Moderna vaccine safe and effective, say US experts

Moderna’s vaccine is safe and 94% effective, regulators say, clearing the way for US emergency authorisation.

The analysis by the Food and Drug Administration’s (FDA) means it could become the second coronavirus vaccine to be allowed in the US.

It comes one day after Americans across the country began receiving jabs of the Pfizer-BioNTech vaccine.

The news comes as the US coronavirus death toll passes 300,000, according to Johns Hopkins University.

Endorsement of the Moderna vaccine by FDA scientists was announced on Tuesday, two days before the vaccine panel meets to discuss emergency approval.

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What were their findings?
The 54-page document said there were “no specific safety concerns” and that serious adverse reactions were rare.

If approved by the team of experts later this week, and by the FDA’s vaccine chief, shipments could begin within 24 hours.

The FDA found a 94.1% efficacy rate out of a trial of 30,000 people, according to the document they released.

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Covid: When can I get vaccinated in the US?
What you need to know about vaccine safety
The most common side effects included fever, headaches, and muscle and joint pain.

Last week, the FDA released similar data from Pfizer before voting to issue approval.

Moderna was founded in 2010 and so far has never had a product approved by the FDA.

The company’s stocks have seen a nearly 700% increase so far this year.

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How does it differ from the Pfizer jab?
The Moderna vaccine requires temperatures of around -20C for shipping — similar to a regular freezer.

The Pfizer jab requires temperatures closer to -75C, making transport logistics much more difficult.

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How will we keep the vaccine cold enough?
Like the Pfizer jab, the Moderna vaccine also requires a second booster shot. Moderna’s second jab comes 28 days after the first.

The company is based in Cambridge, Massachusetts, and has said that if approved, the “vast majority” of its vaccine would be manufactured there.

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Pfizer’s drug is being manufactured in several countries, including Germany and Belgium.

Approval of a second Covid vaccine in the US would be a big deal.

The country is the worst-hit in the world according to the recorded death toll from the pandemic virus and urgently needs more ammunition to fight the virus.

The US has several million doses of the Pfizer-BioNTech Covid vaccine that was authorised for emergency use a few days ago by regulators.

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Although mass vaccination has begun with these, getting access to the Moderna jab in the near future, in addition to more stock of the Pfizer one, would mean many millions more people could be inoculated in the coming months.

The Food and Drug Administration is yet to give the green light for the Moderna vaccine, but if it does, the US could start to receive some of the 200m doses it has pre-ordered. The first lot of 20m could be delivered by the end of December.

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Which other countries have ordered the Moderna vaccine?
The US has agreed to purchase 200m doses of the jab, and 6m could be ready to ship as soon as the vaccine gets FDA approval.

In Canada, the government plans to get two million Moderna doses by March — part of a total 56m doses. On Tuesday, Canadian Prime Minister Justin Trudeau said 168,000 doses should be available before the end of the month.

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The UK has already pre-ordered 7m doses of the Moderna jab.

The European Union last month announced a contract to purchase of 80m doses — with up to 80m more — once the vaccine is deemed safe and effective.

Japan has signed up for 50m Moderna doses, South Korea for 20m, and Switzerland has ordered 7.5m, according to data compiled by the Duke University Global Health Innovation Center.

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A second COVID-19 vaccine likely will receive a thumbs up Thursday from an advisory committee to the U.S. Food and Drug Administration, which authorized the first one a week ago.

This time, the committee is reviewing a vaccine made by Cambridge, Massachusetts, biotech Moderna, with similar technology and results as the one it supported last week by Pfizer and its German collaborator, BioNTech.

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A clinical trial in 30,000 volunteers showed that the Moderna vaccine is more than 94% effective in preventing COVID-19, including serious disease. The vaccine causes frequent side effects like sore arms, fatigue, muscle aches and chills, but all were temporary.

“It’s a very exciting two weeks,” said Barry Bloom, an immunologist at the Harvard T.H. Chan School of Public Health. “To have two companies put forward new vaccines within 11 months and begin to roll them out to the public — that’s an extraordinary both scientific and logistical achievement.”

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Your vaccine questions, answered:I had COVID, should I still get vaccinated? What are the side effects? What are its ‘ingredients?’

Both of these first two vaccines showed similar effectiveness and safety, and are based on mRNA technology, which uses the body’s own process of producing proteins to fight off the virus that causes COVID-19.

The FDA’s Vaccines and Related Biological Products Advisory Committee will meet all day Thursday to discuss the details of the Moderna vaccine and is expected to decide that its benefits outweigh its risks.

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If this independent group gives its OK, the vaccine will go to the FDA commissioner for his approval, likely Friday. An independent advisory committee to the Centers for Disease Control and Prevention is planning this weekend to consider adding the vaccine to the national adult vaccine schedule, and if they sign off, it will go to the CDC director for his approval.

The Moderna vaccine is expected to arrive in states Monday.

Moderna has promised to make 50 million doses of its vaccine available this month, enough to vaccinate 25 million people, largely health care workers and nursing home residents. Alex Azar, the secretary of Health and Human Services, said Wednesday that 5.9 million doses of Moderna’s vaccine are likely to be distributed next week, following 2.9 million doses of Pfizer-BioNTech’s this week.

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Azar also noted that two recent polls showed American attitudes toward COVID-19 vaccination are becoming more positive, with 70% in one poll and 80% in another saying they plan to get vaccinated.

“We still have much work to do to ensure that all Americans understand the value of these safe, effective vaccines,” Azar said. “But it’s clear that many Americans are learning the vaccines are safe and extraordinarily effective.”

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Moderna vaccine trial has limited data for Black, Hispanic people
Moderna data reviewed by the FDA showsits vaccine is equally safe and effective for all subgroups studied, including people who are Black and/or Hispanic, over 65, and for those with health issues such as diabetes.

Several of the VRBPAC members who abstained or voted against the Pfizer-BioNTech vaccine said they voted “no” because they were concerned about allowing its use in 16- and 17-year-olds with only limited safety and effectiveness data in that age group. They said they supported approval in adults.

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