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F.D.A. Grants Full Approval to Pfizer-BioNTech Covid Vaccine

F.D.A. Grants Full Approval to Pfizer-BioNTech Covid Vaccine

The Food and Drug Administration on Monday gave Pfizer-BioNTech’s coronavirus vaccine full approval for people aged 16 and over, making it the first to go beyond emergency status in the United States.

The decision will trigger a cascade of vaccine requests from hospitals, colleges, corporations, and other organizations. Secretary of Defense Lloyd J. Austin III will send vaccination guidelines to the country’s 1.4 million active military personnel, the Pentagon said on Monday.

United Airlines recently announced that its employees must provide proof of vaccination within five weeks of regulatory approval.

Oregon has introduced a similar requirement for all government employees, as have a variety of universities in the states of Louisiana through Minnesota.

Approval comes as the nation’s fight against the pandemic has re-intensified, with the highly contagious Delta variant dramatically slowing the country’s progress in the first half of the year. The Biden administration hopes the development will motivate at least some of the roughly 85 million unvaccinated Americans eligible for syringes.

President Biden plans to commemorate this in a speech urging vaccination, which is scheduled for 1:30 p.m. Eastern time on Monday afternoon. “If you haven’t been vaccinated, now is the time,” the president said on Twitter.

“While millions of people have safely received Covid-19 vaccines, we recognize that FDA approval of a vaccine may now create additional confidence for some to get vaccinated,” said Dr. Janet Woodcock, acting FDA commissioner, in a statement. “Today’s milestone brings us one step closer to changing the course of this pandemic in the US”

Pfizer said it provided the FDA with data from 44,000 participants in clinical trials in the United States, the European Union, Turkey, South Africa and South America. The company said the data showed the vaccine 91 percent prevented infection – a slight decrease from the 95 percent effectiveness rate the data showed when the FDA decided to approve the emergency vaccine in December. Pfizer said the decrease reflects the fact that researchers had more time to capture infected individuals.

A recent survey by the Kaiser Family Foundation, which tracked public attitudes during the pandemic, found that three in ten unvaccinated people said they were more likely to be vaccinated with a fully approved vaccination.

But pollsters and other experts warned that the percentage could be exaggerated. “I think that’s a tiny number of people in real life,” said Alison Buttenheim, an associate professor of nursing at the University of Pennsylvania and an expert on vaccination hesitation.

More important, says Dr. Buttenheim, is the effect of requirements. “Mandates make things easier for people,” she said.

Government action gives doctors more leeway to prescribe patients a third shot of the Pfizer vaccine, but federal officials strongly advised people not to seek additional vaccinations until regulators decide they are safe and effective. Pending regulatory approval, the federal government plans to offer booster syringes for adults next month.

The vaccine continues to be approved for emergency use in children ages 12-15 as Pfizer collects the data necessary for full approval. A decision on whether to approve the vaccine for children under the age of 12 could be at least several months away, and Dr. Woodcock said no child this age should get a Covid-19 vaccine due to a lack of safety data from regulators.

To date, more than 92 million Americans – 54 percent of those fully vaccinated – have received Pfizer vaccinations. Most of the others got the vaccine from Moderna.

Dr. Peter Marks, the FDA’s lead vaccine regulator, said the approval of Pfizer vaccine followed a rigorous review of hundreds of thousands of pages of data and included inspections of the factories where the vaccine is made. “The public and the medical community can rest assured that while we were swiftly approved this vaccine, it met our existing high standards for vaccines in the United States,” he said.

He said federal health officials would continue to monitor the safety of the vaccine and that the FDA would require Pfizer to assess the risks of myocarditis, an inflammation of the heart muscle, and pericarditis, an inflammation of the membrane surrounding the heart, including long-term results for the recipients. The FDA added warnings to the Pfizer-BioNTech and Moderna vaccines in June indicating a possible increased risk for these conditions after the second dose.

Although Pfizer can now market the drug under the Comiraty name, the company said only the federal government will be distributing doses in the United States.

