FDA approves Moderna Covid vaccine for emergency use week after Pfizer authorized for Americans

MODERNA'S Covid-19 vaccine was given emergency authorization by the FDA today as thousands continue to receive the Pfizer jab.

The second coronavirus shot received emergency use authorization (EUA) on Friday and doses will be shipped as soon as this weekend, with the first jabs being rolled out by Monday.


Moderna will begin delivering some 20million doses to the US government by the end of the month with 100million and 125million doses available globally in the first quarter of 2021.

Around 85 to 100million of those doses will available in the US early next year for eligible Americans aged 18 or over, the company said.

At 7.47pm ET, Donald Trump tweeted, "Congratulations, the Moderna vaccine is now available!" minutes before the company issued their Twitter confirmation.

Doses will be distributed under his Operation Warp Speed initiative via the Department of Defense, the Department of Health and Human Services (HHS), and Centers for Disease Control and Prevention (CDC).

News of the Moderna's authorization:

  • Shocking pics show blood of Covid patient, 13, sprayed on wall
  • Nurse faints after getting Covid jab but says it's "common" for her
  • Sir Paul McCartney vows to get the coronavirus jab
  • France may be under lockdown for a year despite Covid shot

The CDC's Advisory Committee on Immunization Practices will identify the priority populations and decide where the doses should be shipped to first.

"The Moderna COVID-19 Vaccine has not been approved or licensed by the FDA," the company noted, after announcing the EUA in a statement.

Moderna CEO Stéphane Bancel thanked the clinical trial participants, NIH, NIAID, their partners at BARDA, and praised Trump's Operation Warp Speed initiative.

“I am proud of what the Moderna team has achieved in collaboration with our partners," Bancel said.

"We were able to create and manufacture the Moderna Covid-19 Vaccine in 11 months from sequence to authorization, while advancing clinical development with a Phase 1, Phase 2 and pivotal Phase 3 study of 30,000 participants.



"It has been a 10-year scientific, entrepreneurial and medical journey and I am thankful to all those who have helped us get here today.

"We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease.”

FDA Commissioner Stephen Hahn granted the EUA a week after giving similar clearance to one made by Pfizer and its partner company, BioNTech.

Hahn confirmed that he is "authorizing" rather than approving the vaccine because more research over a longer period of time is needed.

With a full approval pending, health officials believe the benefits of a vaccine outweigh the risk as the United States reported its 17millionth case of Covid-19.

During the clinical trials, Moderna's jab exhibited 94 percent efficacious in protecting people from the deadly disease.

We were able to create and manufacture the Moderna Covid-19 Vaccine in 11 months from sequence to authorization.

The rapid timeline comes after a contract, signed in August, upped the US government's direct financial backing of the Massachusetts-based Moderna to $2.5billion.

The news comes after a third health worker in Alaska had an allergic reaction to the Pfizer vaccine after two others at Bartlett Regional Hospital in Juneau developed symptoms – and one of them was hospitalized.

On Thursday, a Fairbanks staffer received the jab and began experiencing “traditional anaphylactic symptoms," medics said.

All of the workers have since recovered, the Anchorage Daily News reported, and health officials highlighted that allergic reactions are extremely rare.

Earlier on Friday, Trump said that the Moderna vaccine has been "approved" but the FDA initially claimed they are still "rapidly" were working on greenlighting the drug.

The president's tweet read: "Moderna vaccine overwhelmingly approved. Distribution to start immediately."

However, an FDA spokesperson later said the announcement was premature hours before it was confirmed.



LiveSquawk tweeted about 20 minutes after the president, "FDA: Spokesperson: Moderna Covid-19 Vaccine Isn't Yet Authorized Moderna Vaccine EUA Remains Under Review At FDA."

On Thursday night, Hahn said the federal agency is "rapidly" working on finalizing and providing an emergency use authorization (EUA) for its vaccine.

Prior to that statement, a group of external FDA advisers guaranteed a second coronavirus vaccine option by endorsing the emergency use of Moderna's vaccine candidate.

Dr Anthony Fauci predicted that the Moderna Covid-19 vaccine would be distributed by "the very early part of next week."

Speaking on NBC News' TODAY on Friday, the director of the National Institute of Allergy and Infectious Diseases told Savannah Guthrie he hopes the vaccine would be administered by Monday or Tuesday.



"But you know we just have to wait to see for the final decision," he said ahead of Hahn's announcement. "But very soon literally within a few days."

Fauci also admitted that he is "ready" to get vaccinated and will do so "as soon as he can."

The Pfizer vaccine was approved for use by the FDA last week and is available for selected groups across the USA.

Despite the rollout of the Pfizer vaccines, Fauci insisted that the country is still in a "serious situation."

He warned Guthrie that the US still needs "adhere to the public health measures that we're talking about all the time: the wearing of masks the physical distancing the avoiding crowds in congregate settings."

Fauci added: "We can't just say 'well there's vaccine on the horizon, so let's just forget about everything else."

Most read in News

FATHER UNDER FIRE

Dad of missing girl is 'suspect in another cold case' after she vanished

'GRAVE DANGER'

New clue in missing girl case as pic from day she disappeared is revealed

DEAD MAN'S SHOES

My dad's best friend saw him die on a mountain – then married my mum

STORE SLAUGHTER

Moment 'killer who stabbed student, 24, to death' is arrested at bus stop

"We're in a difficult situation so we've got to do both. We've got to proceed with the rollout of the vaccine, but we've got to make sure that we stay with the public health measures."

Meanwhile, Vice President Mike Pence declared “I didn’t feel a thing” after getting the Pfizer Covid vaccine live on TV to boost confidence in the jab.

Pence hailed the "medical miracle" after becoming the highest-ranking member of the US government to receive the vaccine at the White House.

    Source: Read Full Article