Moderna to request emergency authorization of coronavirus vaccine

Moderna to seek emergency authorization for COVID-19 vaccine

Moderna to request emergency authorization of coronavirus vaccine

Drug maker Moderna announced today that it will request an emergency use authorization (EUA) from the Food and Drug Administration (FDA) for its COVID-19 vaccine candidate, and the company's CEO hinted that distribution of the vaccine could begin by Christmas.

In a press release, company officials said that the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC), which will make the final decision on authorization, will ly meet on Dec 17 to review safety and efficacy data on mRNA-1273—Moderna's messenger-RNA–based vaccine. If an EUA is granted, doses will be shipped out shortly thereafter, the company said.

Moderna also said it will submit an application for conditional marketing authorization from the European Medicines Agency, the body that regulates vaccines and therapeutics for the European Union.

Primary analysis shows 94% efficacy

The Moderna announcement was accompanied by a primary efficacy analysis of data from a phase 3 trial involving 30,000 participants, half of whom received mRNA-1273. The analysis found that the vaccine's efficacy against COVID-19 was 94.1%—just  slightly lower than the 94.5% efficacy found in the first interim analysis announced on Nov 16.

The primary analysis was 196 COVID-19 cases in trial participants. Of those cases, 185 were observed in the group that received placebo, and 11 were in the vaccine group.

Secondary end point analysis found 30 severe COVID-19 cases, all of which were in the placebo group. The efficacy of the vaccine was consistent across different age, gender, and racial and ethnic groups.

No serious safety concerns were identified.

“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.

1% efficacy and importantly, the ability to prevent severe COVID-19 disease,” Moderna CEO Stéphane Bancel, MBA, said in the press release.

“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.”

In an interview this morning with CNBC, Bancel laid out a possible timeline for approval and distribution of the vaccine.

“It is highly possible, that between the 17th and Christmas, [that] the product is approved,” Bancel said, noting that the FDA could issue an EUA within a few days of the VRBPAC meeting. “We'll be able to first ship products as soon as we get approval.”

Moderna says that it expects to have approximately 20 million vaccine doses available by the end of 2020, enough for 10 million people to be immunized with the two-dose vaccine.

Pfizer and BioNTech have also requested an EUA for their two-dose vaccine candidate, and estimate they will have 50 million doses available globally by the end of the year. The FDA's VRBPAC is scheduled to review the Pfizer/BioNTech vaccine on Dec 10.

Vaccine allocation

With the potential for two COVID-19 vaccines to be available by mid-to-late December, the next question is who should be the first in line to get vaccinated.

That will be on the agenda at tomorrow's emergency meeting of the Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP), a group of experts that makes recommendations to the agency on distribution of vaccines.

Last week, ACIP members indicated that healthcare workers and people in long-term care facilities (phase 1a) should be the first to be vaccinated, followed by essential workers (phase 1b) and adults with high-risk medical conditions and those over 65 (phase 1c). But the committee did not vote on those recommendations.

ACIP chair Jose Romero, MD, the chief medical officer for the Arkansas Department of Health, told CNN that the group is holding the emergency meeting and will vote on its recommendations tomorrow because it wants to make its advice public before the FDA issues an EUA for either, or both, of the vaccines.

“We foresee imminent authorization if this vaccine is shown to be effective and safe in the near future and we want to be at the point where we are providing appropriate guidance to the states and jurisdictions for the use of these vaccines,” Romero said.

The initial doses of vaccine will only be enough to cover a fraction of the phase 1 population. There are an estimated 21 million healthcare workers in the United States, 3 million people in nursing homes, 87 million essential workers, 53 million adults over age 65, and more than 100 million people with high-risk conditions.

The chief science advisor for Operation Warp Speed, the federal government's effort to speed up development and delivery of COVID-19 vaccines and therapeutics, said last week that the government is prepared to send out the first 6.4 million doses to states within 24 hours of an EUA being granted. The doses will be distributed to states their populations, but state officials will decide how the doses are distributed.

Источник: https://www.cidrap.umn.edu/news-perspective/2020/11/moderna-seek-emergency-authorization-covid-19-vaccine

Moderna becomes second company to request emergency FDA authorization for COVID-19 vaccine candidate

Moderna to request emergency authorization of coronavirus vaccine
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Biotech company Moderna applied Monday for an emergency use authorization from the U.S. Food and Drug Administration after receiving more good news about the safety and effectiveness of its candidate COVID-19 vaccine.

Moderna will be the second vaccine maker to request authorization from the federal government after similarly positive results for Pfizer and its German collaborator BioNTech's candidate vaccine.

