Merck & Co – known as MSD outside the US and Canada – has signed multiple agreements to expand manufacturing capacity supply of COVID-19 vaccines, including Johnson & Johnson’s (J&J) jab.
The US Department of Health and Human Services’ (HHS) Biomedical Advanced Research and Development Authority (BARDA) will provide Merck & Co with up to $268.8m to adapt and make available a number of the company’s existing manufacturing facilities for the production of COVID-19 vaccines and medicines.
In addition, Merck & Co has also entered an agreement with J&J’s Janssen Pharmaceuticals company to support manufacturing and supply of its COVID-19 vaccine.
In a statement, Merck & Co said that it will use its facilities in the US to produce drug substance, formulate and fill vials of J&J’s COVID-19 vaccine.
J&J’s phase 3 ENSEMBLE trial found that the vaccine was 66% effective overall in preventing moderate-to-severe COVID-19, 28 days after vaccination.
In the US, the efficacy rate was 72% while in Latin America and South Africa the vaccine was 66% and 57% effective, respectively.
In South Africa, J&J said that 95% of the COVID-19 cases observed in the study were caused by the recently discovered B.1.351 virus variant.
Although the vaccine is less effective against the B.1.351 variant that was first discovered in South Africa, J&J said that the jab was 85% effective in preventing severe disease across all regions studied.
Importantly, the one-dose vaccine could be rolled out with more ease and efficiency compared to other two-dose regimens.
“At Merck, we have a rich legacy in vaccine manufacturing and look forward to combining our expertise with Johnson & Johnson to help increase supply and expand access to authorised SARS-CoV-2/COVID-19 vaccines,” said Sanat Chattopadhyay, executive vice president and president, Merck Manufacturing Division.
The manufacturing agreements follow Merck & Co’s announcement in January that it had ended its own COVID-19 vaccine programme, after reviewing disappointing phase 1 results for its candidates V590 and V591.
Although both V590 and V591 were generally well-tolerated in the phase 1 trials, immune responses for the candidates were inferior to those observed in recovered COVID-19 patients as well as those reported for other vaccines.
Merck & Co said that it will continue to advance clinical programmes for two novel therapeutics targeting SARS-CoV-2, the virus which causes COVID-19.
This includes a potentially first-in-class recombinant fusion protein known as MK-7110, which is designed to target a novel immune pathway checkpoint believed to be involved in the body’s inflammatory response to the novel coronavirus.
The second treatment, MK-4482 or molnupiravir, is an investigational oral antiviral candidate that Merck & Co is developing with Ridgeback Bio.
The antiviral agent is already being evaluated in phase 2/3 clinical trials in hospital and outpatients settings, with a primary completion date set for May 2021.