Covid vaccine: Pfizer applies for first approval in US

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  • Coronavirus pandemic

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Pfizer and its partner BioNTech apply for emergency approval for their Covid-19 vaccine in the US on Friday.

It will be up to the US Food and Drug Administration (FDA) to decide whether the vaccine can be safely imported.

It’s not clear how long it will take the FDA to investigate the data. However, the US government expects the vaccine to be approved in the first half of December.

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

41,000 people worldwide were involved in the process. Half received the vaccine and half received a placebo.

The UK has pre-ordered 40 million cans and should receive 10 million by the end of the year.

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So when can we expect vaccinations?

If FDA approval occurs in the first half of next month, Pfizer and BioNTech will “be ready to sell the vaccine candidate within hours,” the two companies said.

This would be remarkably fast for vaccine development – within 10 months of detailing the genetic code. The average waiting time for approval in the US is nearly eight years.

Albert Bourla, CEO of Pfizer, said Thursday the emergency filing was a “milestone in our journey to deliver a Covid-19 vaccine to the world”.

Starting doses would be tight, however, and the Centers for Disease Control and Prevention (CDCP) will decide who comes first.

Media signatureCoronavirus Vaccine: How Close Are You To One?

The President of the European Commission, Ursula von der Leyen, said that the EU could act quickly – by the end of the year.

But there are reservations. Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said both the FDA and the European Medicines Agency (EMA) are “doing a very careful assessment”.

And BBC health correspondent Naomi Grimley says this vaccine is still far from widespread use, not least because it uses experimental technology that has never been approved before.

How effective is it?

The data released this week suggest the Pfizer and BioNTech vaccine have 95% effectiveness.

This effectiveness was also the same in all age groups – given the vulnerability of older people – as well as in terms of race 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’ genetic code into the body to train the immune system.

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

How is the Covid situation in the USA?

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

The confirmed cases since the pandemic began totaling 11.7 million, according to research by Johns Hopkins University, which is a world first.

In the past week, cases have also risen sharply and reached record highs.

Image rightsReutersImage descriptionA nurse and patient in Burbank, California. The health system is tense in many areas of the United States

The health system is struggling to cope with the creation of makeshift wards in many areas.

The CDCP has issued a “strong recommendation” that Americans should not travel during the Thanksgiving holiday.

In California, there will be a curfew from 10:00 p.m. to 5:00 a.m. starting Saturday for the vast majority of the population.

Ohio, Minnesota, and New York are among other states that impose severe restrictions.

The transition of administrations did not help either. President-elect Joe Biden complained about the lack of cooperation from Donald Trump’s administration.

What other vaccines are being developed?

Data on a vaccine from the US company Moderna also indicate protection of almost 95%. The mRNA approach is also used here.

In terms of development, it’s believed to be not far behind the Pfizer / BioNTech vaccine.

An Oxford University / AstraZeneca vaccine is still in testing but has shown promising results with a strong immune response in the elderly. Britain has ordered 100 million cans.

It is made from a weakened version of a chimpanzee cold virus that has been modified so that it does not grow in humans.

There are similarly promising results from trials with another vaccine developed in Russia called Sputnik. It works like the Oxford vaccine.

Other vaccines are in late-stage testing in China and Russia.

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