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Pfizer and BioNTech start the method of searching for full U.S. approval for his or her Covid vaccine

Pfizer and BioNTech begin the process of seeking full U.S. approval for their Covid vaccine

Vials containing the Pfizer-BioNTech Covid-19 vaccine on Thursday, February 11, 2021 at the vaccination site of the Sun City Anthem Community Center in Henderson, Nevada, USA.

Roger Kisby | Bloomberg | Getty Images

Pfizer and German drug maker BioNTech announced that they have begun filing for full approval of their Covid-19 vaccine for people aged 16 and over in the United States. This makes the companies the first in the nation to apply for full regulatory approval.

The Food and Drug Administration issued emergency approval for their Covid vaccine at the end of December. Since then, Pfizer has distributed 170 million doses in the US, with the goal of having 300 million doses by the end of July.

“We are proud of the tremendous progress we have made in working with the US government to deliver vaccines to millions of Americans since December,” said Albert Bourla, Pfizer CEO, in a statement. “We look forward to working with the FDA to complete this ongoing filing and support its review with the aim of ensuring full regulatory approval for the vaccine in the months ahead.”

Pfizer needs to demonstrate that it can reliably manufacture the vaccines in order to get full clearance. If approved, companies could market their shots directly to consumers and potentially change the pricing of the cans. It also allows the shot to stay in the market once the pandemic is over and the US is no longer considered an “emergency”.

It usually takes the FDA about a year or more to determine whether a drug is safe and effective for the general public. Due to the once in a century pandemic that killed nearly 600,000 people in the United States, the FDA allowed the gunshots to be used as part of an emergency clearance.

The permit grants conditional approval based on data for two months. It’s not the same as a biological license application that requires six months of data and ensures full approval. Companies apply for approval on a “rolling filing” basis, which speeds the review process by allowing the FDA to review new data as soon as the company receives it.

“The BLA filing is an important cornerstone in achieving long-term herd immunity and future COVID-19 containment,” said Dr. Ugur Sahin, CEO and Co-Founder of BioNTech, in a statement. “We are excited to be working with US regulators to apply for approval of our COVID-19 vaccine based on our key Phase 3 study and follow-up data.”

Early data from 12,000 vaccinated people aged 16 and over in this Phase 3 study showed that the shots were 91.3% effective at getting the disease up for up to six months after the second dose and 95.3% effective against severe Covid as defined by the FDA. The companies said on April 1st. The data also showed “a favorable safety and tolerability profile,” they said at the time.

The companies are awaiting FDA emergency approval to use their vaccine in children ages 12-15 and intend to apply for a full license once they have six months of data.

They said in late March that the vaccine was 100% effective in a clinical study involving more than 2,000 adolescents. They also said the vaccine produced a “robust” antibody response in the children that outperformed that in a previous study in older teenagers and young adults. The side effects were generally consistent with those seen in adults, they added.

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BioNTech expects information on youngsters ages 5 to 11 as early as finish of summer season

These colleges now say Covid vaccines will be required for fall 2021

16-year-old Thomas Gregory will be vaccinated with the Pfizer-BioNTech Covid-19 vaccine by Nurse Cindy Lamica at UMass Memorial Health Care’s COVID-19 Vaccination Center at the Mercantile Center in Worcester, Massachusetts on April 22, 2021.

Joseph Precious | AFP | Getty Images

Data on how well the Pfizer-BioNTech Covid-19 vaccine works in children ages 5-11 could be available by the end of this summer, the scientist who helped develop the shot told CNBC.

If clinical trials go well and the Food and Drug Administration approves, young children could be vaccinated by the end of the year, said BioNTech Co-Founder and Chief Medical Officer Dr. Ozlem Tureci, late Thursday.

“We expect the data by the end of summer or fall this year. We will then submit it to the regulatory authorities and, depending on how quickly they react, we will receive approval by the end of the year to also immunize younger children.” ” She said.

In late March, Pfizer and BioNTech began a clinical trial testing their vaccine in healthy children aged 6 months to 11 years. This is a critical step in gaining regulatory approval to vaccinate young children and fight the pandemic.

In the first phase of the study, companies will determine the preferred dosage level for three age groups – between 6 months and 2 years, 2 and 5 years, and between 5 and 11 years. Dosages are assessed 11 first in children ages 5 to 11 before researchers move on to the other age groups, they said.

Since companies rate the older age group first, data on children under 5 could be “a little later,” Tureci told CNBC.