Moderna's latest findings, according to a company press release, showed that of 196 people in the clinical trial who caught COVID-19, 185 of them had received the placebo, while only 11 received the active vaccine. That works out to an effectiveness rate above 94%.

Of the 30 participants who suffered severe disease, all were in the placebo group, which suggests the vaccine prevents both mild and serious disease. One placebo recipient died.

In Dr. Fauci's words: Why Americans shouldn't fear a COVID-19 vaccine authorized by the FDA

Effectiveness was consistent across age groups, as well as race and ethnicity. The 196 participants with cases of COVID-19 included 33 adults over 65 and 42 who identified as Hispanic, Black, Asian American or multiracial.

The Moderna vaccine, called mRNA-1273, also has been shown to be safe, with no new safety concerns identified. It caused side effects in the majority of recipients, usually fever and aches lasting a day or two. 

The Cambridge, Massachusetts-based company, said it expects that the FDA's advisory committee will discuss mRNA-1273 on Dec. 17, a week after it meets to discuss Pfizer's vaccine, and authorization is expected to come a few days after each meeting.

“These results are stunning,” said Dr. Robert Wachter, chairman of the department of medicine at the University of California-San Francisco, adding that he is particularly impressed by the vaccine's success in preventing serious disease. “This is a remarkably effective vaccine and, with results that, a game-changer.”

Moncef Slaoui, who co-leads the government's Operation Warp Speed, which has overseen the development of Moderna's vaccine and helped finance production of Pfizer's, also was impressed with the results and the novel mRNA technology behind both.

“I think the Moderna data continue to support how exceptionally effective mRNA vaccines are,” he said. He also touted the effectiveness against severe disease, “and also 87% protection in subjects above the age of 65, the most impacted group in our population.”

Moderna reported a 95.4% effectiveness rate for its coronavirus vaccine in an interim analysis earlier this month. (Photo: Joe Raedle / Getty Images News via Getty Images)

Dr. Peter Hotez, a pediatrician and co-director of the Texas Children’s Hospital Center for Vaccine Development, called the news “really impressive, with the caveat that it’s a company press release.”

Hotez said the vaccine provided so much protection against serious illness that it may be unethical to continue allowing participants in other clinical trials to receive a placebo. 

Moderna's president, Dr. Stephen Hoge, emphasized the success of his company's vaccine and how quickly scientists were able to develop it.

“Everything on this has gone faster than expected,” he said. “The data is truly exciting.”

Hoge said the company decided to file for FDA authorization at this point, because “there's nothing more we would do. … We passed the baton.”

Moderna trial conducted 'to the gold standard'

The trial has been the same size and scope as for any vaccine. The only reason the company is requesting an emergency authorization instead of full FDA approval is because no one wants to wait a year or two to see how long the vaccine remains protective. Long-term effectiveness will be determined later, and people will receive booster shots if needed.

“These vaccines have developed tremendous amounts of data,” Hoge said. “The Phase 3 ones – ourselves and Pfizer – have been conducted to the gold standard. Hopefully, people have confidence” in them. 

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The pressure is now on, Hoge said, to produce the promised number of vaccine doses: 20 million in the next month and at least 80 million more next year for the U.S. alone.

The company has started producing vaccine at its plant in Norwood, Massachusetts, and will ramp up production in the next month with help from contract manufacturer Lonza Biologics, which has a facility in Portsmouth, New Hampshire. 

To win FDA authorization, companies have to show three things: their vaccine is safe, it's more than 50% effective, and it can be produced reliably and safely.

Both Moderna, whose vaccine was developed in collaboration with government scientists, and Pfizer/BioNTech have now met all three requirements. 

To prove safety, the companies had wait until two months after half of their trial participants had received the candidate vaccine.

If someone is going to have a bad reaction to a vaccine, it is ly to occur in the first six weeks after vaccination. Both companies reached that mark without seeing any major or life-threatening problems among trial participants.

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Most volunteers did suffer temporary side effects, including muscle aches, headaches and fatigue for a day or two after vaccination. Side effects were generally worse after the second dose of the two-dose regimen.

Pfizer/BioNTech showed earlier this month that its candidate vaccine, BNT162b2, was 95% effective and submitted a request for FDA authorization Nov. 20.

Moderna released interim effectiveness results this month showing equal effectiveness: 95 trial participants diagnosed with COVID-19, 90 had received a placebo. 

'We need more than two vaccines' to beat COVID-19

There was concern this fall that the companies or the government would try to shorten vaccine development by relying on interim effectiveness results. But because so many people are contracting COVID-19 every day in the United States, it took only a little more than a week for an additional 95 people in Moderna's trial to catch the virus.

