By Riley Griffin
Drug companies are beginning to unveil medical advances in the battle against coronavirus, in what one CEO described as “an incredible feat of disease science.” Over the next several weeks, we are likely to learn a lot more about how well these vaccines and treatments work.
In a one-two-pandemic hit on Nov.9, Pfizer Inc. and BioNTech SE reported that their vaccine was highly effective in preventing symptomatic cases of Covid-19, while Eli Lilly & Co.’s treatment for those in the early stages received a green light from US regulators.
Read | India has launched an integrated response against the Covid-19 pandemic: Vardhan
While optimism helped counter reports of the virus’ resurgence around the world, questions remain about the safety, efficacy, and durability of emerging vaccines and treatments, as well as who they help most. And as drug manufacturers prepare to receive emergency use authorizations from the U.S. Food and Drug Administration and other regulators around the world, they are also addressing manufacturing-related hurdles, continuing to negotiate supply agreements with governments and determining how to get the product out of their facilities and into hospitals, clinics, pharmacies and outpatient facilities such as nursing homes.
There are a lot of rapid developments to keep track of, so here’s what you need to know for the next few weeks.
What should Pfizer and BioNTech do before approaching regulators?
The two companies reported the initial analysis in a press release, not in a peer-reviewed medical journal. That means more comprehensive data is needed to show how well the two-dose vaccine regimen works in the elderly and other vulnerable groups. The analysis also did not include any severe cases of Covid-19, which is necessary to show how well it works to prevent the deadliest form of the disease.
Read also | Trust in vaccines vital to stopping coronavirus: WHO
In order to approach US regulators, Pfizer and BioNTech must also report safety data to obtain an emergency use authorization. The companies anticipate that they will have accumulated the two months of safety data requested by the FDA for the people in the trial by next week. If there are no unforeseen problems, the New York-based drug giant and its German partner could apply for authorization soon after, potentially even this month.
What happens after companies have applied for an emergency authorization in the US?
Then come the authorities. US regulators and outside experts will evaluate the data and hold a hearing aimed at increasing public confidence. (This is key because only half of American adults say they are likely to receive the Covid-19 vaccine.) And, if approval is finally granted, more outside experts convened by the Centers for Disease Control and Prevention will step in to decide who should get the vaccine first.
Health and Human Services Secretary Alex Azar said last week that distribution in the United States could begin in increments of 20 million doses per month as early as the end of November. And while the vaccines will be pre-placed in locations across the country in anticipation of a clearance, health experts don’t expect a vaccination campaign to begin until December or early January. And in the meantime, health departments must overcome a major hurdle: Injections must be stored at -94 ° F, a temperature that normal freezers cannot withstand.
What other vaccine manufacturers could soon follow up with their own data?
Like Pfizer and BioNTech, Moderna Inc. is working on a vaccine that uses so-called messenger RNA. The fact that it uses the same technology bodes well for Moderna, which is only slightly behind its peers. A recent explosion of cases in the US is helping accelerate biotechnology’s late-stage clinical trial. He has accumulated more than 53 infections, which means that an independent monitoring committee will carry out a preliminary analysis of the effectiveness of the injection in a few days. Top infectious disease specialists, including Anthony Fauci, hope it will be as successful as the Pfizer injection in preventing symptomatic infections.
Meanwhile, AstraZeneca Plc and the University of Oxford are expected to report preliminary data from their advanced trials in the coming weeks. Its vaccine is already under accelerated review in the United Kingdom and the European Union, with the hope that it may be available for large-scale deployment by the end of the year.
Johnson & Johnson is further behind. So far, it has only enrolled a few thousand participants in its 60,000-person trial. That’s partly because he lost two weeks when recruiting was halted due to a security issue. Although the trial resumed in late October, J&J now expects to have an initial reading of the trial results early next year, rather than late 2020. Data experts from UnitedHealth Group Inc. are being tapped to accelerate the recruitment
Read also | Serum Institute awaits the emergency authorization of the Covid-19 vaccine for December
Novavax Inc. is preparing to launch a large late-stage US trial before the end of the month, while Sanofi and its partner GlaxoSmithKline Plc, two of the world’s largest vaccine manufacturers, and German pharmaceutical company CureVac NV , are looking to start advanced testing of their candidates at the end of the year.
What’s next for antibody therapies like Eli Lilly’s?
Lilly’s emergency use authorization expands access to a new tool to fight the virus in high-risk patients before they are sick enough to require hospitalization. These kinds of monoclonal antibody therapies, as well as antivirals, are necessary for people to be able to receive treatment early on, thus avoiding overcrowded health systems, Fauci said Thursday.
Lilly CEO David Ricks told Bloomberg that the biggest challenge ahead will be meeting an increase in demand with limited supply. “We’re going to run out,” he said.
Another drug maker, Regeneron Pharmaceuticals Inc., is nearing the finish line and could bolster the offering. The Tarrytown, New York-based pharmaceutical company became the center of attention when President Donald Trump received his cocktail of experimental antibodies in early October when he was ill with the virus. In a few days, Regeneron could learn from US regulators if his therapy has received authorization.
.
