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Pfizer tries to avoid taxes worldwide, through the Netherlands. : worldnews From “World News”



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CDC advisers mull how to use Pfizer shots in kids 12 and up From “World News Headlines, Latest International News, World Breaking News – Times of India”



States are rolling out Pfizer’s Covid-19 shots to pediatricians and even some school vaccine clinics as they prepare to vaccinate millions of kids as young as 12. AP PhotoStates are rolling out Pfizer’s Covid-19 shots to pediatricians and even some school vaccine clinics as they prepare to vaccinate millions of kids as young as 12. Federal health advisers were meeting Wednesday to issue recommendations on how to vaccinate those 12 to 15 years old with the shot. Earlier in the week, the Food and Drug Administration cleared expanded use of Pfizer’s shots, citing evidence they worked as well for the younger age group as for those 16 and older. While kids in some places already are rolling up their sleeves, much of the nation is awaiting the recommendations from advisers to the Centers for Disease Control and Prevention. Among the outstanding questions: Is it OK to get vaccinated against Covid-19 at the same doctor’s visit as kids receive some routine vaccinations, such as the HPV shot? Doctors who are ready to vaccinate their own kids want other parents to line up, too. “Their lives have been really disrupted by this virus,” said Dr. Anne Zink, Alaska’s chief medical officer and president-elect of the Association of State and Territorial Health Officials. Zink described how her already vaccinated 16-year-old loves hanging out with unmasked friends while “my 13-year-old pouted away and said, ‘I can’t wait for mine'” — shortly before learning she will get a turn, too. The FDA on Monday authorized use of Pfizer’s vaccine in younger teens after a study of more than 2,000 12- to 15-year-olds found it offers strong protection. There were no cases of Covid-19 among volunteers given the two-shot vaccination compared with 16 in the group given dummy shots. Kids got the same dose as adults but developed even higher levels of virus-fighting antibodies. Side effects are the same as adults experience, mostly sore arms and flu-like fever, chills or aches that signal the immune system is revving up. But not surprisingly they were a little more common in the kids. Headache, for example, occurred in half of people 16 and older but in three-quarters of the younger teens in Pfizer’s studies. Vaccinating Americans of all ages will be critical to getting back to normal, and there’s plenty of supply for the nation’s nearly 17 million 12- to 15-year-olds. In addition to the mass vaccination sites and health department rollouts that were key for adults, many states will be offering kids more familiar options — shipping doses to pediatricians and even to schools. In Alaska, for example, Zink said some schools were set to hold vaccination clinics in cafeterias in the coming days. Pfizer is not the only company seeking to lower the age limit for its vaccine. Moderna recently said preliminary results from its study in 12- to 17-year-olds show strong protection and no serious side effects, data the FDA will need to scrutinize. As for even younger children, both companies have begun tests in youngsters ages 6 months to 11 years. Those studies explore if different doses are needed at the youngest ages, and FDA plans to hold a public meeting next month to debate exactly what evidence is needed. FacebookTwitterLinkedinEMail







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Pfizer scientist on mRNA and ‘more potent’ flu shots From “International: Top News And Analysis”