Vaccine makers determine effectiveness by comparing the number of trial participants who come down with the disease at least two weeks after the second dose of either the vaccine or the placebo. 

Statistically, once more than about 150 illnesses have been recorded, the effectiveness seen in those cases is very ly to hold true for the larger population.

There are now 3 promising COVID vaccine candidates: This is what we know about them.

The mRNA technology behind Moderna and Pfizer/BioNTech's candidate vaccines turns the body's cells into tiny factories producing the “spike” protein found on the surface of the virus that causes COVID-19. Once the immune system learns to recognize the spike protein, it will attack if it sees it again during an infection.

Novavax, another vaccine developer, which targets the spike protein in a different way, provided an update early Monday on its clinical trials. 

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Two of the three late-stage trials for its NVX-CoV2373 have reached full enrollment, the Gaithersburg, Maryland-based company said, with more than 20,000 participants receiving doses. In a U.K.

trial of 15,000 participants, more than a quarter of the volunteers are over 65, and many volunteers had medical conditions that would make them more susceptible to a severe case of COVID-19, the company said.

More than 4,400 volunteers have signed on to an earlier-stage trial in South Africa, including 245 participants who have medically stable HIV.

Novavax expects to start its large, Phase 3 clinical trial in the United States and Mexico in the coming weeks – slightly later than the company had suggested before. The company has selected more than 100 trial sites, as well as some alternates, and expects to manufacture its vaccine at FUJIFILM Diosynth Biotechnologies in Research Triangle Park, North Carolina.

The U.S. government has awarded Novavax $1.6 billion to test and deliver 100 million doses of its candidate vaccine.

In England: AstraZeneca says its COVID-19 vaccine is 'highly effective' in preventing disease

Pfizer has been promised $1.95 billion to manufacture 100 million doses of its vaccine, and Moderna has received the same to develop, test and manufacture an equal number of doses. 

Johnson & Johnson, and teams from AstraZeneca and Oxford University and Sanofi and GlaxoSmithKline, also have received more than $1 billion each from U.S. taxpayers for their candidate vaccines. Sanofi/GSK have not yet started late-stage safety and effectiveness trials, and the other two are well underway.

AstraZeneca/Oxford has faced scrutiny over interim results from trials in the U.K. and Brazil, released last week, showing 60% effectiveness when its vaccine was given in two equal doses and 90% among a much smaller group that accidently received a half-dose the first time.

Slaoui, of Operation Warp Speed, said he sees no reason why AstraZeneca/Oxford's vaccine should be more effective with a smaller dose, and he and his team are investigating the results and whether they should change the protocols for the American trial. 

“I am concerned that nobody will want to get the 'inferior vaccine'; that is why we are working with AZ to understand whether the 90% level is real and how to reproduce it,” he said.

Hoge, of Moderna, said people should wait for more results before drawing conclusions about the trial. Although AstraZeneca/Oxford is technically a competitor, he said, he hopes its vaccine is eventually authorized.

“We need more than two vaccines,” Hoge said. “We're not going to get our lives back with two. We need three to four to get our lives back.”

Contact Karen Weintraub at kweintraub@usatoday.com.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input

Read or Share this story: https://www.usatoday.com/story/news/health/2020/11/30/moderna-emergency-fda-authorization-covid-19-vaccine-pfizer/6376336002/

Источник: https://www.usatoday.com/story/news/health/2020/11/30/moderna-emergency-fda-authorization-covid-19-vaccine-pfizer/6376336002/

Moderna COVID vaccine becomes second to get US authorization

Moderna to request emergency authorization of coronavirus vaccine

Moderna’s vaccine is the second to be recommended for emergency-use authorization in the United States.Credit: Paul Hennessy/NurPhoto/Getty

A week after granting an emergency-use authorization for the country’s first COVID-19 vaccine, US regulators have followed with a second: another RNA vaccine, this one made by Moderna of Cambridge, Massachusetts.

The emergency-use authorization followed quickly after a panel of external advisers to the US Food and Drug Administration (FDA) voted unanimously, with one abstention, to recommend use of the vaccine on 17 December. One week earlier, the agency authorized a similar vaccine made by Pfizer of New York City and BioNTech of Mainz, Germany, about a week after UK regulatory authorities did the same.

The speed of these authorizations reflects the urgency of the pandemic, and is a testament to the scientific advances that made rapid vaccine development possible, said immunologist James Hildreth, president of Meharry Medical College in Nashville, Tennessee, at the panel meeting on Thursday. “To go from having a sequence of a virus in January to having two vaccines available in December is a remarkable achievement.”

