A game-changer? Not so much in the US, but as EHE Heath CEO David Levy tells CNBC this morning, the news from AstraZeneca might be a game-changer for the rest of the world — if they want it to be. With its emergency-use authorization pending at the FDA, AstraZeneca released its data from Phase 3 trials in the US, showing a similar effectiveness level as the Johnson & Johnson/Janssen vaccine:
AstraZeneca’s COVID-19 vaccine provided strong protection against sickness and eliminated hospitalizations and deaths from the disease across all age groups in a late-stage study in the United States, the company announced Monday.
AstraZeneca said its experts did not identify any safety concerns related to the vaccine, including finding no increased risk of rare blood clots identified in Europe.
Although AstraZeneca’s vaccine has been authorized in more than 50 countries, it has not yet been given the green light in the U.S. — and has struggled to gain public trust amid a troubled rollout. The study comprised more than 30,000 volunteers, of whom two-thirds were given the vaccine while the rest got dummy shots.
In a statement, AstraZeneca said its COVID-19 vaccine was 79% effective at preventing symptomatic COVID-19 and was 100% effective in stopping severe disease and hospitalization, though it has not yet published full data. Investigators said the vaccine worked across all ages, including older people — something experts wanted better data on. Two doses of the AstraZeneca vaccine were given to people four weeks apart.
If the numbers hold up, this should warrant an EUA from the FDA later this month. These numbers make the impact very similar to the Johnson & Johnson vaccine, although J&J’s data was based on global trials and not just in the US. This lines up with the trajectory of the pandemic in places where AstraZeneca has been used as well, as vaccinations have been correlated with declines in cases, hospitalizations, and deaths.
This might have been a game changer in the US had the company been able to successfully complete its Phase 3 tests last year, as Levy told CNBC. It will add another dimension to US vaccination programs, but right now we appear to have already procured enough doses from the first three vaccines to inoculate everyone in this country, with plenty to spare:
Will this be a game-changer for the world? Yes, if AstraZeneca and the FDA can convince the world to take it. A number of countries have lost confidence in AstraZeneca, in part because of the false alarm on blood clots, but also because of AstraZeneca’s mistakes:
If the stakes hadn’t been so high, the AstraZeneca saga might have felt like a soap opera, with soaring moments of scientific brilliance undercut by embarrassing mistakes. The Oxford team that developed the vaccine was bold — but also appeared arrogant to many scientists on both sides of the Atlantic.
Had the rollout of the AstraZeneca vaccine been handled differently, it might have been available far more widely by now, blunting a new wave of death and disease that is threatening lives around the world. Countries that have administered it widely, such as Britain, credit AstraZeneca with helping drive a dramatic drop in hospitalizations and deaths. But public confidence in the company’s vaccine has taken a major hit, slowing its acceptance and delaying the battle against the pandemic.
Nowhere have the consequences been clearer than in Europe, which bet heavily on AstraZeneca vaccine doses but has received just a third of what was promised. Now, many countries are shutting down yet again as the more contagious coronavirus variant first spotted in Britain races across the continent. Hungary broke records for deaths and cases Friday. France imposed a strict new shutdown in much of the country. Germany’s cases were up 50 percent last week. And opinion polls suggest public willingness to get an AstraZeneca vaccine is dropping.
“AstraZeneca has unfortunately underproduced and underdelivered,” European Commission President Ursula von der Leyen told reporters last week. “And this painfully, of course, reduced the speed of the vaccination campaign.”
Read the whole report to recall the sequence of fumbles that put AstraZeneca well behind Pfizer, Moderna, and J&J. The US was fortunate, wise, or both to spread its bets across the board, but most of the rest of the world bet primarily on AstraZeneca (and then cheaped out on their bets to boot). Had AstraZeneca performed as well on its second US trial as it did on its first, many of these countries would be considerably farther along their inoculation curves, and likely would have less qualms about the vaccine as well.
If the FDA issues an EUA for this vaccine, it might help bolster global confidence in AstraZeneca again. We’d better hope it does, because the longer COVID percolates globally, the more risk we have in North America of lessening or eliminating our inoculated immunity.