STAT News has an excellent article evaluating where we are on the federal initiative to fast track the development of treatments and vaccines for COVID-19.
To date, the fastest a vaccine was ever developed was four years. Operation Warp Speed, or OWS, has already spent about $10 billion to help vaccine makers develop their candidates and build out production capacity to make vaccines at commercial scale. An innovation of this process: The vaccine makers are already producing doses, before they even know if the vaccines work. The idea is that if a vaccine is shown to be protective, use of it can start immediately. Moncef Slaoui, the scientific head of OWS, told STAT last week that the initiative has already started to stockpile upward of hundreds of thousands of doses.
Operation Warp Speed’s impact on therapeutics to treat patients who already have COVID-19 has been more modest.
The initiative has made only one major investment in manufacturing: a $450 million payment to Regeneron to build up manufacturing for its monoclonal antibody treatment, which is still in clinical trials. OWS has also provided support to studies of a similar medicine being developed by Eli Lilly. It’s hoped that the antibodies will be able to be used both for treatment and prevention of Covid-19, but experts still worry about whether pharmaceutical companies can make enough of these treatments should they prove effective.
A major government-run study begun before OWS was involved showed that remdesivir, a drug developed by Gilead Sciences, shortened the time it took for patients to recover from Covid-19 by four days. This moderate effect is still the best seen by a new drug for Covid. A much older treatment — the steroid dexamethasone — was shown to have a big benefit late in Covid-19 by a study funded not by the United States but by the United Kingdom.
While manufacturing capacity is rising, we also have to worry about more mundane supplies: glass vials to transport the vaccines and syringes to administer them. There are also issues of distribution and including appropriate cold chain quality control. For instance, Pfizer’s vaccine must be stored at at -70 degrees Celsius; thus distribution is a non-trivial issue here.
Operation Warp Speed had spent a lot of money but also provided the potential to create and distribute vaccines to millions of Americans. If it produces a safe and effective vaccine, OWS could be one of the greatest policy decisions of our time; if it fails, it could result in a significant waste of resources. Nevertheless, given the scope of the COVID pandemic, it’s something we need to try for the health, safety and sanity of all Americans.