Brokered by the Biden administration, the deal between the two drugs giants invokes the US Defense Production Act, which will award Merck priority in securing equipment needed to upgrade its plants, including acquiring machinery, bags, tubing and filtration systems.

Under the arrangement, Merck will dedicate two of its US plants to manufacturing the vaccine developed by J&J subsidiary Janssen. One of the plants will handle fill & finish, another will make the actual vaccine, which uses an adenovirus vector. The plants are not being identified for security reasons.

The US federal government already has a stake in the J&J vaccine, having awarded the healthcare group $2 billion in federal funding for development and clinical trials. In return, healthcare giant is offering the US shots at $10 each. On receiving the EUA last weekend, it said it would deliver 4 million doses immediately and 20 million more by the end of the quarter; however, this is some 17 million doses short of the contracted volume.

Up to now, Johnson & Johnson has been working with CDMOs such as Emergent, which ferments large batches of the vaccine in vats at its US plants as well as in the Netherlands and India. Catalent is handling fill & finish in the US. The FDA’s green light covered the Dutch output but it was not clear whether earmarking it for the US would trigger in view of Europe’s new export authorization mechanism. India thwarted AstraZeneca’s plan to supply other geographies from there.

While utilizing Merck’s large capability could help J&J fulfill its contract with the federal government, some commentators noted that retooling of production facilities coud take several months, by which time demand may have waned. Others recalled, however, that the healthcare group has said that parallel to the current rollout, it would begin work in modifying its technology to take account of virus variants.

Merck’s move is the first by a US drugmaker to toll manufacture a Covid vaccine for another player. The first to come forward in Europe was France’s Sanofi, which agreed to produce for Pfizer and BioNTech at its plant in Frankfurt, Germany, and later said it would turn over a plant in France to produce the J&J vaccine. Bayer has agreed to support German biotech CureVac’s Covid shot at one of its German facilities. Swiss pharma giant Novartis said in late January it was exploring whether it could deploy its own manufacturing network to boost European supply, but no details have emerged.

Novavax hopes for EUA in second quarter

US biotech Novavax said this week it hopes to apply to the FDA for an Emergency Use Authorization (EUA) for its Covid-19 vaccine in the second quarter. The UK is thought to be close to approving the candidate, due to a successful Phase 3 trial with 15,000-participants, and reports suggest that the European Medicines Agency may also give the green light soon.

The going may be tougher in the company’s home market, due to a lack of data from a Phase 3 trial in the US and Mexico that only recently completed enrolling its 30,000 subjects. Novavax CEO Stanley Erck told broadcaster CNBC that the “hope and expectation is that the FDA will agree to review the UK data.”

US and UK diverge on Covid vaccine dose spacing

That the FDA would accept UK data in the absence of figures from the US could seem doubtful as the two countries’ scientists are already at loggerheads over spacing of coronavirus vaccines. Anthony Fauci, the top US infectious diseases expert, rejects delaying a second injection in order to  vaccinate the population more quickly – the exact opposite of what UK experts are recommending and some in the US political sector are urging.

Fauci said this week that he and his British counterparts had agreed to disagree about what was the right approach. The US expert cited research showing that a two-dose regimen allows the body to better deal with the more transmissible variants. He added that there is insufficient evidence of the benefit of a single dose and no data showing how long the immunity conferred by one shot would last.

Author: Dede Williams, Freelance Journalist