Kathrin Jansen, Pfizer Inc, poses for a portrait in one of her labs in Pearl River, New York.Carlo Allegri | ReutersThe mRNA technology used to develop the Pfizer-BioNTech Covid-19 vaccine could also help create “more potent” seasonal flu shots, Kathrin Jansen, head of Pfizer’s vaccine research and development, told CNBC.How well flu vaccines work can vary from season to season. But generally, flu inoculations reduce the risk of illness from influenza viruses by between 40% and 60%, according to the Centers for Disease Control and Prevention.Jansen said the reason why flu vaccine effectiveness varies is due to the fact that influenza viruses are always changing and a strain that was common in a previous season may not be as prevalent in the next. Scientists have to constantly monitor strains and select which ones will be included in the flu vaccine each year.Sometimes scientists make selections that don’t match well, Jansen said. But with the flexibility of mRNA technology, scientists could quickly “pivot” and adjust the flu vaccine to match the more dominant strain, she said.”I think the great success of the mRNA vaccines in addressing Covid-19 has clearly opened up a large number of possibilities,” Jansen said in comments that aired Tuesday during CNBC’s Healthy Returns Summit.”We want to have better vaccines for older individuals” who are at risk for severe disease, she said in the interview with CNBC’s Meg Tirrell. “This is in my mind a very powerful approach to get us to ultimately more potent seasonal influenza vaccines.”Jansen’s comments come after Pfizer had huge success with its mRNA-based Covid-19 vaccine.Messenger RNA, or mRNA, technology has been under development for years, but Pfizer’s and Moderna’s Covid-19 vaccines are the first time mRNA has been cleared for use in humans. The mRNA-based Covid vaccine works by tricking the body to produce a harmless piece of the virus, triggering an immune response. It’s said to be easier to produce over traditional vaccines, which generally use a dead or weakened virus to produce an immune response.Pfizer and its German partner BioNTech announced plans to develop a coronavirus vaccine in March of last year and submitted an application to the Food and Drug Administration for emergency use authorization in November.The two-dose vaccine, given three weeks apart, was found in a clinical trial to be about 95% effective.In releasing its first-quarter earnings report last week, Pfizer said it expects full-year sales of $26 billion from the vaccine, up from its previous forecast of about $15 billion. It expects an adjusted pretax profit in the high 20% range of revenue for the vaccine.Pfizer executives told investors that they also hope to make improvements over current flu vaccines. They said given the strong immune response for the Covid-19 vaccine, they hope it will be the same for an mRNA-based flu vaccine. Rival Moderna is also working on a flu vaccine using mRNA technology.Stay connected with Healthy ReturnsFor a front row seat at CNBC Events, you can hear directly from the visionary executives, innovators, leaders and influencers taking the stage in “The Keynote Podcast.” Listen now, however you get your podcasts.For more exclusive insights from our reporters and speakers, sign up for our Healthy Returns newsletter to get the latest delivered straight to your inbox weekly.







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Coronavirus live news: India variant ‘of concern’ globally, says WHO; Pfizer vaccine approved for US 12-15-year-olds | World news From “World news | The Guardian”


6.25am BST
06:25

Singapore’s prime minister, Lee Hsien Loong, has condemned an alleged racist attack on a local woman of Indian descent after she was reportedly kicked and abused for not wearing a mask, in a case that is being investigated by police, Reuters has reported.
In a Facebook post on Monday night, Lee said anxiety and stress caused by the pandemic “does not justify racist attitudes and actions, much less physically abusing and assaulting someone because she belongs to a particular race, in this case Indian.”
Local media reported the 55-year-old Singaporean woman was walking briskly on Friday when a man shouted racial slurs at her for not wearing her mask above her nose and kicked her in the chest.
Face masks are mandatory in public in Singapore, but can be removed when exercising, including brisk walking.

6.22am BST
06:22

The World Health Organization has said the B.1.617 variant spreading in India shows signs of being more transmissible, and is now being treated as a variant of concern globally.
The WHO’s Covid-19 chief, Maria Van Kerkhove, said they were studying the data out of India “very, very carefully” and would provide more details in the weekly epidemiological update on Tuesday.
Here she speaks more about the issue:

Maria Van Kerkhove
(@mvankerkhove)
The #SARSCoV2 virus variant B.1.617 is currently listed as a variant of interest but is being evaluated as a potential variant of concern by @WHO & our 🦠 evolution working groupWe are grateful for the ongoing work around 🌍 to monitor & study VOI/VOC#COVID19 @WHO @DrTedros pic.twitter.com/CUDd4ue1ZW

May 9, 2021

The move – an upgrade from classification as a “variant of interest” – means the variant will be added to the list that contains others such as those first detected in UK (B.1.1.7), Brazil (P.1) and South Africa (B.1.351).
India, suffering from one of the worst outbreaks in the world, reported nearly 370,000 fresh infections and more than 3,700 new deaths on Monday. The devastating wave has overwhelmed India’s healthcare system, and experts have said official figures for cases and fatalities are much lower than the actual numbers.
BioNTech on Monday sought to ally concerns about the mutation in India, saying that “to date, there is no evidence” that the jab needs to be adapted to fight the emerging variants.

