Second vaccine shows promise
Firm says it’s 94.5% effective
Drugmaker Moderna announced Monday that its coronavirus vaccine was 94.5% effective, joining Pfizer as a front-runner in the global race to contain a pandemic that has killed 1.2 million people worldwide.
Both companies plan to apply within weeks to the Food and Drug Administration for emergency authorization to begin vaccinating the public. Officials said the two companies could produce enough vaccine for a little more than 20 million people in the United States by sometime in December, with the first doses going to people with the highest risk, such as health care workers, emergency medical workers and residents of nursing homes.
But a vaccine that would be widely available to the public is still months away,
while the need for one is becoming increasingly urgent.
Dr. Stephen Hoge, Moderna’s president, welcomed the “really important milestone” but said having similar results from two different companies is what’s most reassuring.
“That should give us all hope that actually a vaccine is going to be able to stop this pandemic and hopefully get us back to our lives,” Hoge said. He added: “It won’t be Moderna alone that solves this problem. It’s going to require many vaccines” to meet the global demand.
The pandemic has infected more than 54.8 million people around the world so far. U.S. cases are soaring, setting records every day. There have been more than 11 million cases and 247,000 deaths. Covid-19 is killing more than 1,100 Americans a day, and the last million cases occurred in just six days.
Some states and cities are reinstating lockdowns, restricting gatherings, issuing mask mandates, setting curfews for bars and restaurants, and closing schools once again. Hospitals in some areas are overwhelmed, scrambling to find enough beds for the severely ill. Major grocery chains such as Kroger and Wegmans have begun reimposing limits on purchases of household supplies such as paper towels and tissues.
Despite the virus’s surge, stocks rallied on Wall Street and around the world on rising hopes that the global economy could start returning to normal in the coming months. The Dow Jones Industrial Average gained 470.63 points, or 1.6%, to close at a record high of 29,950.44. Moderna stock was up almost 10%.
Public health officials greeted Moderna’s news with a modicum of excitement, especially when viewed alongside the data released last week by Pfizer — which, in collaboration with BioNTech, reported that its vaccine was more than 90% effective.
Modern a and Pfizer were the first companies to announce interim data from large studies. Ten other vaccine-makers are also conducting Phase 3 trials, including efforts in Australia, Britain, China, India and Russia. More than 50 other candidates are in earlier stages of testing.
The Pfizer and Moderna vaccines far exceeded the FDA’s requirement that coronavirus vaccines be at least 50% effective to receive approval.
Moderna also reported Monday that its vaccine had a longer shelf life under refrigeration and at room temperature than previously reported, which should make it easier to store and use.
Based in Cambridge, Mass., the company developed its vaccine in collaboration with researchers from the Vaccine Research Center, part of the National Institute of Allergy and Infectious Diseases.
Dr. Anthony Fauci, director of the institute, said: “I had been saying I would be satisfied with a 75% effective vaccine. Aspirationally, you would like to see 90, 95%, but I wasn’t expecting it. I thought we’d be good, but 94.5% is very impressive.”
DOUBLING DOWN
At a news briefing Monday, Fauci and Dr. Francis Collins, director of the National Institutes of Health, emphasized that the news did not mean people could let down their guard. On the contrary, they implored the public to “double down” on mask-wearing, social-distancing, hand-washing and avoiding crowds, and to stay that course until vaccines become available.
That message was echoed by the head of the World Health Organization, Dr. Tedros Adhanom Ghebreyesus, who said in a video, “A vaccine on its own will not end the pandemic.”
Stephane Bancel, chief executive of Moderna, said in a statement that the results had provided “the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease.”
Pfizer’s chief executive, Dr. Albert Boula, tweeted congratulations to Moderna.
The companies announced the findings in news releases, not in peer-reviewed scientific journals, and did not disclose the detailed data that would allow outside experts to evaluate their claims. Therefore, the results cannot be considered conclusive. The figures on effectiveness may change as the studies continue.
Scientists not involved with the testing were encouraged but cautioned that the FDA still must scrutinize the safety data and decide whether to allow vaccinations outside a research study.
“We’re not to the finish line yet,” said Dr. James Cutrell, an infectious-disease expert at UT Southwestern Medical Center in Dallas. “If there’s an impression or perception that there’s just a rubber stamp, or due diligence wasn’t done to look at the data, that could weaken public confidence.”