The authorization is a first for Moderna, a ten-year-old biotechnology company that had long pledged to revolutionize medicine by harnessing RNA as a therapeutic agent, but had yet to push a drug or vaccine all the way through to the clinic. It will join a growing list of organizations with coronavirus vaccines that are being deployed around the world, including teams in China and Russia.

In the United States, the vaccines offer a glimmer of hope amid the prospect of a tough winter. The country is logging thousands of deaths from COVID-19 each day, and this is expected to rise over the winter holiday season.

Coronavirus infections are so rampant that Moderna was able to reach the primary endpoint of its trial five months earlier than expected, said Jacqueline Miller, senior vice-president and head of infectious diseases at the company.

RNA vaccine

Moderna’s vaccine, which was developed in collaboration with the US National Institute of Allergy and Infectious Diseases, works in the same way as the one produced by Pfizer and BioNTech.

Both consist of RNA molecules encased in lipid nanoparticles.

The RNA in both vaccines encodes a slightly modified form of the SARS-CoV-2 protein known as spike, which enables the virus to infect human cells.

Once taken up by cells, the RNA is used to produce the protein, which then triggers an immune response. The RNA does not enter the nucleus where the cell’s genome resides, and is degraded by the cell within a day of the injection.

COVID vaccine excitement builds as Moderna reports third positive result

Pfizer’s vaccine, Moderna’s seems to be highly effective — about 94% — at preventing symptomatic SARS-CoV-2 infections. Its safety profile is also similar to Pfizer’s, with fatigue, headaches and pain at the site of injection among the most often cited side effects.

Since the Pfizer vaccine was rolled out in the United Kingdom and the United States, there have been occasional reports of recipients experiencing severe allergic reactions called anaphylaxis after being injected.

There have been no signs of such reactions so far in the Moderna trial, which excluded people who have had anaphylactic reactions to previous vaccines, but not those with other allergies, such as reactions to food.

The two vaccines differ in the composition of the lipid nanoparticle that encases the RNA, and Moderna’s formulation allows the vaccine to be stored at higher temperature than Pfizer’s, which must be kept at −70 °C, much colder than a normal freezer.

Moderna’s vaccine can be stored in a −20 °C freezer for 6 months, and in a refrigerator (at about 4 °C) for 30 days.

This promises to streamline the logistics of deploying the vaccine, particularly in rural areas and in countries with limited health-care infrastructure.

Continuing trials

FDA advisers spent much of the 17 December committee meeting discussing when and how to offer a vaccine to participants in the placebo arm of Moderna’s trial after an emergency-use authorization is granted.

Once a coronavirus vaccine becomes available, participants might choose to leave the trial to guarantee that they can get a jab.

Maintaining the integrity of clinical trials after vaccine authorization — to collect data on long-term safety and the duration of protection — is a looming challenge for developers.

Last week, Pfizer proposed that when its participants become eligible to receive a vaccine as part of a national roll-out, study investigators will tell them whether they received the vaccine or a placebo.

Moderna has instead proposed to ‘unblind’ its whole trial at once after it receives an emergency-use authorization, telling all of its participants which treatment they have received, and offering to vaccinate those in the placebo arm using doses that had already been set aside for the clinical trial.

Why emergency COVID-19 vaccine approvals pose a dilemma for scientists:

Some FDA advisers cautioned that this approach would sacrifice valuable weeks of data collection, and allow some participants to receive the vaccine ahead of others in similar priority groups in their communities.

Others argued that although the approach is not ideal, it might be necessary given the complexity of the vaccine roll-out in the United States, where individual state and local governments will set their own priorities.

“It’s such a hodgepodge here, it’s impractical,” said biostatistician Jeannette Lee at the University of Arkansas for Medical Sciences in Little Rock.

Offering trial participants the vaccine could help the company keep them enrolled in the study, so that it can continue to collect data about safety and immunity, said Lindsey Baden, an infectious disease specialist at Brigham and Women's Hospital in Boston, Massachusetts, who was asked by Moderna to speak about the issue to the committee. Some healthcare workers who participated in the trial were already leaving to get the Pfizer vaccine, he said. “If we lose our volunteers the opportunity to learn anything further will be substantially impaired,” he said. “We have to be practical.”

Источник: https://www.nature.com/articles/d41586-020-03593-7

Moderna to request emergency FDA approval for coronavirus vaccine

Moderna to request emergency authorization of coronavirus vaccine

A second pharmaceutical company said Monday it would ask for government approval of its COVID-19 vaccine after it was shown to be highly effective and had been able to stave off severe cases of the coronavirus.

