Chalk up another Operation Warp Speed reveal, thanks to corporate reporting. Moderna has one of the three most promising and advanced COVID-19 vaccine candidates, which is currently in Phase 3 testing. Following a similar announcement from Pfizer earlier this week, Moderna told its investors that they have begun “actively preparing for the launch of mRNA-1273,” and that they may join Pfizer in a late-November emergency-use application in the US:
“We are actively preparing for the launch of mRNA-1273 and we have signed a number of supply agreements with governments around the world,” Moderna CEO Stephane Bancel said in a press release. “Moderna is committed to the highest data quality standards and rigorous scientific research as we continue to work with regulators to advance mRNA-1273.”
Shares of Moderna were up more than 3% in midmorning trading.
Moderna, a front-runner in the Covid-19 vaccine race, said last week it had completed enrollment for its 30,000-participant late-stage trial. As of last week, more than 25,650 participants had received the second of the company’s two-dose Covid-19 vaccine. Moderna said about 37% of the participants were from diverse communities and 42% were at high risk of severe disease. …
On a call with investors Thursday, Bancel said the company expects the data and safety monitoring board, which will assess whether the trial is successful, will conduct its first interim analysis in November. The board will not conduct its analysis until after there are 53 cases of Covid-19 diagnosed in Moderna’s phase three trial.
Forbes notes that Moderna appears to be slightly behind Pfizer, but it’s not by much:
Last week, the company said that it completed the enrollment process of 30,000 participants in its final-stage study, with initial data on the efficacy of the vaccine expected by late November. The company will apply for emergency-use authorization – which could cover use for high-risk individuals such as the elderly and healthcare workers – around December, at the earliest.
While the clinical trials continue to progress, Moderna and its manufacturing partners are doubling down on production with plans to produce 20 million doses of the vaccine by the end of the year. Assuming that two doses are required, this would be enough for about 10 million people. The company intends to manufacture at least 500 million to 1 billion doses in 2021. …
That said, Moderna appears to be slightly behind Pfizer’s (NYSE:PFE) vaccine candidate, which is being developed with German biotech BioNTech (BNTX). Pfizer PFE -0.9% is likely to provide efficacy data on its vaccine as early as this month and there is a possibility that it could receive emergency approval before the end of this year. Pfizer expects to have about 100 million doses available by year-end.
Pfizer has already produced twice as many double doses and is closer to the emergency-use authorization request. Thanks to the funding from Operation Warp Speed and the newer COVAX initiative, Pfizer has gotten farther down the production curve, as Forbes points out. However, its vaccine requires much colder storage, which will complicate distribution and access at least a little bit. Either way, it appears that tens of millions of doses of these two vaccines may be accessible before Christmas — which would create a large impact on the ability to curtail transmission of COVID-19.
There is even more good news on a non-vaccine front. The Regeneron cocktail that Donald Trump took looks like it will become an effective way to address acute cases in general, and higher-risk patients especially:
Regeneron Pharmaceuticals said Wednesday its coronavirus antibody cocktail, the experimental treatment that President Donald Trump received, significantly reduced medical visits in a trial of nearly 800 patients with mild-to-moderate Covid-19.
Regeneron said patients given the treatment, REGN-COV2, made around 57 percent fewer Covid-19-related medical visits than those given a placebo over a 29-day period.
The drop was around 72 percent in patients with one or more risk factors, such as being over age 50, obesity, cardiovascular, metabolic, lung, liver or kidney disease, or an immunocompromised status.
Last month, the company released early data from the trial showing the treatment reduced viral levels and improved symptoms in non-hospitalized Covid-19 patients. The new data confirm the initial findings, the company said.
Regeneron has 50,000 doses already on hand; Operation Warp Speed paid for 300,000 doses, so production should ramp up quickly now. The FDA already has an emergency-use authorization request in hand from Regeneron and are reviewing the data. If it passes muster, it comes just in time to address a national increase in hospitalizations and diagnoses. Hopefully Regeneron can escalate its production quickly.
People are understandably impatient for these developments, perhaps none more than Trump himself. These are lights at the end of a tunnel — although a very long tunnel still. We should not forget to consider just how extraordinary this fast innovation has been — and if it succeeds, just how well Operation Warp Speed performed.
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