Tag Archives: Moderna

U.S. inks $1.5 billion deal with Moderna for 100 million doses of COVID-19 vaccine

By Jeff Mason and Carl O’Donnell

(Reuters) – The United States has entered an agreement with drugmaker Moderna Inc to acquire 100 million doses of its potential COVID-19 vaccine for around $1.5 billion, the company and White House said on Tuesday.

The United States in recent weeks has made deals to acquire hundreds of millions of doses of potential COVID-19 vaccines from several companies as part of its Operation Warp Speed program, which aims to deliver a vaccine in the country by the end of the year.

Moderna’s price per dose comes to around $30.50 per person for a two dose regimen.

With the exception of its deal with AstraZeneca, which offered a lower price per drug in exchange for upfront research and development costs, all the deals price COVID-19 vaccines between $20 to $42 for a two dose course of treatment.

Moderna’s vaccine candidate, mRNA-1273, is one of the few that have already advanced to the final stage of testing and is on track to be completed in September, the company said this month.

Moderna’s deal with the U.S. only pays out in full if the drugmaker hits certain unspecific timing benchmarks for vaccine delivery.

The United States has advanced purchase agreements with Johnson & Johnson, AstraZeneca Plc, Pfizer Inc and BioNTech SE, and Sanofi SA and GlaxoSmithKline Plc for their respective vaccine candidates.

The agreements would lock in more than 500 million doses of COVID-19 vaccine for the U.S., assuming that the companies involved receive regulatory approval. Some deals also give the United States an option to purchase additional doses.

The U.S. government previously gave Moderna around $1 billion to fund its research efforts, bringing total U.S. funding to around $2.5 billion.

Other countries, including Japan, the United Kingdom and Canada, have forged similar deals with drugmakers.

(Reporting by Jeff Mason and Carl O’Donnell; Editing by Peter Henderson, Chris Reese and Tom Brown)

Moderna says COVID-19 vaccine pricing to ensure broad access

(Reuters) – Moderna Inc plans to price its experimental coronavirus vaccine in a way that ensures broad access, it said on Wednesday, adding that it did not intend to conduct late-stage trials of the vaccine outside the United States.

Moderna began the U.S. government-backed trial on Monday, among a handful of companies that have started final testing of their experimental vaccines on tens of thousands of healthy volunteers.

Chief Executive Officer Stéphane Bancel declined to comment on the specific price of the vaccine on a conference call with analysts.

“We are highly aware of our obligation during the pandemic phase to be responsible in how we price the vaccine,” Bancel said.

The Financial Times reported on Tuesday, citing unnamed sources, that the company was planning to price the vaccine at $50 to $60 per course, at least $11 more than another vaccine from Pfizer Inc and BioNTech.

Moderna executives also said the enrollment for the late-stage trial was on track and the company had seen tremendous interest from clinical sites.

(Reporting by Manas Mishra in Bengaluru; Editing by Saumyadeb Chakrabarty)

Moderna’s COVID-19 vaccine candidate moves into late-stage trial

By Manojna Maddipatla

(Reuters) – Moderna Inc. said on Monday it had started a late-stage trial to test the effectiveness of its COVID-19 vaccine candidate, the first such study under the Trump administration’s program to speed development of measures against the novel coronavirus.

News of the study, which will test the response to the vaccine in 30,000 adults who do not have the respiratory illness, pushed shares in Cambridge, Massachusetts-based Moderna up more than 8% before the bell.

The federal government is supporting Moderna’s vaccine project with its Operation Warp Speed program. Moderna has received nearly $1 billion from the U.S. government, which has chosen it as one of the first to enter large-scale human trials.

More than 150 coronavirus vaccine candidates are in various stages of development, with 23 prospects in human trials across the globe and Moderna’s candidate among the farthest along in development.

“Having a safe and effective vaccine distributed by the end of 2020 is a stretch goal, but it’s the right goal for the American people,” National Institutes of Health Director Francis Collins said in a release from the NIH announcing the start of the study.

The large late-stage trial is designed to evaluate the safety of Moderna’s mRNA-1273 and determine if the vaccine can prevent symptomatic COVID-19 after two doses.