Understand US vaccination and mask requirements

    • Vaccination rules. On August 23, the Food and Drug Administration fully approved Pfizer-BioNTech’s coronavirus vaccine for people aged 16 and over, paving the way for increased mandates in both the public and private sectors. Private companies are increasingly demanding vaccines for employees. Such mandates are legally permissible and have been confirmed in legal challenges.
    • Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of vaccination status, wear masks in public places indoors in areas with outbreaks, reversing the guidelines offered in May. See where the CDC guidelines would apply and where states have implemented their own mask guidelines. The battle over masks is controversial in some states, with some local leaders defying state bans.
    • College and Universities. More than 400 colleges and universities require a vaccination against Covid-19. Almost all of them are in states that voted for President Biden.
    • schools. Both California and New York City have introduced vaccination mandates for educational staff. A survey published in August found that many American parents of school-age children are opposed to mandatory vaccines for students but are more likely to support masking requirements for students, teachers and staff who are not vaccinated.
    • Hospitals and medical centers. Many hospitals and large health systems require their employees to have a Covid-19 vaccine, due to increasing case numbers due to the Delta variant and persistently low vaccination rates in their communities, even within their workforce.
    • New York City. Proof of vaccination is required by workers and customers for indoor dining, gyms, performances, and other indoor situations, though enforcement doesn’t begin until September 13. Teachers and other educational workers in the city’s vast school system are required to have at least one vaccine dose by September 27, with no weekly testing option. City hospital staff must also be vaccinated or have weekly tests. Similar rules apply to employees in New York State.
    • At the federal level. The Pentagon announced that it would make coronavirus vaccinations compulsory for the country’s 1.3 million active soldiers “by mid-September at the latest. President Biden announced that all civil federal employees would need to be vaccinated against the coronavirus or undergo regular tests, social distancing, mask requirements and travel restrictions.

Health experts and state officials welcomed the development. With the delta variant driving up case numbers across the country, “full approval could not come at a more important time,” said Dr. Richard Besser, President of the Robert Wood Johnson Foundation and former acting director of the Centers for Disease Control and Prevention. He urged schools and businesses to require a vaccination before people can gather indoors.

Less than two months after the spread of the virus appeared to be contained, the US is now recording an average of around 150,000 new cases per day and more than 90,000 hospitalized Covid-19 patients. An average of around 1,000 per day die from Covid-19 – a toll that federal health experts recently dismissed as highly unlikely before the delta variant fully caught on. Many children under the age of 12 also become infected.

Vaccination rates have also risen in the past few weeks, in part because of the greater fear of the virus. Vendors were delivering approximately 837,000 shots a day, a significant increase from earlier this summer.

Some experts estimated that full consent could only convince five percent of the unvaccinated to get injected. Even if that is the case, “that is still a huge part of the people,” Dr. Thomas Dobbs, the Chief Health Officer of Mississippi, a state particularly hard hit by the Delta variant. He said the approval will help “get rid of this false claim that the vaccines are an ‘experimental’ thing”.

Dr. Marks, the vaccines agency, cited a number of other myths about the vaccines as a major stumbling block in fighting the pandemic, including false claims that the vaccinations cause infertility, promote Covid disease rather than prevent it, or have resulted in thousands of deaths. “Let me be clear. These claims are just not true,” he said.

The FDA is in the middle of a decision marathon related to coronavirus vaccines. The next important question emerging for regulators is whether or not to approve booster injections. The Biden government said last week it plans to offer third vaccinations starting September 20, for adults who received the Pfizer and Moderna vaccines eight months after their second injection. Third vaccinations are already approved for some people with immunodeficiency, but the risk-benefit ratio is different for the general population.

Federal health officials said that both Pfizer-BioNTech and Moderna’s vaccines, which are based on similar technology, lose effectiveness over time. That trend is converging with the advent of the particularly dangerous Delta variant, making those who completed their vaccinations earlier in the year increasingly more susceptible to infection.

Some health experts have challenged the decision to recommend booster vaccinations as premature, as the data showed the vaccines withstand serious illness and hospitalization, including the Delta variant. Boosters would only be justified if the vaccines didn’t prevent hospital stays with Covid-19, some of these experts said.

Regulators are still examining Moderna’s application for full approval of its vaccine. This decision can take several weeks. Johnson & Johnson is expected to file for full approval shortly.

Helene Cooper contributed to the reporting.

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FDA Authorizes Pfizer-BioNTech Vaccine for Kids 12 to 15

FDA Authorizes Pfizer-BioNTech Vaccine for Children 12 to 15

Vaccinating children is vital to boost population immunity and contain the spread of the coronavirus. Although children spread the virus less efficiently than adults, they make up about 23 percent of the population.

Experts have said the country is unlikely to reach “herd immunity” – the point where virus transmission essentially comes to a halt – but vaccinating children will be important to get as close as possible .

14-year-old Ty Dropic, one of the study participants, urged others his age to get vaccinated so they can build widespread immunity and protect themselves. He had no side effects, which led him to suspect that he was on the placebo. If this turns out to be the case, he plans to be vaccinated as soon as possible.

