Vaccines making progress

Moderna gets manufacturing deal, more trials starting soon

Coronavirus vaccine development continues as Cambridgebased Moderna completes enrollment for a Phase 2 trial of its mRNA vaccine candidate and Johnson & Johnson aims to launch clinical testing in the coming weeks.

Five U.S. companies that are leading the coronavirus vaccine race will testify before Congress later this month to address concerns over safety and effectiveness in the rapid development of a desperately needed vaccine.

Officials from AstraZeneca, Johnson & Johnson, Merck, Moderna and Pfizer will field questions on July 21 about the vaccine prospects before the House Energy and Commerce Oversight and Investigations Subcommittee.

Moderna’s highly regarded vaccine candidate, mRNA-1273, saw positive Phase 1 data in May and the company announced Wednesday that enrollment for a Phase 2 study is now complete.

The study, with a cohort of 300 younger adults and 300 older adults, will evaluate the safety of two doses of the vaccine which will be given 28 days apart, according to Moderna.

“I would like to thank the healthy volunteer participants, our partners at clinical trial sites and the dedicated Moderna team for their support in completing enrollment of the Phase 2 study of mRNA-1273, our vaccine candidate against COVID-19,” said Dr. Tal

Zaks, Moderna’s chief medical officer.

Moderna has also finalized a Phase 3 study based on feedback from the Food and Drug Administration that is expected to include 30,000 participants and will start sometime this month.

On Thursday, Moderna also announced a partnership with with ROVI, a European pharmaceutical company, that will provide vial filling and packaging capacity for the vaccine at a facility in Madrid.

The large-scale manufacturing effort will support the production of hundreds of millions of doses of the vaccine candidate, according to Moderna.

“We would be thrilled for ROVI to form part of the solution to this pandemic that is affecting all of us and to support Moderna in supplying it on a wide scale,” said Juan Lopez-Belmonte, CEO of ROVI.

Another leader in the coronavirus vaccine race is Johnson & Johnson.

The company recently selected a final vaccine candidate and is working around the clock, “so we can be in a position to actually begin clinical testing in the coming weeks,” said Johnson & Johnson CEO Alex Gorsky during a virtual health conference held on July 7-8.

He said returning to normal life isn’t guaranteed with a vaccine, and multiple therapeutics and vaccines will likely be needed to end the pandemic.

“A vaccine, while a very critical element to bringing an end to this pandemic, is part of the puzzle. We’re going to need great approaches in therapeutics and antibodies,” said Gorsky.

Other companies hot on the trail of a vaccine include Pfizer, which announced early positive results in 45 subjects for its vaccine candidate earlier this month, and Pennsylvania-based company, Inovio, which also reported strong immune responses in Phase 1 subjects of its DNA-based vaccine.

aP FILE TRIALS AND TRIBULATIONS: Neal Browning receives a shot in the first-stage safety study clinical trial of a potential vaccine for COVID-19 at the Kaiser Permanente Washington Health Research Institute in Seattle in March. The vaccine by Cambridge, Mass.-based Moderna Inc., generated antibodies similar to those seen in people who have recovered from COVID-19 in a study of volunteers who were given either a low or medium dose.

NancY LanE / HERaLD STaFF FILE MOVING FORWARD: Moderna, with offices in Technology Square in Cambridge, is gearing up for its second phase of clinical trials for a potential vaccine for the coronavirus.

aP FILE FIGHTING BACK: Alex Gorsky, CEO of Johnson & Johnson, right, seen with President Trump in the White House in Washington, D.C., in January, said his company has selected a vaccine candidate and is getting ready to start clinical trials, but added that therapeutics and antibodies will also be key in fighting the virus.