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Moderna seeks FDA approval for emergency use of its COVID-19 vaccine

By Jonathan Saltzman Boston Globe

Moderna asked federal regulators Monday to authorize emergency use of its experimental COVID-19 vaccine, after complete results from a late-stage study showed the two-shot regimen was more than 94 percent effective at preventing the disease and 100 percent effective at warding off severe cases.

If the Food and Drug Administration approves the Cambridge biotechnology company’s request, people at high risk for catching the coronavirus or developing life-threatening infections could start getting vaccinatedas early as Dec. 21, Moderna said. The first wave of recipients would be likely to include front-line health care workers and the elderly.

The final efficacy results from a clinical trial of 30,000 volunteers were almost identical to those in an interim analysis released by the company two weeks ago. The updated data set the stage for the possibility that at least two vaccines — Moderna’s and another developed by Pfizer and its German partner, BioNTech — will be available on a limited basis in the United States by the end of the year.

“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1 percent efficacy and, importantly, the ability to prevent severe COVID-19 disease,” Moderna’s chief executive, Stephane Bancel, said in a statement. “We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death.”

Moderna’s stock rose more than 20 percent Monday, closing at $152.74 in Nasdaq trading.

Moderna is the second vaccine maker to ask the FDA for an “emergency use authorization,” which the agency employs to speed the rollout of promising drugs and other products before weighing full approval. Pfizer, the New York-based pharmaceutical giant, and its partner BioNTech filed the first application on Nov. 20.

Moderna also applied Monday to European drug regulators for conditional approval of the vaccine, close on the heels of the Pfizer team.

An advisory committee to the FDA will probably discuss Moderna’s trial data and make recommendations about the vaccine on Dec. 17, according to the company. That would be exactly a week after the same committee considers data from Pfizer’s late-stage trial.

Another committee that advises the Centers for Disease Control and Prevention is expected to vote Tuesday on which people should receive the first supplies of vaccines.

Ray Jordan, a Moderna spokesman, said that if everything goes smoothly, the FDA could grant emergency use of the company’s vaccine aroundDec. 18 to 20 and that, realistically, the first people could start getting vaccinated on Dec. 21.

Moncef Slaoui, chief scientific adviser for Operation Warp Speed, the federal program that has bankrolled a handful of vaccine candidates, including Moderna’s, with billions of dollars, said it plans to ship vaccines to immunization sites within 24 hours of approval.

A Pfizer spokesman said the company didn’t have a date for when people might start getting its vaccine, assuming the FDA authorizes emergency use. Pfizer has a plant in Andover that is helping to make the vaccine.

Dr. Anthony Fauci, the nation’s top infectious disease expert, said last month that as many as 20 million people in the United Statescould get coronavirus vaccinations by year’s end. By then, he told a virtual conference held by the life sciences news site STAT, there could be roughly 25 million doses of vaccine available from Pfizer and 15 million doses from Moderna.

Both vaccination regimens require two shots a few weeks apart,so that would mean about 20 million people could get protection — a big step forward, though only a fraction of the US populationof some 330 million.

Most Americans aren’t expected to start getting vaccinated until spring or summer of 2021. The virus has infected more than 13.4 million people in the United States and killed more than 266,000.

Moderna on Monday summarized final data that had been scrutinized by an independent monitoring board. The board analyzed 196 coronavirus cases diagnosed among the 30,000 study participants who received two shots four weeks apart and then went about their daily lives. Half of the participants got the vaccine. The other half got placebo shots.

The analysis found that only 11 of the 196 people who came down withCOVID-19 had gotten the vaccine. The other 185 cases occurred in recipients of the placebo. That indicated the vaccine has an efficacy rate of 94.1 percent— virtually the same rate as the 94.5 percent disclosed by the company after the first 95 coronavirus cases were diagnosed. It’s a remarkable showing for any vaccine, let alone one based on novel technology.

Thirty of the 196 coronavirus cases in the latest analysis were deemed severe, including one that resulted in a participant’s death. All 30 severe cases were diagnosed in volunteers who got the placebo.

The vaccine was effective regardless of the age, race, ethnicity, and gender of volunteers, according to Moderna. In an indication of the diversity of trial participants, Moderna said the 196 volunteers who became ill with COVID-19 included 33 adults who were at least 65 years old and 42 participants who identified themselves as Hispanic, Black, Asian-American, or multiracial.

The studyfound no serious safety concerns. The most common side effects included pain at the injection site, fatigue, achiness, and headache. Side effects increased in frequency and in discomfort after the second shot.

Both the Pfizer and Moderna vaccines rely on synthetic messenger RNA, a variation on the natural substance, which directs protein production in cells throughout the body. The vaccines contain custom-made messenger molecules that instruct cells to create a part of the coronavirus and then stimulate the immune system to make antibodies to fend off the disease. No mRNA vaccine has ever been approved.

Moderna, which was launched 10 years ago with backing from the Cambridge venture capital firm now called Flagship Pioneering, currently has no products on the market. If it wins FDA approval, the vaccine could generate $13 billion in sales next year, Goldman Sachs analyst Salveen Richter said in a recent note to investors.

The company began manufacturing the vaccine at its plant in Norwood in early February and has ramped up production since then. Moderna said it remains on track to produce 500 million to 1 billion doses globally next year.

In addition to the Norwood plant, Moderna has a 10-year agreement with a Swiss company to manufacture up to 1 billion doses a year for worldwide use at facilities overseas and in the United States, including in Portsmouth, N.H.

Moderna has deals with other companies to help fill vials with the vaccine and package them.

Under Operation Warp Speed, McKesson Corp., of Texas, will be a central distributor for vaccines that win approval from US regulators.

There are more than a dozen coronavirus vaccine candidates in late-stage trials globally. They use a variety of approaches, and no company could produce enough of one to protect the world’s 7.8 billion people. No one knows how long any of the vaccines might confer immunity, but the answer is likely to emerge in coming months.

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