FDA Says They Will Speed up Approval of New Covid Vaccines and Treatments
The Wall Street Journal is reporting that the FDA is laying new groundwork for the speedy approval of vaccines and treatments for the Omicron variant.
There are lots of treatments and vaccines in development that do not specifically target Omicron but may work on it regardless. This is because they don’t target the spike protein, the part of the Omicron virus with the highest number of mutations. So, we can expect the approval of these products to also be quicker if demand rises.
Vaccine companies are being told they don’t need to do any large or lengthy trials. Instead, the process would take about three months. Companies could run smaller trials with a few hundred subjects. Then the FDA would need at least two weeks to study the data and approve the vaccine. It’s possible that treatments could be approved even faster, especially if their toxicity profile is good.
A lot of people are talking about how Omicron cases seem mild. The mildness of cases outside of South Africa is likely due to the Traveller Effect. Inside South Africa, cases continue to rise. Numbers are climbing every day, and hospitalizations are being revised upwards.
Omicron appears to be highly transmissible and highly dangerous. Yesterday a pre-print was released showing that a previous Delta infection does not give you protection or immunity from Omicron. This is worrisome for the efficacy of vaccines since they both rely on antibodies.
If the vaccines don’t work as well or at all, then the current best treatment is still the early use of remdesivir which reduces hospitalization by 87%. If approved, Pfizer’s pill Pavloxid will knock out remdesivir as the best treatment option. But maybe not for long.
Yesterday at an Evercore conference, the Chief Medical Officer of Gilead said they are excited about their oral remdesivir program, and they hope to quickly move into human trials in 2022. (Fast-forward to 32:15)
So, if your company is working on a game-changing Covid-19 product, you might not have to wait a year to get it approved. If Omicron is as dangerous as some people think, then the demand for better vaccines and treatments will be astronomical.
Good luck out there and don’t forget to follow us on Twitter.