Moderna Inc. announced that a clinical trial had shown its vaccine — named mRNA-1273 — had an efficacy of 94.1% and had been able to prevent 100% of “severe” cases of the pandemic disease, the company claimed in a statement Monday.

The company also announced it would be applying for an emergency use authorization from the U.S. Food and Drug Administration — making its vaccine the second to ask the government for emergency approval to begin distribution to the American public. It was also asking for approval from the European Medicines Agency — a medical supervisory agency of the European Union.

Emergency use authorizations, known as EUAs, are formal approvals by the FDA for a previously unapproved or undeveloped medical product to be used during a national disaster.

On Nov. 20, Pfizer and BioNTech — the first company to announce successful vaccine study results — applied for FDA authorization of their COVID-19 vaccines.

The FDA’s advisory committee will review both of the applications in December, CNN reported.

If the vaccine is approved, the first of two doses — which would be administered about a month apart — could begin as early as Dec. 21, a Moderna spokesperson told The New York Times.

Although the federal and state governments agree that health care workers — around 21 million professionals — should receive the first available doses, President Donald Trump’s administration has said that state officials will have “ultimate authority” for assigning vaccine priority, Politico reported.

Related

What to know about the vaccines:

  • Both Moderna’s and Pfizer’s vaccines are mRNA vaccines, which means that un the annual flu vaccine or some childhood vaccines, they don’t contain any live or dead novel coronavirus and cannot give you COVID-19.

    Instead, they contain genetic instructions that tell your body to make a harmless spike protein — the same protein the novel coronavirus uses to attack healthy cells. This triggers an immune response that prepares your body to respond should an actual novel coronavirus encounter occur.

  • While the vaccine will not give you COVID-19, and no serious side effects have been noted, some have reported mild to moderate effects following vaccination, including injection site pain, fatigue, muscle pain, joint pain and headache, according to the Moderna report.
  • Both vaccines require two doses, given either 21 or 28 days apart.
  • Despite optimism from public health officials, Moderna notes “the forward-looking statements in this press release are neither promises nor guarantees,” while Pfizer outlines in a lengthy paragraph the “substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.

The caution refers to technology still being developed, the FDA has never approved mRNA vaccine, the findings are still not peer-reviewed and significant supply chain and distribution issues could arise.

Moderna

  • In addition to announcing efficacy, Moderna also announced Monday its vaccine will remain stable for 30 days in a standard home or medical refrigerator — a time-frame increase from an earlier estimate of a week of refrigeration.

    In a freezer below -20 degrees C (-4 degrees F) the vaccine could remain stable for up to six months. Once taken the refrigerator to administer, the vaccine will remain stable for up to 12 hours, according to a company release.

  • Moderna’s study pool is 30,000 people ages 18 and older.

    Of that pool, 25,654 have received their second vaccination, according to Deseret News reporting from Nov. 16. The pool includes more than 7,000 Americans over the age of 65, plus 5,000 people who are medically high-risk (diabetes, severe obesity and cardiac disease).

    It also includes 11,000-plus participants from communities of color, with more than 6,000 people who identify as Hispanic or LatinX and more than 3,000 who identify as Black or African American.

  • Moderna is part of Operation Warp Speed, the federal government’s program to fast-track a COVID-19 vaccine, and has received more than $955 million to aid in vaccine development. In August, the government also contracted to buy 100 million doses of the Moderna vaccine for $1.5 billion, with the option to buy more.

Pfizer

  • Pfizer was not part of Operation Warp Speed; however, in July the U.S. government bought 100 million doses of the Pfizer vaccine for $1.95 billion — with the potential to buy 500 million more, according to a company press release earlier this summer. In that release, Pfizer also indicated that Americans would receive the vaccine for free, “consistent with the U.S. government’s commitment for free access for COVID-19 vaccines.”
  • Pfizer’s phase 3 clinical trial data came from more than 43,000 people worldwide, among whom 38,955 have received a second dose of the vaccine candidate as of Nov. 8. Of these, 42% of global participants and 30% of US participants have racially and ethnically diverse backgrounds.
  • Pfizer and BioNTech are continuing to enroll participants in their study until they reach a total of 164 confirmed COVID-19 cases. They will also study if the vaccine is effective for those who have already had COVID-19. All participants will be monitored for two years after the second dose to gauge long-term efficacy and any safety issues.
  • Pfizer and BioNTech’s mRNA vaccine requires extensive cold-chain storage at -70 degrees C (-94 degrees F) and will be shipped in special insulated containers using dry ice that must be replenished every few days.

Источник: https://www.deseret.com/indepth/2020/11/30/21726651/coronavirus-vaccine-maderna-fda-pfizer-covid19-emergency-use-approval

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