6.15am BST
06:15

Summary

Hello and welcome to today’s coronavirus liveblog, where you can find the latest developments and data from around the world on the pandemic. Below are a few points to catch up on:

The World Health Organization has said the B.1.617 variant spreading in India shows signs of being more transmissible, and is now being treated as a variant of concern globally.
US health authorities have approved the Pfizer/BioNTech vaccine for emergency use in adolescents. US regulators authorised the Pfizer/BioNTech Covid-19 vaccine for use in children as young as 12.
Malaysia’s government has announced that it will impose a national lockdown in response to rising cases. All social gatherings will be banned and schools closed.
WHO chief Tedros Adhanom Ghebreyesus said that public health capacities must be strengthened to prepare for the possibility of vaccine-evading Covid-19 variants.
France records its’ lowest case figures of 2021. The country records 3,292 new Covid-19 cases and 292 deaths.
University students at the State University of New York (SUNY) and the City University of New York (CUNY) must get vaccinated against Covid-19 to attend classes during the fall semester.
The French prime minister Jean Castex has said that France was “emerging on a long-term basis” from the Covid-19 crisis.
Argentina’s health ministry confirmed its first cases of the Covid-19 variants first discovered in India and South Africa in three travellers returning from Europe.
Novavax Inc has said the development of its Covid-19 vaccine is slower than previously anticipated and does expect to file for regulatory approval until the third quarter of 2021.









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Pfizer COVID-19 shot expanded to US children as young as 12 From “Yahoo News – Latest News & Headlines”