The study also seeks to answer if the vaccine can prevent death caused by COVID-19 and if just one dose can prevent symptomatic COVID-19.

Trial volunteers will receive two injections about 28 days apart, with volunteers randomly assigned to receive either two 100 micro gram injections of mRNA-1273 or two shots of a saline placebo. The study is blinded, so the investigators and the participants will not know who is assigned to which group.

Results of a small early-stage study published earlier this month showed volunteers who got two doses of Moderna’s vaccine had high levels of virus-killing antibodies that exceeded the average levels seen in people who had recovered from COVID-19.

Moderna said it remains on track to deliver about 500 million doses a year, and possibly up to 1 billion doses a year, beginning 2021.

Brokerage BMO Capital Markets said a U.S. supply deal with Moderna for its vaccine candidate is inevitable, adding that there likely will be deals with other governments as well.

(Reporting by Manojna Maddipatla and Ankur Banerjee in Bengaluru; Editing by Shinjini Ganguli, Lewis Krauskopf and Steve Orlofsky)

Fauci bullish on prospects for U.S. vaccine, not worried about China winning race

By Julie Steenhuysen

(Reuters) – The leading U.S. expert on infectious diseases, Dr. Anthony Fauci, predicted on Wednesday the country will meet its goal of a coronavirus vaccine by year’s end and was unmoved by the prospect that China would get there first.

While there are no guarantees, “I feel good about the projected timetable,” Fauci told Reuters in an interview.

His comments follow promising early stage data for the Moderna Inc’s coronavirus vaccine, released on Tuesday, that was developed with scientists at the National Institute of Allergy and Infectious Diseases, which Fauci directs.

Many experts see a safe and effective vaccine as the only way out of the pandemic that has infected millions and killed more than 575,000 people worldwide.

Fauci said Moderna’s results were especially promising because the vaccine appeared to offer the type of protection seen in a natural infection.

In vaccine development, “one of the things that you hope for is that your vaccine induces a response that’s comparable to a natural infection, because theoretically, the best vaccine you could possibly ever get is a natural infection.”

Moderna’s candidate, which is set to enter the last stage of testing on July 27, is just one of more than a hundred vaccines in development globally, but only one of a few contenders that have earned millions of dollars in backing from Operation Warp Speed, the White House program that aims to deliver more than 300 million doses of a safe and effective COVID-19 vaccine by January.

Fauci, who has become a popular and trusted figure during the coronavirus outbreak, came under criticism from President Donald Trump and some of his Republican allies as Fauci cautioned against reopening the U.S. economy too soon.

Asked how he copes with the attacks on his character and allegiance to the president, Fauci told Reuters, “I don’t let it bother me. What we’re doing with vaccines, what we’re doing with therapeutics, what we’re doing with clinical trials is the real substance,” Fauci said.

VACCINE RACE

As U.S. states have begun to reopen businesses and coronavirus infections have soared, some White House officials have pointed fingers at China, where the virus first emerged late last year.

Fauci was unmoved by the prospect that China could cross the finish line first. Although he said he hopes China succeeds, he does not think they will win the vaccine race, at least not by much.

“I think everybody’s sort of on the same track.” If they do get there, he said, “They’re not going to get it particularly sooner than we get it. That’s for sure.”

Ultimately, he hopes multiple successful candidates prevail. “I don’t worry about anybody getting there first.”

Even if a vaccine succeeds in provoking an immune response, Fauci said it is still not clear how long that protection will last.

“These are questions that don’t have answers right now, because we’re only six months into the outbreak.” He said it may take a year before that immunity question is answered.

A recent Reuters poll found that a quarter of Americans are hesitant about taking a vaccine, voicing concern that the record pace of development could compromise safety. Fauci said he is aware of such concerns.

“It’s understandable, but unjustified,” he said. “We’re not compromising safety; we’re not compromising scientific integrity.”

Fauci said the normal development process of waiting for a vaccine to be proven effective before manufacturing begins wastes precious time.

“If the vaccine doesn’t work, the only thing you’ve lost is money.”

