Pfizer and its German partner BioNTech will be the first companies to seek authorization for a coronavirus vaccine in the United States. Human Services Secretary Alex Azar said this is a “light at the end of the tunnel.” The move means a vaccine could be available on a limited basis within weeks.
The companies said earlier this week that clinical trials showed it was 95% effective and well-tolerated in a 44,000-subject trial that included people over age 65—the population especially vulnerable to the virus.
Pfizer began manufacturing the vaccine when it was still in trials, and it now is on track to produce 50 million doses this year, enough to treat 25 million people with the two-dose regimen. If the FDA approval is swift, people—most likely health care workers and the most vulnerable—could start receiving the injections by mid-December.
The FDA is expected to move quickly given the urgent need. Companies have been working with the FDA throughout the development and trials as the Trump administration helped to expedite the process of safety investigation. This eight-month journey is truly remarkable and a model for clearing expensive, time-consuming, unnecessary bureaucratic hurdles to streamline the approval process without compromising safety.
Other Covid-19 treatments already have been approved, and more vaccines from other companies, especially Moderna, are expected to get the FDA nod soon.
The beauty of competition!
The vaccine success story is possible because the U.S. has a vibrant research-based pharmaceutical industry and an intellectual property system that protects the value of its investment in these life-saving medicines.
“Breakthroughs on vaccines and new treatments are finally offering the world a path to end the Covid-19 pandemic. They’re a tribute to private U.S. corporate innovation,” The Wall Street Journal opines today in “A Global Covid Vaccine Heist.” But India and South Africa are expected to ask the World Trade Organization today to allow them to violate U.S. patents and make these drugs themselves.
Intellectual property protection is the lifeblood of innovation; without it, the incentive to create new drugs would diminish and all the world’s population would be harmed by having fewer new and better drugs in the future. Companies have donated billions and billions of dollars in products to developing countries over decades and will find a path to getting vaccines to them as well.
Using the pandemic as a cover for theft is a terrible idea.
And speaking of bad ideas, President Trump is scheduled to announce this afternoon at the White House two rules aimed at lowering drug prices—including one we oppose that would peg the prices of certain prescription drugs in the U.S. to prices of the drugs in other developed countries.
Christopher Holt and Tara O’Neill Hayes of the American Action Forum (AAF) took a deep dive into “The Impact of a Most Favored Nation Drug Price Rulemaking on Innovation.” President Trump’s most favored nation (MFN) price proposal would require Medicare to pay no more for physician administered, outpatient drugs than the lowest price paid by any other country included in a list of economically comparable nations.
“Like the IPI proposal before it, the MFN rule is effectively the equivalent of importing foreign governments’ price control systems to the United States as a way to set prices for pharmaceuticals indirectly,” they write.
Based upon an earlier examination of this form of price controls on 26 drugs, AAF found that the MFN price controls would reduce drug company revenue by $12.8 billion annually, significantly reducing their budgets for research and development into new treatments and cures.
Galen Senior Fellow Doug Badger examined the impact on patients in other countries of the price controls in “Examination of International Drug Pricing Policies in Selected Countries Shows Prevalent Government Control over Pricing and Restrictions on Access.” He found that citizens of these countries have significantly less access to the newest drugs and their access can be delayed by years compared to U.S. residents who have access to virtually all the new drugs and much more quickly.
The president is expected to announce the MFN “Interim Final Rule” at the White House today as well as a separate measure we do support to assure that rebates provided by the drug companies to middle-men are instead passed along to consumers. Chris Holt provides an overview of both rules here.