Home Tags Posts tagged with "fda emergency authorization"

fda emergency authorization

0

The US mass vaccination will begin on December 14 after it was authorized for emergency use, officials say.

The first three million doses of the Pfizer/BioNTech coronavirus vaccine would be shipped “across all states” this weekend, said General Gustave Perna, who is overseeing distribution.

The vaccine offers up to 95% protection against Covid-19 and was deemed safe by the FDA.

On December 12, the US recorded a daily toll of 3,309 Covid-related deaths.

The figure, reported on the Johns Hopkins University website, is the highest total in a single day anywhere in the world.Coronavirus deaths have been rising sharply since November in the US.

Joe Biden Sets 100M Covid Vaccinations Goal for First 100 Days

Pfizer Coronavirus Vaccine Approved in UK

Pfizer Vaccine Appears to Protect 94% of Adults over 65 Years Old

Authorizing the emergency use of the Pfizer/BioNTech vaccine on December 11, the FDA – which had come under intense pressure from the Trump administration to do so – said the move was a “significant milestone” in the pandemic.

During a news conference on December 12, Gen. Perna – speaking for the government’s vaccination campaign Operation Warp Speed – said doses of the vaccine would be packed into shipping containers for transportation “within the next 24 hours”.

He said: “Expect 145 sites across the states to receive the vaccine on Monday, another 425 sites on Tuesday, and the final 66 sites on Wednesday.”

He also said that next week’s distribution would complete the initial delivery of the Pfizer/BioNTech vaccine and cover about three million people.

Gen. Perna told reporters he was “100% confident” that the doses “needed to defeat the enemy Covid” would be transported safely.

However, he warned that while it had been a week of progress, “we are not done until every American has access to a vaccine”.

The Pfizer vaccine has already received regulatory approval in the UK, Canada, Bahrain and Saudi Arabia. Like those countries, US health authorities are expected to prioritize health workers and care home residents for the first doses.

More Americans outside the highest-priority groups are likely to be able to get the vaccine in January, with general availability expected by April.

On December 10, medical experts advising the FDA recommended the emergency-use authorization. A 23-member panel concluded the vaccine’s benefits outweighed its risks.

Emergency use, the FDA said, was not the same as full approval, which would require Pfizer to file a separate application to secure.

The Pfizer/BioNTech product was the first coronavirus vaccine to show promising results in the latter stages of its testing process.

It is a new type called an mRNA vaccine that uses a tiny fragment of genetic code from the pandemic virus to teach the body how to fight Covid-19 and build immunity.

The FDA said: “The vaccine contains a small piece of the [Covid-19] virus’s mRNA that instructs cells in the body to make the virus’s distinctive ‘spike’ protein.”

Pfizer and BioNTech are filing for emergency authorization in the US of their Covid-19 vaccine on Friday, November 20.

The FDA will decide if the vaccine is safe to roll out.

It is not clear how long the FDA will take to study the data. However, the US government expects to approve the vaccine in the first half of December.

Data from an advanced trial showed the vaccine protects 94% of adults over 65.

Pfizer’s and BioNTech’s trial involved 41,000 people worldwide. Half were given the vaccine, and half a placebo.

If FDA authorization does come in the first half of next month, Pfizer and BioNTech will “be ready to distribute the vaccine candidate within hours”, the two companies said.

This would be remarkably quick for vaccine development – within 10 months of detailing the genetic code. The average wait for approval in the US is nearer eight years.

On November 19, Pfizer CEO Albert Bourla said that the filing for emergency use was a “milestone in our journey to deliver a Covid-19 vaccine to the world”.

Initial doses would be scarce, though, and the Centers for Disease Control and Prevention (CDCP) will decide who is first in line.

European Commission president Ursula von der Leyen said the EU could move quickly too – by the end of the year.

Pfizer Vaccine Appears to Protect 94% of Adults over 65 Years Old

Moderna Vaccine Shows Nearly 95% Protection Against Covid-19

Coronavirus: Pfizer Vaccine Offers 90% Protection

Data released this week suggested the Pfizer and BioNTech vaccine had 95% effectiveness.

This effectiveness was also consistent across age groups – essential given the vulnerability of the elderly – as well as ethnicities and gender.

The vaccine also had only mild-to-moderate and short-lived side-effects.

It uses an experimental approach, called mRNA, which involves injecting part of the virus’s genetic code into the body to train the immune system.

Antibodies and T-cells are then made by the body to fight the coronavirus.

The US this week passed 250,000 deaths in the coronavirus outbreak, by far the largest number in the world.

Its confirmed cases since the pandemic began stand at 11.7 million, according to Johns Hopkins University research, again a global first.

Cases have also been soaring over the past week, reaching record daily highs.