WASHINGTON (CN) — As the number of confirmed U.S. cases of Covid-19 neared 4 million on Wednesday, the Trump administration announced an almost $2 billion vaccine contract with the New York-based pharmaceutical giant Pfizer and a German biotechnology company.
According to a statement released by the U.S. Department of Health and Human Services, the Department of Defense will pay Pfizer and BioNTech $1.95 billion upon the receipt of the first 100 million doses, which would need to be approved by the Food and Drug Administration before distribution. After the first round of vaccines, the federal government will have the option to order an additional 500 million doses, according to the contract. The United States has set a goal to have 300 million doses of a safe and effective vaccine by December 2020.
“Through Operation Warp Speed, we are assembling a portfolio of vaccines to increase the odds that the American people will have at least one safe, effective vaccine as soon as the end of this year,” HHS Secretary Alex Azar said in the statement. “Depending on success in clinical trials, today’s agreement will enable the delivery of approximately 100 million doses of vaccine being developed by Pfizer and BioNTech.”
This contract marks the campaign’s largest agreement to date.
Pfizer and BioNTech noted in a joint statement Wednesday that Americans would receive the vaccines for free, “consistent with U.S. government’s commitment for free access for Covid-19 vaccines.” The companies are working on a vaccine that utilizes messenger RNA, or mRNA, extracted from the virus — a technology that has never before been utilized in an approved vaccine but one in which BioNTech says it has “deep expertise,” according to the companies’ press release. The mRNA vaccines could take less time to develop than conventional vaccines.
Explaining this in an interview, biology professor Anna Yeung-Cheung at Manhattanville College noted that conventionally there’s a period of time where researchers have to grow viruses for the vaccines. But with mRNA vaccines, they can instead replicate the viruses’ mRNA sequences quickly with machines. The technology dates back at least 30 years, she said. As she explained it, a Covid-19 mRNA sequence would be inserted into a human body whose immune system would recognize the sequence as a foreign body.
Lee Riley, a professor of epidemiology at the University of California, Berkeley, says that another major advantage of nucleic-acid-based vaccines is that they can induce both antibody and cell-mediated immune responses, a combination that may lead to protections against different strains of a virus.
“A lot of work has been done on DNA vaccines, especially for veterinary work, and some such vaccines have been approved,” he said, citing the example of a vaccine used to protect horses from West Nile disease.
The same approach has been used to make RNA vaccines for RNA virus infections, including influenza. Riley noted that mouse models for this approach have shown early promise but that mRNA vaccines have not yet been shown to induce high-level antibody titers in large animal trials or in human volunteers.
“The recent result with the Moderna RNA vaccine against SARS-CoV2 is very promising, as it induced high levels of antibody response,” he said, adding that these vaccines have been shown to be, in general, safe.
Safety and efficacy trials for the Pfizer-BioNTech vaccine will be underway this month. The FDA in July announced new guidance mandating randomized, placebo-controlled tests and stipulated specifically that effectiveness levels must prevent Covid-19 from forming in at least 50% of those taking the drug before hitting the market. Drugs triggering the body to generate antibodies alone are also not considered sufficient.
Riley said the length of time it typically takes for a vaccine to work its way through clinical trials varies.
“We still don’t have an AIDS vaccine, after more than 30 years of work,” he said, noting that with Covid-19, the preclinical research phase was fast-tracked thanks to early work on the first SARS coronavirus (SARS-CoV-1) and the MERS coronavirus.
“Normally, a phase I trial could take about a year,” he said, referring to the phase designed to look for adverse vaccine effects.
“Phase II [which looks for vaccine adverse events as well as immunological responses to the vaccine indicative of its potential protective ability] perhaps about the same or a bit longer,” Riley added. “Phase III [another look at safety or effectiveness] could take longer, depending on how quickly they can recruit volunteers. Phase IV evaluation is also done post-licensing to look for rarer adverse events that may not have been identified during the early phase trials.”
Through Operation Warp Speed, the U.S. government has also committed funding to AstraZeneca, Johnson & Johnson, Novavax and Moderna. Moderna is also using mRNA technology.
Pfizer’s refusal to take federal funds upfront for vaccine research came under congressional scrutiny Tuesday, with lawmakers warning it could lead to price-gouging.
“We didn’t accept the federal government funding solely for the reason that we wanted to be able to move as quickly as possible with our vaccine candidate into the clinic,” John Young, Pfizer’s chief business officer, testified.
Bills such as the Make Medications Affordable by Preventing Pandemic Pricegouging Act (MMAPPP) Act of 2020, sponsored by Illinois Representative Jan Schakowsky, and the Taxpayer Research and Coronavirus Knowledge (TRACK) Act, sponsored by Texas Representative Lloyd Doggett were released Monday morning aiming to prevent drug price gouging of Covid-19 treatments.
One more thing to consider is that while some vaccines, like the chickenpox vaccine, last a lifetime, Yeung-Cheung noted that we don’t know the lifespan of Covid-19 antibodies.
“There is no finalized research that says these antibodies last forever,” she continued. “Even with people naturally infected with the viruses, the data hasn’t shown the antibodies give them lifetime protection.”
Yeung-Cheung called it possible a new Covid-19 vaccine would need to be manufactured annually.