“I know it can be scary, but it really isn’t as bad as it seems,” he said. “If you get Covid it will be a lot worse than being stuck with a needle for two seconds.”

Ty’s three siblings, ages 8, 10, and 16, are also participating in vaccination trials for their age groups. Your mother, Dr. Amanda Dropic, a pediatrician in northern Kentucky, said most of the parents in her practice were eager to get their children vaccinated to help them regain some semblance of normalcy.

“The anxiety and depression that we see in children, the social delays, have been enormous,” she said.

Dr. Dropic said her children understood the risks and were willing to volunteer because they saw it as a civic duty. Every drug available today came about because “someone was ready to go first,” she added.

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Scientist who helped develop Pfizer-BioNTech Covid vaccine agrees third shot is required as immunity wanes

Scientist who helped develop Pfizer-BioNTech Covid vaccine agrees third shot is needed as immunity wanes

BioNTech’s chief medical officer told CNBC on Wednesday that people will likely need a third shot of its two-dose Covid-19 vaccine to lower immunity to the virus. This is in line with previous comments from Pfizer CEO Albert Bourla.

Dr. Ozlem Tureci, co-founder and CMO of BioNTech, who developed a Covid vaccine together with Pfizer, also assumes that people need to be vaccinated against the coronavirus every year, for example against seasonal flu. That’s because scientists expect vaccine-induced immunity to the virus to decline over time.

“We see evidence of this in the induced, but also natural, immune response against SARS-COV-2,” she said during an interview with Kelly Evans of CNBC in “The Exchange”. “We see this decrease in immune responses also in people who have just been infected and therefore [it’s] also expected with the vaccines. “

Tureci’s comments come after Pfizer CEO Albert Bourla said in an interview broadcast on April 15 that people will likely need a booster shot or third dose of the Covid-19 vaccine within 12 months of being fully vaccinated. He also said that there is a possibility that people will have to take extra shots every year.

Pfizer said earlier this month that its Covid-19 vaccine was more than 91% effective against the virus and more than 95% effective against serious illness up to six months after the second dose. Moderna’s vaccine, which uses technology similar to Pfizer, has also been shown to remain highly effective after six months.

The researchers say they still don’t know how long protection against the virus will last after six months of full vaccination, although public health officials and health experts believe that protection will wear off after some time.

Should Americans need booster vaccinations, the US government would likely need to reach agreements with drug manufacturers to provide additional doses and make plans to distribute vaccines.

On Friday Andy Slavitt, senior advisor to President Joe Biden’s Covid Response Team, said the Biden administration was preparing for the potential need for Covid-19 vaccine booster shots. He said the government was considering the need to secure additional doses.

“I can assure you that as we plan, if the President orders the purchase of additional vaccines, as he has, and if we focus on all of the production expansion opportunities that we are talking about, we have a great many such scenarios in mind have. “he said.

Last week, David Kessler, chief science officer for the Biden government at Covid, said Americans should expect to receive booster vaccinations to protect against coronavirus variants. He told US lawmakers that currently approved vaccines offer high levels of protection, but that new variants may “question” the effectiveness of the shots.

“We don’t know everything right now,” he told the House Select subcommittee on the coronavirus crisis.

“We are investigating the durability of the antibody response,” he said. “It seems strong, but that’s wearing off a bit, and no doubt the variants are challenging … they make these vaccines work harder. So I think for planning purposes, planning purposes only, we should expect us to may have to. ” Boost. “

Stephane Bancel, CEO of Moderna, told CNBC last week that the company hopes to have a booster shot for its two-dose vaccine in the fall.

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The Pfizer-BioNTech Vaccine Is Stated to Be Powerfully Protecting in Adolescents

The Pfizer-BioNTech Vaccine Is Said to Be Powerfully Protective in Adolescents

The Pfizer BioNTech coronavirus vaccine is extremely effective in adolescents ages 12 to 15, perhaps even more effective than it is in adults, the companies reported on Wednesday. No symptomatic infections were found in children who received the vaccine in a recent clinical study. The children showed strong antibody reactions and did not show any serious side effects.

The results, if persistent, could accelerate the return to normal for millions of American families. Depending on government approval, vaccinations for middle school, high school and elementary school children might start not long before the start of the next school year.

The companies announced the results in a press release that did not include detailed data from the study that had not yet been peer-reviewed or published in a scientific journal. Still, the news was praised and excited by experts.

“Oh my god, I’m so happy to see this – it’s amazing,” said Akiko Iwasaki, an immunologist at Yale University. If the vaccine performance was A-plus in adults, the results in children were A-plus-plus.