U.S. regulators on Monday expanded the use of Pfizer’s COVID-19 vaccine to children as young as 12, offering a way to protect the nation’s adolescents before they head back to school in the fall and paving the way for them to return to more normal activities.Shots could begin as soon as Thursday, after a federal vaccine advisory committee issues recommendations for using the two-dose vaccine in 12- to 15-year-olds. An announcement is expected Wednesday.Most COVID-19 vaccines worldwide have been authorized for adults. Pfizer’s vaccine is being used in multiple countries for teens as young as 16, and Canada recently became the first to expand use to 12 and up. Parents, school administrators and public health officials elsewhere have eagerly awaited approval for the shot to be made available to more kids.“This is a watershed moment in our ability to fight back the COVID-19 pandemic,” Dr. Bill Gruber, a Pfizer senior vice president who’s also a pediatrician, told The Associated Press.The Food and Drug Administration declared that the Pfizer vaccine is safe and offers strong protection for younger teens based on testing of more than 2,000 U.S. volunteers ages 12 to 15. The agency noted there were no cases of COVID-19 among fully vaccinated adolescents compared with 16 among kids given dummy shots. More intriguing, researchers found the kids developed higher levels of virus-fighting antibodies than earlier studies measured in young adults.The younger teens received the same vaccine dosage as adults and had the same side effects, mostly sore arms and flu-like fever, chills or aches that signal a revved-up immune system, especially after the second dose.Pfizer’s testing in adolescents “met our rigorous standards,” FDA vaccine chief Dr. Peter Marks said. “Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic.”Pfizer and its German partner BioNTech recently requested similar authorization in the European Union, with other countries to follow.Story continuesThe latest news is welcome for U.S. families struggling to decide what activities are safe to resume when the youngest family members remain unvaccinated.“I can’t feel totally comfortable because my boys aren’t vaccinated,” said Carrie Vittitoe, a substitute teacher and freelance writer in Louisville, Kentucky, who is fully vaccinated, as are her husband and 17-year-old daughter.The FDA decision means her 13-year-old son soon could be eligible, leaving only her 11-year-old son unvaccinated. The family has not yet resumed going to church, and summer vacation will be a road trip so they do not have to get on a plane.“We can’t really go back to normal because two-fifths of our family don’t have protection,” Vittitoe said.President Joe Biden said Monday’s decision marked another important step in the nation’s march back to regular life.“The light at the end of the tunnel is growing, and today it got a little brighter,” Biden said in a statement.Pfizer is not the only company seeking to lower the age limit for its vaccine. Moderna recently said preliminary results from its study in 12- to 17-year-olds show strong protection and no serious side effects. Another U.S. company, Novavax, has a COVID-19 vaccine in late-stage development and just began a study in 12- to 17-year-olds.Next up is testing whether the vaccine works for even younger children. Both Pfizer and Moderna have begun U.S. studies in children ages 6 months to 11 years. Those studies explore whether babies, preschoolers and elementary-age kids will need different doses than teens and adults. Gruber said Pfizer expects its first results in the fall.Outside of the U.S., AstraZeneca is studying its vaccine among 6- to 17-year-olds in Britain. And in China, Sinovac recently announced that it has submitted preliminary data to Chinese regulators showing its vaccine is safe in children as young as 3.Children are far less likely than adults to get seriously ill from COVID-19, yet they represent nearly 14% of the nation’s coronavirus cases. At least 296 have died from COVID-19 in the U.S. alone, and more than 15,000 have been hospitalized, according to a tally by the American Academy of Pediatrics.That’s not counting the toll of family members becoming ill or dying — or the disruption to school, sports and other activities so crucial to children’s overall well-being.The AAP welcomed the FDA’s decision.“Our youngest generations have shouldered heavy burdens over the past year, and the vaccine is a hopeful sign that they will be able to begin to experience all the activities that are so important for their health and development,” said AAP President Dr. Lee Savio Beers in a statement.Experts say children must get the shots if the country is to vaccinate the 70% to 85% of the population necessary to reach what’s called herd immunity.In the meantime, the Centers for Disease Control and Prevention says unvaccinated people — including children — should continue taking precautions such as wearing masks indoors and keeping their distance from other unvaccinated people outside of their households.___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.







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Pfizer COVID jab expanded to US children as young as 12 | Coronavirus pandemic News From “Al Jazeera – Breaking News, World News and Video from Al Jazeera”



Coronavirus vaccines will be made available to more children in the United States as regulators on Monday expanded use of the Pfizer-BioNTech jab to those as young as 12, sparking a race to protect students before they head back to class later this year.
Shots could begin as soon as Thursday, after a federal vaccine advisory committee issues recommendations for using the two-dose vaccine in 12- to 15-year-olds. An announcement is expected Wednesday.
Most COVID-19 vaccines worldwide have been authorised for adults. Pfizer’s vaccine is being used in multiple countries for teens as young as 16, and Canada recently became the first to expand use to 12 and up.
Parents, school administrators and public health officials elsewhere have eagerly awaited approval for the shot to be made available to more children.
US President Joe Biden issued a statement hailing the authorisation as “a promising development in our fight against the virus”.
“If you are a parent who wants to protect your child, or a teenager who is interested in getting vaccinated, today’s decision is a step closer to that goal,” he said.
Most children with COVID-19 only develop mild symptoms or no symptoms at all. However, children are not without risk of becoming seriously ill, and they can still spread the virus. There have been outbreaks traced to sporting events and other activities for children aged between 12 and 15.
Dr William Gruber, a top vaccine scientist at Pfizer, said the authorisation of the vaccine for young teens would help the US expand its immune population and protect an age group that has not been completely spared from severe disease.
“I hear from pediatricians and people out in the community, what a godsend this is going to be for the adolescent population who have been restricted in terms of sports activities, drama club and the other sorts of things that naturally we want them to engage in,” Gruber said.
“This is a watershed moment in our ability to fight back the COVID-19 pandemic.”
Vaccinating children of all ages will be critical to a return to normalcy.
The US Food and Drug Administration (FDA) declared the Pfizer vaccine is safe and offers strong protection for younger teens based on testing of more than 2,000 volunteers ages 12 to 15.