SHELF LIFE
An additional concern is that both vaccines must be stored and transported at low temperatures — minus 4 degrees Fahrenheit for Moderna, and minus 94 degrees Fahrenheit for Pfizer — which could complicate their distribution, particularly to low-income areas in hot climates. Although both vaccines are made of messenger RNA, their temperature requirements differ because they use different, proprietary formulations of fat to encase and protect the mRNA, said Ray Jordan, a Moderna spokesman.
Other coronavirus vaccines being developed will need only refrigeration. If handled improperly, vaccines can become inactive.
But on Monday, Moderna said researchers had found that its vaccine had a longer shelf life in the refrigerator than previously thought: 30 days, not seven. And it will last 12 hours at room temperature, the company said.
Dr. William Schaffner, an infectious disease expert at Vanderbilt University, said the relative ease of handling the Moderna vaccine would give it a big advantage.
“This vaccine presents the opportunity of using doctors’ offices, clinics and pharmacies as vaccination sites,” he said, adding that he would not be surprised, should both vaccines become available, if vaccination sites requested Moderna’s.
So far, studies of the two vaccines have not found serious side effects, but participants have reported sore arms, fatigue, fever, and joint and muscle aches that last for a day or two.
The U.S. government will buy the vaccines and give them to the public for free. But both companies expect to profit, and not to provide their products at cost. Moderna said it would charge other governments from $32 to $37 per dose. The charge to the United States, which has already committed about $2.5 billion to help develop Moderna’s vaccine and buy doses, comes out to about $24.80 a shot, according to Jordan.
Pfizer did not take any money from the U.S. government to develop or test its vaccine. But Operation Warp Speed has promised Pfizer $1.95 billion to provide 100 million doses, which comes out to $19.50 per dose.
Moderna said it could produce 500 million to 1 billion doses in 2021.
It’s working with the Swiss company Lonza and Laboratorios Farmaceuticos Rovi of Spain to make doses of the vaccine outside the United States.
Moderna has received a commitment of $955 million from the U.S. government’s Biomedical Advanced Research and Development Authority for research and development of its vaccine, and the United States has committed up to $1.525 billion to buy 100 million doses.
Moderna has already taken the early steps needed to apply to government agencies in Britain, Canada and Europe to market its vaccine, and the company has made deals to sell 50 million doses to Japan and unspecified amounts to Qatar and Israel.
VACCINE COMMITTEES
As the FDA is taking steps to review safety and efficacy data for what may be the first covid-19 vaccine in the United States, seven states and the District of Columbia have planned an extra layer of scrutiny: committees that would vet any vaccine reviewed by the FDA, a step many public health experts and officials deem unnecessary given a federal review process they describe as meticulous.
The committees are in part a response to the Trump administration’s handling of the pandemic and concerns that political considerations would influence vaccine approvals.
“The people of this country don’t trust this federal government with this vaccine process,” Gov. Andrew Cuomo of New York said in September when announcing his state’s vaccine committee.
The reviews are intended to help persuade a hesitant public to get shots once they are approved, several state officials said in interviews. But some health officials and experts worry that the state reviews could instead create inconsistency and sow doubt about a crucial tool in stopping the global contagion.
Paul Mango, deputy chief of staff for policy at the U.S. Department of Health and Human Services, said state leaders were undermining the expertise of the FDA, which he called the “most rigorous organization in the world.”
“Any delay that the state wants to impose will be a delay in getting its citizens — its most vulnerable citizens — vaccines. We think it is actually counter productive for them to talk about this,” Mango said.
State officials said they did not believe they would slow any vaccinations. They hoped to examine clinical trial data once it became available, conducting their reviews alongside the federal government.
Besides New York, officials in California, Connecticut, West Virginia and the District of Columbia have appointed committees to review coronavirus vaccines offered for FDA approval. Governors in Nevada, Oregon and Washington have joined California’s effort, with each state adding a representative to the panel.
“We’re not to the finish line yet. If there’s an impression or perception that there’s just a rubber stamp, or due diligence wasn’t done to look at the data, that could weaken public confidence.”
— Dr. James Cutrell