Pfizer’s two-dose Covid-19 vaccine has received full approval from the US Food and Drug Administration (FDA) – the first jab to be licensed in the nation.

The vaccine had initially been given emergency use authorisation. Its two jabs, three weeks apart, are now fully approved for those aged 16 and older.

The approval is expected to set off more vaccine mandates by employers and organisations across the country.

It comes amid lingering vaccine hesitancy among many Americans.

In a statement, the FDA said its review for approval included data from approximately 44,000 people. The vaccine, which will now be marketed as Comirnaty, was found to be 91% effective in preventing Covid disease.

Acting FDA commissioner Janet Woodcock said that the public « can be very confident » the vaccine meets high safety, effectiveness and manufacturing quality standards.

It still has emergency use authorisation for children aged 12 to 15.

The jabs are being provided at no cost to Americans.

The FDA initially gave Pfizer temporary authorisation – a clearance given if the agency determines the benefits of a product outweigh potential risks during a public health emergency.

This full approval is essentially permanent. The licensing process requires companies to provide the FDA with information on how and where the product is made, as well as other clinical testing data.

Critics had been calling on the FDA to speed up this approval process as the nation struggled with dropping vaccination rates earlier this year. The spread of the contagious Delta variant has already given some hard-hit regions a bump in vaccination rates in recent weeks.

While the agency took steps to increase staff and resources, it had previously said it would take six months to get the required data.

The approval ultimately came less than four months after Pfizer-BioNTech filed for licensing in early May – the fastest vaccine approval in the FDA’s more than 100 year history.

Polling data released at the end of June by the Kaiser Family Foundation found that about 30% of unvaccinated American results said they would be more likely to get a vaccine if it received full FDA approval. The number rises to nearly 50% among Americans taking a « wait and see » approach to vaccines.

In a televised address on Monday, President Biden spoke directly to the « millions » of Americans he said were waiting for full and final FDA approval.

« The moment you’ve been waiting for is here, » he said. « It’s time for you to go get your vaccination. Get it today. »

Additionally, Mr Biden called on private sector companies and nonprofits to require employees to get vaccinated or « face strict requirements ».

Companies, healthcare systems, universities and other organisations are now expected to announce vaccine requirements as the country embarks on a return to normalcy. The US military has also said the vaccine will become mandatory for 1.3 million active-duty troops upon FDA approval.

To date, more than 92 million vaccinated Americans – more than half of the total – have received the Pfizer vaccine.

World Opinions – bbc

L’article Pfizer becomes first Covid vaccine to gain full FDA approval est apparu en premier sur World Opinion | Alternative Média.

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.

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.

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.

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.

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.

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

World Opinions News – bbc.com

L’article Moderna vaccine safe and effective, say US experts est apparu en premier sur World Opinion | Alternative Média.

The results are in for a forerunner in the race for a COVID-19 vaccine.

United States pharma giant Pfizer Inc and its German partner BioNTech said on Wednesday that final results from the Phase 3 trial of their COVID-19 vaccine showed it to be 95 percent effective – the highest success rate for any pandemic candidate in late-stage trials so far.

The drug companies will now submit an application with the US Food and Drug Administration for Emergency Use Authorization (EUA) “within days” and to share trial data with other regulatory agencies around the globe, said Pfizer.

“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” said Pfizer chief Albert Bourla in a statement. “We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world.”

Before the FDA authorises any COVID-19 vaccine for emergency use, officials will review and discuss the trial data in a public meeting likely to take place next month, said Pfizer.

Pfizer and BioNTech expect to produce up to 50 million vaccine doses globally this year and as many as 1.3 billion doses by the end of 2021.

If the FDA grants emergency use, it will still be months before the vaccine is widely available. Governments though are expected to give priority to groups such as front-line healthcare workers and immunocompromised individuals to receive the vaccine this year.

The Pfizer-BioNTech late-stage trial involved nearly 44,000 volunteers, of which 42 percent globally and 30 percent in the US had diverse backgrounds.

The results showed the vaccine to be consistently effective across people of different ages, races and ethnicities. For people above 65, the vaccine was shown to be 94 percent effective, said Pfizer.

Some 170 infections were observed in the study, eight of which were observed in people who received the vaccine rather than a placebo. One of those eight who received the vaccine developed a severe case of COVID-19.

The trial will continue to collect data on efficacy and safety for two more years.

Wednesday’s announcement comes a week after initial results from the trial showed the vaccine was more than 90 percent effective and days after Moderna Inc released promising preliminary trial data for its COVID-19 vaccine that showed it be 94.5 percent effective.

Neither Pfizer-BioNTech nor Moderna’s vaccines are made with the coronavirus. Instead, they were developed with new messenger RNA (mRNA) technology that relays genetic instructions to teach the human immune system – how to make virus-slaying antibodies.

Logistical concerns have been raised about distribution of the Pfizer-BioNTech vaccine because it needs to be stored in ultracold temperatures of -70 degrees Celcius (-94 degrees Fahrenheit).

The companies sought to assuage those concerns, saying they have developed speciality temperature-controlled thermal shippers that can be used as temporary storage units for 15 days by refilling them with dry ice.

“We have confidence in our vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world,” said Pfizer.

The better than expected results from late-stage trials of Pfizer-BioNTech’s vaccine as well as Moderna’s have ignited hopes that a gamechanger is within grasp to conquer a pandemic that has claimed more than 1.3 million lives around the world, decimated the global economy, obliterated livelihoods, and exacerbated inequalities between and within nations.

Pfizer’s final results come as new infections are raging across the world, with surges of new cases straining healthcare systems that are dealing with record spikes in hospitalisations.PUBLICITÉ

Dozens of drug companies and research groups are working to develop a safe and effective vaccine against COVID-19.

SOURCE : AL JAZEERA

L’article Pfizer ends COVID-19 vaccine trial with 95% success rate est apparu en premier sur World Opinion | Alternative Média.