WATCH LIVE at 7pm ET: Join Acting FDA Commissioner @DrWoodcockFDA and @FDACBER Director Dr. Peter Marks as they discuss Pfizer-BioNTech’s #COVID19 vaccine for use in adolescents 12-15 years of age. https://t.co/PDF95M3LX7
— U.S. FDA (@US_FDA) May 10, 2021

The study found no cases of COVID-19 among fully vaccinated adolescents compared with 18 among kids given dummy shots. More intriguing, researchers found the kids developed higher levels of virus-fighting antibodies than earlier studies measured in young adults.
The younger teens received the same vaccine dosage as adults and had the same side effects, mostly sore arms and flu-like fever, chills or aches that signal a revved-up immune system, especially after the second dose.
Pfizer’s testing in adolescents “met our rigorous standards”, said FDA vaccine chief Dr Peter Marks.
“Having a vaccine authorised for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic,” Marks said.
Pfizer and its German partner BioNTech recently requested similar authorisation in the European Union, with other countries to follow.
The latest news is welcome for US families struggling to decide what activities are safe to resume when the youngest family members remain unvaccinated.
A  syringe with a dose of the Pfizer BioNTech COVID-19 vaccine in a vaccination centre in France [Stephane Mahe/Reuters]“I can’t feel totally comfortable because my boys aren’t vaccinated,” said Carrie Vittitoe, a substitute teacher and freelance writer in Louisville, Kentucky, who is fully vaccinated as are her husband and 17-year-old daughter.
The FDA decision means her 13-year-old son soon could be eligible, leaving only her 11-year-old son who would be unvaccinated.
Pfizer is not the only company seeking to lower the age limit for its vaccine.
Moderna Inc recently said preliminary results from a study in 12- to 17-year-olds show strong protection and no serious side effects. Another US company, Novavax, has a COVID-19 vaccine in late-stage development and just began a study in 12- to 17-year-olds, as well.
Next up is testing whether the vaccine works for even younger children. Both Pfizer and Moderna have begun US studies in children ages six months to 11 years.
Those studies explore whether babies, pre-schoolers and primary school-aged children will need different doses than teens and adults. Pfizer expects its first results sometime after September.
Outside of the US, AstraZeneca is studying its vaccine among 6- to 17-year-olds in the United Kingdom. And in China, Sinovac recently announced it has submitted preliminary data to Chinese regulators showing its vaccine is safe in children as young as three years old.







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Young Australians with disabilities lose out as Pfizer vaccine is rolled out to under-50s | Health From “World news | The Guardian”



