The first vaccines for the COVID-19 pandemic may arrive in just shy of two months from today according to the World Health Organization (WHO) and several vaccine manufacturers.
Yesterday we reported on Indian Firm Bharat Biotech’s announcement claiming down to the day their vaccine will be ready on August 15 of this year. This news came just a few days after Indian rival Zydus Cadila’s news the company has entered human trials. This also came days after Bharat made a similar announcement. The Indian Council of Medical Reseach (ICMR) attempted to assuage concerns over its language of speeding up the vaccine saying its communications were meant to “cut unnecessary red tape” and “speed up recruitment of participants”.
In a letter from WHO chief scientist Soumya Swaminathan to The Hindu today, the expert’s outlook on the vaccine’s timeline was more subdued, stating, “A realistic (but very optimistic) timeline from the start of Phase-1 to the completion of Phase-3 could be about six to nine months (if all goes exactly according to plan).” Bharat’s announcement of approval for human trials puts its efforts at the start of the process, starting simultaneously in Phase I and II (not an uncommon practice in vaccine development).
Swaminathan assured the paper safety is still on the table: “Any vaccine must demonstrate efficacy and safety in a sizable number of participants. The WHO has published target product profiles for a COVID vaccine [and] immunogenicity data alone would be insufficient for a vaccine use policy. It is possible to have protocols which flow seamlessly from Phase-2 to Phase-3 based on interim analysis of data.”
The marketing language of speedy manufacturers like Bharat, Moderna, and AstraZeneca are often conflicting with the safety-centric language of the US CDC and the WHO.
“The pandemic demands unprecedented efforts to develop a vaccine.” Said Swaminathan, “That is why the WHO and partners launched the ACT (Access to COVID-19 Tools) accelerator to accelerate the development, deployment and delivery of COVID vaccines. While clinical trials need to be performed with scientific rigour and demonstrate efficacy and safety, timelines can be shortened by investing in manufacturing upfront, preparing sites in advance, regulatory harmonisation, collaboration between the different government agencies and anticipating the next steps. Performing trials in areas and among groups with a high risk of infection will also help by accumulating the necessary endpoints in a shorter time.”
Joining the aggressive August timeline is Oxford University, working with AstraZeneca. The partnership has several vaccines in late-stage trials as well as an ambitious supply chain strategy—the vaccine is already being produced ahead of test completion and approval to meet the partnership’s plans to release doses in the billions.
The worldwide race to create, test, and distribute a vaccine has some analysts concerned we may not have enough glass to hold them.
Oxford is looking to August as their soonest time for final approval of the vaccine, anticipating October availability if Emergency Use is granted. In some statements, AstraZeneca has shored in this estimate to as early as September 2020.
See our vaccine tracker where we track daily the status of every COVID-19 vaccine underway.
Also betting on expediting availability for October via Emergency Use authorization is Pfizer whom we contacted last Thursday. The company expects to deliver 100M doses and “potentially more than 1.2 billion doses by the end of 2021“. The company announced positive phase I/II results for their BNT162b1 vaccine earlier this week working with Biotech firm BioNTech.