The two-dose vaccine is already approved for use in people aged 16 and over. Earlier this month, Pfizer and BioNTech asked the FDA to allow their Covid-19 vaccine to be given to children ages 12-15 in an emergency.

The companies announced in late March that the vaccine was 100% effective in a study of more than 2,000 adolescents. They also said the vaccine produced a “robust” antibody response in the children that outperformed that in a previous study in older teenagers and young adults. The side effects were generally consistent with those seen in adults, they added.

Vaccinating children is seen as critical to ending the pandemic. The nation is unlikely to achieve herd immunity – if enough people in a given community have antibodies to a given disease – until children can be vaccinated, health officials and experts say.

According to the government, children make up around 20% of the total US population. According to experts, between 70% and 85% of the US population must be vaccinated against Covid to achieve herd immunity and some adults may refuse to get the shots.

In addition to testing the vaccine in young children, Pfizer and BioNTech are testing whether a third dose of the vaccine would provide a better immune response against new variants of the virus.

Ugur Sahin, CEO of BioNTech, told CNBC on Thursday that he was “confident” that the vaccine would be effective against B.1.617, a highly contagious variant of coronavirus first identified in India.

Still, he said, people will likely need a third shot of his two-dose vaccine as immunity to the virus wanes. Researchers see a decrease in antibody responses to the virus after eight months, he added.

“If we give a boost, we could actually increase the antibody response beyond what we started with, and that could give us a real comfort of protection for at least 12 months, maybe 18 months,” said Sahin. “And that is really important at a time when all variants are coming.”

Sahin also said he anticipates demand for the shot will continue to rise, adding that the company will increase production capacity of the vaccine to 3 billion doses by the end of 2021. In December, Sahin expects the company’s production target to increase to 400 million cans per month.

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BioNTech CEO assured shot works in opposition to India pressure

BioNTech CEO confident shot works against India strain

Ugur Sahin, CEO of BioNTech, told CNBC on Thursday that he was “confident” that the company’s Covid-19 vaccine with US partner Pfizer will be effective against a variant of the coronavirus first identified in India.

The strain known as B.1.617 contains two key mutations that have been found separately in other coronavirus variants. The variant, also known as the “double mutant,” was first discovered in India, where some believe it is behind a recent spike in new Covid-19 cases.

The variant has since been identified in other countries, including the United States.

Sahin said the German drug maker had tested its two-dose vaccine, currently not available in India, against similar “double mutants”. Based on that data, Sahin said he feels confident the shot will still be protective.

“We evaluate [the strain] … and the data will be available in the coming weeks, “he told CNBC.

“However, we had similar double mutants in our previous tests and are confident from the data we had in the past that we could see a similar way of neutralizing this virus. But we will only know when we have the data in our hands, “he added.

In recent months, US health officials have said they fear that new, highly contagious variants of the virus may one day be able to evade the protection of currently approved vaccines. They urge Americans to get vaccinated as soon as possible before new and potentially more dangerous variants emerge.

Studies have shown that the Pfizer BioNTech vaccine still protects against other strains, including B.1.526, the variant first identified in New York, and B.1.1.7, the variant found in the UK

An Israeli study found that B.1.351, the variant discovered in South Africa, was able to bypass some of the protection provided by the Pfizer BioNTech vaccine, even though the shot continued to be highly effective.

Although the shot continues to be effective, Sahin said people will likely need a third shot of his two-dose Covid-19 vaccine to reduce immunity to the Tureci virus.

In February, Pfizer and BioNTech announced that they were testing a third dose of their Covid-19 vaccine to better understand the immune response against new variants of the virus.

Sahin said Thursday that researchers are seeing a decrease in antibody responses to the virus after eight months.

“If we give a boost, we could actually increase the antibody response beyond what we started with, and that could give us real comfort in protection for at least 12 months, maybe 18 months,” he said.

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Fosun Pharma falls as Hong Kong suspends BioNTech Covid vaccinations

Fosun Pharma falls as Hong Kong suspends BioNTech Covid vaccinations

Vaccination program branding on the clothing of a staff member outside a community vaccination center administering the BioNTech Covid-19 vaccine imported by Fosun Pharma on Wednesday March 17, 2021 in Hong Kong, China.

Chan Long Hei | Bloomberg via Getty Images

Shares in China’s Shanghai Fosun Pharmaceutical Group fell after Hong Kong and Macau announced on Wednesday that they would suspend vaccinations for BioNTech Covid.