The good news comes even if the country sees a renewed surge in infections and health officials again urge Americans to follow precautions and get vaccinated. On Monday, Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said rising cases left her feeling of “impending doom” while President Biden urged state and local officials to reinstate mask mandates.

Vaccination efforts are accelerating across the country. By Tuesday, 29 percent of Americans had received at least one dose of a coronavirus vaccine, and 16 percent had been fully vaccinated, according to the CDC

But the country cannot hope to achieve herd immunity – the point where immunity becomes so widespread that the coronavirus is slowing its passage through the population – without vaccinating the youngest Americans as well, some experts say. Children under the age of 18 make up approximately 23 percent of the population in the United States.

“The sooner we can get vaccines against as many people as possible, regardless of their age, the sooner we will feel like we are ending this pandemic for good,” said Angela Rasmussen, a virologist at Georgetown University in Washington.

Data from Israel suggest that vaccination in adults alone can significantly reduce the number of cases. “However, in order to reach the herd immunity threshold in the long term, we need to vaccinate children,” she said.

The study included 2,260 adolescents aged 12 to 15 years. The children received two doses of the vaccine three weeks apart – the same amounts and the same schedule as for adults – or a placebo with salt water.

The researchers registered 18 cases of symptomatic coronavirus infection in the placebo group and none among the children who received the vaccine. However, the low number of infections makes it difficult to accurately determine the effectiveness of the vaccine in the general population, said Dr. Rasmussen.

“But obviously it looks good for the vaccine if there are no Covid cases among the vaccinated people,” she added.

The adolescents who received the vaccine produced, on average, many more antibodies than those aged 16-25 in a previous study. The children experienced the same minor side effects as older participants, although the companies refused to be more specific.

Updated

March 31, 2021, 9:45 a.m. ET

Dr. Iwasaki said she expected antibody levels in teenagers to be comparable to those in young adults. “But they get even better readings from the vaccines,” she said. “That is really unbelievable.”

She and other experts warned that the vaccine may be less effective in children and adults against some of the variants that have come into circulation in the United States.

Pfizer and BioNTech started a clinical trial of the vaccine in children under the age of 12 just last week, and started vaccinating children ages 5 to 11. Scientists at the company plan to test the vaccine in even younger children ages 2 to 5 next week, followed by trials in children ages 6 months to 2 years.

Results from this three-phase study are expected in the second half of the year, and the companies hope to make the vaccine available to children under the age of 12 early next year.

“We share the urgency to expand the use of our vaccine to wider populations and are encouraged by data from clinical trials in adolescents 12-15 years of age,” said Albert Bourla, Pfizer chairman and CEO, in a statement.

Moderna has also tested its vaccine in children. Results of a study in adolescents aged 12 to 17 years are expected in the next few weeks and in children aged 6 months to 12 years in the second half of this year.

AstraZeneca started testing its vaccine in children 6 months and older last month, and Johnson & Johnson has announced that it will wait for the results of studies in older children before testing the vaccine in children under the age of 12.

Some parents have stated that they are reluctant to immunize their children because the risk of the virus is low. Children account for less than 1 percent of deaths from Covid-19, but about 2 percent of children with the disease require hospital care.

The new results may not affect all of these parents, but they can reassure parents who have been wary of vaccines, said Jennifer Nuzzo, an epidemiologist at the Johns Hopkins Center for Health Security.

“While I don’t think we have to wait for the children to be vaccinated to fully reopen schools, the ability to vaccinate children can help some families feel more secure when they return to school,” said they.

Pfizer and BioNTech plan to apply to the Food and Drug Administration for an emergency approval change for their vaccine in hopes of starting vaccinating older children before the start of the next school year. The companies also plan to submit their data for review and publication in a scientific journal.

You will monitor participants for two years after the second dose to assess the long-term safety and effectiveness of the vaccine. Vaccine side effects usually appear within the first six weeks, said Dr. Kristin Oliver, pediatrician and vaccine expert at Mount Sinai Hospital in New York. “Even so, it is good to know that security surveillance is continuing,” she said.

The CDC recommends that people do not receive any other vaccines for two weeks before and after receiving the two doses of the coronavirus vaccine.

But kids are getting more vaccines than ever before in the few weeks leading up to the school year, according to Dr. Oliver. Therefore, pediatricians and parents should try to get these other vaccinations earlier than usual.

The coronavirus vaccines should ideally be given by pediatricians with extensive experience immunizing children, added Dr. Oliver added. “Now is the time to plan how this rollout will take place in this age group,” she said.