(Reporting by Julie Steenhuysen in Chicago; Editing by Lisa Shumaker)

Moderna Phase 1 results show coronavirus vaccine safe, induces immune response

By Julie Steenhuysen

CHICAGO (Reuters) – Moderna Inc’s experimental vaccine for COVID-19 showed it was safe and provoked immune responses in all 45 healthy volunteers in an ongoing early-stage study, U.S. researchers reported on Tuesday.

Volunteers who got two doses of the vaccine had high levels of virus-killing antibodies that exceeded the average levels seen in people who had recovered from COVID-19, the team reported in the New England Journal of Medicine.

No study volunteers experienced a serious side effect, but more than half reported mild or moderate reactions such as fatigue, headache, chills, muscle aches or pain at the injection site. These were more likely to occur after the second dose and in people who got the highest dose.

Experts say a vaccine is needed to put an end to the coronavirus pandemic that has sickened millions and caused nearly 575,000 deaths worldwide.

Moderna was the first to start human testing of a vaccine for the novel coronavirus on March 16, 66 days after the genetic sequence of the virus was released.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, whose researchers developed Moderna’s vaccine candidate, called the results “good news,” noting that the study found no serious adverse events and the vaccine produced “reasonably high” levels of virus-killing or neutralizing antibodies.

“If your vaccine can induce a response comparable with natural infection, that’s a winner,” Fauci said in a telephone interview. “That’s why we’re very pleased by the results.”

Moderna shares jumped more than 15% in after-hours trading on Tuesday.

The U.S. government is supporting Moderna’s vaccine with nearly half a billion dollars and has chosen it as one of the first to enter large-scale human trials. A successful vaccine could be a turning point for Cambridge, Massachusetts-based Moderna, which has never had a licensed product.

Moderna’s shot, mRNA-1273, uses ribonucleic acid (RNA) – a chemical messenger that contains instructions for making proteins. When injected into people, the vaccine instructs cells to make proteins that mimic the outer surface of the coronavirus, which the body recognizes as a foreign invader, and mounts an immune response against.

The results released Tuesday involved three doses of the vaccine, tested in groups of 15 volunteers aged 18-55 who got two shots, 28 days apart. The groups tested 25, 100 or 250 micro grams of the vaccine.

Adverse events after the second dose occurred in seven of the 13 volunteers who got the 25-micro gram dose, all 15 participants who received the 100 micro gram dose and all 14 who got the 250 micro gram dose. In the highest-dose group, three patients had severe reactions such as fever, chills, headache or nausea. One of these had a fever of 103.28 Fahrenheit (39.6 C).

“We didn’t see any events that are characterized as serious adverse events,” said lead author Dr Lisa Jackson of Kaiser Permanente Washington Health Research Institute in Seattle, referring to reactions that require hospitalization or result in death.

In June, Moderna said it selected the 100-micro gram dose for its late-stage study to minimize adverse reactions.

At that dose, Moderna said the company is on track to deliver about 500 million doses per year, and possibly up to 1 billion doses per year, starting in 2021, from the company’s internal U.S. manufacturing site and strategic collaboration with Swiss drug-maker Lonza.

“It’s a good first step,” said Dr William Schaffner, a vaccine expert at Vanderbilt University Medical Center who was not involved in the study.

“There’s nothing here that would inhibit one from going ahead to the Phase 2/Phase 3 trials,” he said.

In April, Moderna expanded the Phase 1 trial to include adults over 55, who are more at risk of serious disease, with the aim of enrolling 120 volunteers. Moderna said it will follow study volunteers for a year to look for side effects and check how long immunity lasts.

Moderna started its phase 2 trial in May and expects to start a phase 3 trial on July 27.

Phase 1 trials aim to ensure a treatment is safe and help determine an effective dose. Phase 2 trials test a treatment in a larger group and get an early read on effectiveness. Phase 3 trials are conducted in a large group of individuals to confirm efficacy and identify rare side effects. Moderna’s Phase 3 trial will be conducted in 30,000 volunteers.

(Reporting by Julie Steenhuysen in Chicago; Editing by Matthew Lewis and Richard Pullin)