Fosun Pharma, BioNTech’s partner in the development and distribution of the Comirnaty Covid-19 vaccine in Greater China, has informed the cities of a packaging error in batch 210102 of the vaccine.

Hong Kong and Macau said they would suspend vaccinations made in Germany as a precaution.

The cities said BioNTech and Fosun Pharma are investigating the cause of the vial cap failure, adding that there is currently no reason to doubt the vaccine’s safety.

Macau says all of its messenger RNA or mRNA vaccines belong to the affected batch. Hong Kong said it would also temporarily suspend vaccinations from batch 210104 until the investigation is completed.

Hong Kong-listed Fosun Pharma shares fell 4.83% in the city on Wednesday afternoon.

Hong Kong approved the BioNTech emergency vaccine in January, while Macau gave the vaccine a special import permit in late February. Both areas received their first shots in late February.

BioNTech’s mRNA-based vaccine has a proven efficacy of 95% in adults, according to data from its global Phase 3 clinical trial. Real-world data has shown that Pfizer-BioNTech’s two-dose Covid vaccine delivers “very strong” results after just one shot.

The news comes as countries around the world struggle to vaccinate their populations amid rising Covid cases in most regions.

More than 124 million infections have been reported worldwide and the death toll from Covid has exceeded 2.7 million, according to Johns Hopkins University.

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BioNTech CEO says vaccine is efficient towards new strains

BioNTech CEO says vaccine is effective against new strains

The CEO of German pharmaceutical company BioNTech remains confident that the company’s Covid vaccine, developed in partnership with Pfizer, will be effective against the highly infectious variants of the virus discovered in the UK and South Africa.

“We are confident that based on the mechanism of our vaccine, although there are mutations, we believe that the immune response induced by our vaccine could also treat (a) mutated virus,” said Dr. Ugur Sahin, co-founder and CEO of BioNTech, said CNBC’s Meg Tirrell on Monday.

“Last week we reported another mutation that is present in both the UK and South African variants. This mutation is believed to be important as it could structurally alter the protein. However, it appears that the immune response to our vaccine does also neutralizes mutation. “

His comments were based on research published Thursday showing that Pfizer-BioNTech’s Covid-19 vaccine appeared to be effective against a key mutation in the more infectious variants of the virus discovered in the UK and South Africa.

The study, carried out by US pharmaceutical giant Pfizer and not yet peer-reviewed, suggested that the vaccine neutralized the so-called N501Y mutation. This mutation has been reported in the coronavirus variants discovered in the UK and South Africa.

The variants, which emerged separately, both share a genetic mutation of the so-called spike protein, which the virus uses to penetrate the cells of the body.

Doctors tentatively welcomed the results of the study last week, but cautioned that the research focused only on the N501Y mutation found in both new variants.

BioNTech’s Sahin said the company will be able to present more data in the coming days examining the full set of mutations.

The new vaccine could be ready “within six weeks”.

Pfizer-BioNTech’s Covid vaccine uses messenger RNA or mRNA technology, like Moderna’s. In practice, the US Centers for Disease Control and Prevention says this “teaches our cells how to make a protein – or even a piece of a protein – that will trigger an immune response in our bodies.”

The resulting immune response produces antibodies that protect people from becoming infected with the virus.

Ugur Sahin, co-founder and CEO of Biontech, is on the company premises. Biontech is a biotechnology company that researches vaccines against the coronavirus, among other things. (Photo by Andreas Arnold / Image Alliance via Getty Images)

Andreas Arnold | Image alliance via Getty Images

When asked how fast BioNTech could turn if the existing Covid vaccine were found to be ineffective against new variants, Sahin said “a key benefit” of mRNA technology is that the company is adapting the vaccine relatively quickly could. “”

“We can change the order of the vaccine in a matter of days and, in principle, deliver a new vaccine within six weeks. This is technically possible and if necessary we would go for it,” he said, noting that it is is would also require discussions with regulators such as the Food and Drug Administration.

“We are therefore confident that the technology with which we can react to a mutation or a virus variant with different problems will react extremely quickly,” said Sahin.

Public health experts have raised concerns that the new mutant strains could pose a threat to vaccination efforts. In recent weeks, optimism about the mass adoption of Covid vaccines has been tempered by the resurgent rate of virus spread around the world.

To date, more than 90.3 million people worldwide have contracted the coronavirus, with 1.93 million deaths, according to data from Johns Hopkins University.