 400,000 doses of his candidate vaccine in the United States, he said.
The company is committed to making a COVID-19 vaccine affordable to have on “a non-profit base for use in an emergency pandemic,” he said. It will continue with external validation for value calculation and provide an external audit or certification.
The company earned approximately $500 million from Operation Warp Speed for its work.
Johnson-Johnson plans his human candidate vaccine at the end of the month in the United States and Belgium. If the initial effects are positive, it will launch a global phase 3 clinical trial in September.
Phase 3 trials are the final and largest testing stage for vaccines once they have become established, don’t cause immediate adverse effects and provoke an immune response. COVID-19 Phase 3 trials will involve 30,000 patients for each vaccine candidate and take many months.
US pharmaceutical company Merck is looking for two vaccine candidates imaginable. He focuses on his long delight in vaccine progression and the need for safety, and was open-minded about the option that no breakthrough would be made.
“If approaches evolved through others in the end are incredible for those persecuted through Merck, we will make paintings to help those efforts to gain the benefits of the global fitness of the pandemic,” Gerberding said.
Merck holds the record for the creation of the fastest vaccine ever released, a mumps vaccine in 1967 that took 4 years from start to finish. But the company has continually targeted the protection that at the speed in its paints on the COVID-19.
“Speed is important, but we will not compromise scientific efficacy, quality, and above all, safety, despite the sense of urgency we all feel,” said Gerberding in testimony provided to the committee.
The company’s CEO, Kenneth Fraizer, said on June 30 that a vaccine might not be rushed and rigorous science is needed.
“When other people tell the public that there will be a vaccine until the late 2020s, for example, I think they are doing a very bad service to the public,” he said in an interview with Harvard Business School.
Merck earned $38 million for the U.S. Advanced Biomedical Research and Development Authority, BARDA vaccine.
Moderna has entered into agreements with a Swiss-based vaccine manufacturer with sites in the United States and around the world, which will allow it to succeed in an annual production capacity of more than 500 million doses, said the company’s president, Dr. Stephen Hoge. .
His studies on candidate vaccines in part provided through $536 million from Operation Warp Speed.
Modern, based in Massachusetts, hopes to begin phase 3 clinical trials with its vaccine candidate this month, Hoge said.
The effects of Phase 1 were presented last week. The vaccine results and causes an immune reaction. According to several experts who have reviewed the effects, it is not known whether the immune reaction is sufficient to protect someone from the coronavirus that causes COVID-19.
The company has already recruited six hundred volunteers in its Phase 2 studies, Hoge said.
Only among the five corporations evaluated on Tuesday, Pfizer received no cash from the U.S. government, as it works with 4 other COVID-19 vaccine applicants.
“We are uniquely positioned with clinical experience and experience, production scale and monetary resources to be able to provide possible federal funding for the vaccine,” said John Young, Pfizer’s chief advertising officer, in a statement.
He projected that the company would invest about $1 billion in its vaccine progression efforts by 2020.
Pfizer is partnering with German biotechnology company BioNTech to paint a COVID-19 vaccine. He has been conducting early clinical trials in the United States and the European Union lately.
Last week, he announced that two of his four candidate vaccines had gained an accelerated DESIGNATION from the FDA. Expect to begin phase 2 testing by the end of this month.
The company believes it may file an application with the FDA in October, Young said.
If clinical trials progress well, the company expects to manufacture up to one hundred million doses by the end of 2020, and potentially more than 1.3 billion doses worldwide, Young said.
“I am sure that our industry will triumph over the last final results of our war opposed to COVID-19, and that science will triumph,” he said.
Contributing: Karen Weintraub