Prioritising the Pfizer vaccine for residents under 50 has wrought havoc on Australia’s attempt to vaccinate young people with disabilities living in care homes against Covid.The federal health department has acknowledged it is yet to finalise a new plan to vaccinate the priority group.Medical professionals are now warning the cold chain delivery and specialist mobile teams required to administer the Pfizer vaccine in disability care homes are already at capacity because of the rollout across aged-care homes. A sick day by even a single staff member is forcing vaccinations scheduled for some facilities to be abandoned and their residents moved to the bottom of the queue.Meanwhile, experts have spoken of “consternation” at a lack of consultation by federal health authorities on vaccinations for Australians with disabilities living outside of care homes. In some cases, patients have been forced to leave their beds at hospitals, which have the capacity to administer vaccines, to travel to vaccine appointments elsewhere because of eligibility rules.As of Saturday, about 262,000 vaccine doses had been administered across the aged care and disability care sectors. The government does not routinely provide a specific breakdown of this figure, but federal health department officials told a Senate committee hearing on 20 April that fewer than 7% of disability care residents had received a single dose of vaccine.Both aged care and disability care residents fall under phase 1a of the rollout, but just 1,448 disability care residents had received their first dose by late April, with 25,000 yet to receive any dose.At the time, health teams administering vaccines were yet to visit about 6,000 disability care facilities across the country.The health department officials also told the committee that aged care residents were being prioritised within the cohort following the early April decision to prioritise AstraZeneca for over 50-year-olds and Pfizer for everyone younger, a move triggered by blood clot concerns for younger recipients of the AstraZeneca vaccine.However, the Guardian understands that private sector medical experts contracted by the government to vaccinate residents living in aged care facilities are already overworked, and are sceptical the rollout to disability care settings will be able to be hastened.Vaccinations at residential facilities are carried out by the private sector, with health teams scheduled to arrive at specific facilities on specific days. There, they meet private couriers contracted by the federal government, who are delivering the doses. DHL delivers the Pfizer vaccine, as its vehicles are capable of the refrigeration requirements, while Linfox delivers the AstraZeneca vaccine.People involved in the private sector rollout have told the Guardian the government “has not yet communicated well” its plans for the recalibrated disability rollout.“Frankly, even they don’t have an answer for a lot of this,” one of the people said.“Already we are overworked. When normal stuff goes wrong, there’s very little give in the system. If someone takes a few days off sick, then whichever aged care facility we had scheduled has to move back to the bottom of the queue, because there is no sensitivity to how overworked these people are.”Meanwhile, Prof Steven Faux, the director of rehabilitation at St Vincent’s hospital in Sydney, has warned that vaccinating Australians with disabilities, whether in hospitals or in care settings, requires a level of consideration he has yet to see from the federal health department.He said behavioural and physical issues meant recipients with disabilities could require significantly longer post-vaccine care than the 15 minutes of observation standard for other cohorts.“If you can’t walk and you need your arms to propel a wheelchair or move from bed to chair, then having a painful or weakened arm for 48 hours might lead you to be bedridden,” Faux wrote in the Guardian, urging the federal government to use state hospitals already equipped with disability care.When the Guardian asked the federal health department whether an updated plan to vaccinate Australians with disabilities under 50 living in group care homes had been devised, a spokeswoman confirmed that the rollout for this cohort was still being negotiated with states, territories and private sector providers.“During the recalibration phase the government worked closely with states and territories and weekly meetings were established to undertake this work as quickly as possible,” she said. “This included consideration of how to facilitate access to vaccines for those in priority cohorts including disability.”The spokeswoman said authorities aimed “to schedule vaccinations as soon as possible for people with disability living in residential accommodation of two or more people eligible under phase 1a”.Most states would resume vaccinating this cohort “over the coming weeks”, she said, but vaccinations in disability care homes had resumed only in the Australian Capital Territory and the Northern Territory last week.“The vaccination of people with disability in residential settings is a complex logistical operation which has commenced,” she said.







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Pfizer and BioNTech up Covid vaccine production capacity to 3 billion doses in 2021 — RT World News From “RT World News”



The CEO of BioNTech has said that the company and its partner Pfizer have been able to further increase production capacity of its highly sought-after Covid-19 vaccine, upping supply to around three billion doses in 2021.

Speaking at a webcast event organized by the Financial Times on Tuesday, BioNTech’s CEO and co-founder Ugur Sahin said that the company had been fortunate so far and was “not facing too many technical problems and keeping our delivery schedules.” Sahin said that production manufacturing capacity had now been ramped up to allow for the manufacturing of three billion BioNTech-Pfizer shots in 2021, up from a previous target of 2.5 billion.Our teams did a great job to further increase the manufacturing scale to come up now with numbers reaching three billion doses.In March, the Mainz-based biotech company said that its partners at Pfizer had increased their production capacity, allowing for 2.5 billion to be manufactured this year, of which 1.4 billion had already been sold. 

