The Register Citizen (Torrington, CT)
Moderna second firm to tout vaccine efficacy
Initial clinical tests were effective for a COVID-19 vaccine candidate from Moderna — with the vaccine having far easier storage requirements than one from Pfizer that needs to be kept frozen at nearly 100 degrees below zero.
Moderna shares closed at $97.95 for a 10 percent gain Monday, on the heels of the Cambridge, Mass.-based company reporting a vaccine efficacy of 94.5 percent. That was slightly above the efficacy Pfizer reported last week for its own vaccine candidate, which is being developed partly at Pfizer’s Groton lab and another in Pearl River, N.Y. Both companies must clear safety
trials and win approval from the Food & Drug Administration before physicians can begin inoculations.
Moderna’s vaccine candidate has been developed in part with funding from the U.S. Department of Health & Human Services, with HHS having committed more than $950 million to the research effort and $1.5 billion for manufacturing.
HHS has committed billions of dollars more to possible COVID-19 vaccines from AstraZeneca; Janssen Pharmaceuticals and Johnson & Johnson; and Sanofi alongside GlaxoSmithKline, with Sanofi having a research center in Meriden. Pfizer and Novavax have manufacturing contracts in hand from HHS.
Moderna CEO Stephane Bancel called it “a pivotal moment” in the company’s efforts to produce a vaccine. The company indicated it will file in the coming weeks for an Emergency Use Authorization from the FDA, without specifying a target date.
“Since early January, we have chased this virus with the intent to protect as many people around the world as possible,” Bancel was quoted saying in a news release. “All along, we have known that each day matters.”
A COVID-19 vaccine task force convened by Gov. Ned Lamont plans to make vaccines available to health-sector workers, nursing homes and other vulnerable populations before a broader rollout. Lamont confirmed Monday during an online news conference that the Connecticut Department of Public Health plans to undertake its own analysis of efficacy and safety data for vaccines approved for use by the FDA, adding he does not anticipate that process to delay the distribution of vaccines in Connecticut.
“This is going to take months — so that’s why what we can do to bend the curve now is a bridge to the vaccine that will make an enormous, enormous difference,” Lamont said.
Last Friday, New York Gov. Andrew Cuomo described the timeline to get a vaccine as “a further horizon than most people think” and that his own assumptions are anywhere from six to nine months. He confirmed he has conferred with Lamont to coordinate any fresh limitations on business and social gatherings.
“To the extent people say, ‘Well, you know, the vaccine is right around the corner so we can start to relax because the vaccine is here’ — the vaccine is not here,” Cuomo said.
The chairman of Stamford Health’s infectious diseases department said convincing people to take the vaccine could be a major challenge, given the limited time to gather data on efficacy and safety which is typically accumulated over multiple years.
“There’s still a lot of unknowns and we always have people who are afraid of vaccinations,” said Dr. Michael Parry of Stamford Health. “It’s shown to be effective for two months, but is it effective for two years?”
Last week, the Trump administration announced agreements with mass pharmacy and retail chains to serve as vaccination destinations, including CVS Health, Stop & Shop, Walmart, Costco, Rite Aid and Walgreens.
CVS issued a statement last Thursday confirming its clinics will administer vaccines, with a spokesperson not providing additional insights Monday on how the chain will handle any large influx of demand. CVS was among the earliest to offer mass testing for COVID-19 with drive-thru testing scheduled in advance online.
On Monday, Stop & Shop confirmed plans to provide no-cost shots at its in-store pharmacies. A Stop & Shop spokesperson indicated Monday that the company plans to follow guidance from HHS and the Centers for Disease Control and Prevention in administering vaccines.
In a “blast fax” last Thursday, the Connecticut Department of Public Health indicated dialysis center patients could be in the early vanguard of vaccinations. The task force is scheduled to meet Thursday night to get an update on plans to distribute vaccines, with the meeting to be webcast on the Connecticut Network online at www.ct-n.com.
Moderna aims to have 20 million doses manufactured by the end of this year and as many as a billion next year, with McKesson to distribute the vaccines to hospitals, pharmacies and clinics if approved by the FDA. Lamont said last week that Connecticut typically receives about 1 percent of vaccines distributed in the United States.
On Monday, Lamont said 4,757 Connecticut residents are now thought to have died of COVID-19 — 22 people over the past three days — with nearly 760 patients hospitalized. More than 4,600 people were diagnosed over the weekend to push past 93,000 people the number in Connecticut who have contracted the virus, with nearly 2.8 million tests having been administered in Connecticut.
Moderna executives are scheduled to speak Wednesday as part of an online investment conference sponsored by Jefferies.
The company issued its first interim analysis based on 95 diagnosed cases of COVID-19 to emerge from the trials, of which 90 were observed in a group of volunteers who took a placebo versus five people who took the vaccine candidate. Of 11 severe cases, none were observed in the group taking the vaccine candidate. About 30,000 people are participating in the Moderna clinical trial.
Moderna stated its vaccine candidate remains stable at temperatures that a normal refrigerator maintains, making for easier distribution and storage than the Pfizer vaccine which requires specialized “ultra-low” freezers. Moderna stated its vaccine candidate has demonstrated stability of its active ingredients for up to 30 days at temperatures between 32 degrees and 46 degrees — a big improvement over its initial expectations of a week — and up to six months frozen at four degrees below zero. The vaccine candidate stays stable up to 12 hours at room temperature.
Both Moderna and Pfizer are using a new technology in which messenger RNA — the molecule that carries genetic instructions to build proteins — is being injected to instruct the body how to create antigens against the virus that causes COVID-19. That is a radical departure from existing vaccine approaches, in which a small amount of virus is injected to allow the body to recognize a virus or disease and generate antigens to fight it.