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Moderna targets production of 3bn Covid vaccines in 2022, after CEO warns of future oversupply

Last week, Moderna President Stephen Hoge said that his company would produce as many as three billion shots of their own jab in 2022, depending on how many shots are lower-dose formulations for boosters and immunization for children.The comments came after Moderna CEO Stephane Bancel warned that the world may have an oversupply of Covid-19 vaccines in 2022 and this could be challenging for developers such as themselves.China claims it will have the capacity to produce five billion jabs by the end of the year, while, Britain, a relatively small country by population, will be manufacturing at least three vaccines, AstraZeneca, Novavax and Valneva, before the end of 2021. Neither country is likely to manufacture the Pfizer or Moderna jab. If you like this story, share it with a friend!







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Covid-19: EU agrees potential 1.8 billion-dose purchase of Pfizer jab From “World News Headlines, Latest International News, World Breaking News – Times of India”



BRUSSELS: The European Union cemented its support for Pfizer-BioNTech and its novel Covid-19 vaccine technology Saturday by agreeing to a massive contract extension for a potential 1.8 billion doses through 2023. EU Commission President Ursula von der Leyen tweeted that her office “has just approved a contract for a guaranteed 900 million doses” with the same amount of doses as a future option. The new contract, which has the unanimous backing of the EU member states, will entail not only the production of the vaccines, but also making sure that all the essential components should be sourced from the EU. The European Commission currently has a portfolio of 2.6 billion doses from half a dozen companies. “Other contracts and other vaccine technologies will follow,” von der Leyen said in a Twitter message. Pfizer-BioNTech had an initial contract of 600 million doses with the EU. Saturday’s announcement also underscores the confidence the EU has shown in the technology used for the Pfizer-BioNTech vaccine, which is different from that behind the Oxford-AstraZeneca vaccine. The active ingredient in the Pfizer-BioNTech shot is messenger RNA, or mRNA, which contains the instructions for human cells to construct a harmless piece of the coronavirus called the spike protein. The human immune system recognizes the spike protein as foreign, allowing it to mount a response against the virus upon infection. The announcement of the huge contract extension comes as the European Union is looking for ways to meet the challenges of necessary booster shots, possible new variants and a drive to vaccinate children and teenagers. America’s Pfizer and Germany’s BioNTech have already said that they would provide the EU with an extra 50 million doses in the 2nd quarter of this year, making up for faltering deliveries of AstraZeneca. In contrast to the oft-criticized Anglo-Swedish AstraZeneca, von der Leyen has said that Pfizer-BioNTech is a reliable partner that delivers on its commitments. Two weeks ago, the EU launched legal proceedings against AstraZeneca for failing to respect the terms of its contract with the 27-nation bloc. The AstraZeneca vaccine had been central to Europe’s immunization campaign, and a linchpin in the global strategy to get vaccines to poorer countries. But the slow pace of deliveries has frustrated the Europeans and they have held the company responsible for partly delaying their vaccine rollout. So far, von der Leyen said, the EU has made some 200 million doses available to its 450 million citizens while almost as many have been exported from the bloc.







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Pfizer, BioNTech Seeks Full US Approval For COVID-19 Vaccine From “NDTV News – World-news”



The companies are now seeking a “Biologics License Application” for permanent regulatory approval (File)New York: Pfizer and BioNTech said Friday they were launching an application requesting full US regulatory approval for their game-changing Covid-19 vaccine for individuals 16 years and older.The two pharma companies plan to submit data in support of the application “on a rolling basis over the coming weeks” to the Food and Drug Administration (FDA), they said in a press release.The FDA approved the vaccine in December for emergency use, a designation permitted during public health emergencies. Since then, more than 170 million doses of the vaccine have been delivered in the United States.The companies are now seeking a “Biologics License Application” for permanent regulatory approval, which “requires longer-term follow-up data for acceptance and approval,” the companies said.The information will include data on the vaccine efficacy and safety profile up to six months after the second dose in a phase-three clinical trial.”We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the US government,” said Pfizer Chief Executive Albert Bourla.”We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”Pfizer and BioNTech have also submitted data to garner emergency use approval for individuals 12 to 15 years old. Pfizer said earlier in the week that it expects imminent US approval for this application.(This story has not been edited by NDTV staff and is auto-generated from a syndicated feed.)







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