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Hong Kong Suspends Pfizer-BioNTech Vaccine Use Over Packaging Defects

Hong Kong Suspends Pfizer-BioNTech Vaccine Use Over Packaging Defects

Hong Kong on Wednesday suspended use of the Pfizer BioNTech vaccine after packaging defects ranging from cracked containers to loose caps were discovered in a batch of cans. This was a major blow to a city that was already struggling to vaccinate its seven million residents against Covid-19.

Health officials called the stop a precaution, saying that none of the broken vials had been administered to patients and that they had not identified any health risks. However, if the suspension continues, Chinese territory may not have had enough shots to protect its population as the coronavirus continues to spread. Hong Kong officials counted 7.5 million doses of the vaccine, which was developed by Pfizer in the US and BioNTech in Germany to meet their needs.

The discovery has also sparked a hunt for the source of the flaws, as well as questions whether there might be more out there. The cans were made in BioNTech’s factories in Germany, while a Chinese company called Fosun Pharma was responsible for the transport, storage and distribution of the recordings in Hong Kong.

“I’m confused about why this is being reported for the first time in Hong Kong and we haven’t heard about it anywhere else,” said Benjamin Cowling, head of epidemiology and biostatistics at the University of Hong Kong.

“Was there anything special about that particular batch? Presumably they were made in the same way as the other batches in Germany. “

In a statement on Wednesday, BioNTech said the batch in question had only been sent to Hong Kong and Macau, another nearby Chinese area. The company said it is investigating the root cause of the problem.

“At this point in time, we have no reason to believe that there is a safety risk to the population,” said BioNTech.

Fosun Pharma said BioNTech had identified problems with the lids within a batch of vaccines shipped to Hong Kong and Macau, where authorities have also suspended vaccine administration. Fosun Pharma shares fell 4.8 percent in Hong Kong trading on Wednesday.

Hong Kong’s vaccination campaign has already been plagued by public doubts. Vaccine bookings were down after reports were made that several people died after receiving the other vaccine Hong Kong uses, made by Sinovac, a Beijing-based company. Residents tried hard to book appointments for the BioNTech vaccine, which, according to official figures, had booked about twice as many as Sinovac in the past six days.

The Hong Kong government has not found a direct link between the shooting and the deaths. However, some people do not trust the government after mainland China officials tightened their control over the former British colony following anti-government protests in 2019.

In January, a poll of 2,733 residents found that only 39 percent of Hong Kong residents were willing to take a Covid-19 vaccine.

“There are some key risks here that further undermine confidence in the vaccines available,” said Karen Grépin, associate professor at the University of Hong Kong’s School of Public Health, who received the BioNTech shot on March 12.

Professor Grépin said many Hong Kong residents waited to see what the early stages of the rollout would be before deciding on a vaccine.

The suspension created uncertainty in the city’s clinics and doctor’s offices as vaccinations stalled.

Lindsay Eng, 36, was vaccinated at 9:11 a.m. on Wednesday. When she was sitting in the waiting area afterwards, she noticed that no more people were coming in. When she left the center, the staff put up a sign saying that the vaccination service had stopped. A lot of people who came to have their vaccinations were asked questions.

Ms. Eng said she was not particularly concerned for her own health but was more concerned that the incident would result in fewer people being vaccinated in Hong Kong.

“Just talking to the locals here is pretty clear that there are a lot of people who say, ‘Let’s wait and see,'” said Ms. Eng, who is from Toronto but has elderly family members in Hong Kong who hesitate Received vaccine.

Hong Kong officials had reached out to Fosun for answers after receiving reports from frontline workers and pharmacists about defective vials and packaging, Hong Kong health director Constance Chan said in a news conference on Wednesday. The defects were found before the doses were administered, she said, adding that workers carefully inspected containers and vials.

In total, the government received eight reports of cracked containers, 22 reports of leaks, 16 reports of loose closures, and 11 reports of stains or marks on the outside of bottles, said Dr. Chan.

The defective cans were part of a batch of 585,000 cans with the order number 210102, the Hong Kong government said on Wednesday, citing data from a subsidiary of Fosun in Hong Kong. So far, 150,200 people had received shots from this batch, according to the government.

Authorities said they would hold another batch of 758,000 doses of the BioNTech vaccine with catalog number 210104.

“This is a precautionary measure to ensure the safety of the vaccine continuously,” the Hong Kong government said in a statement.

According to Dr. Chan would work with Fosun to work with BioNTech to conduct factory site inspections in Germany.

Compared to the USA and Great Britain, Hong Kong has started its vaccination campaign only slowly. Just over 5 percent of Hong Kong’s 7.5 million residents have been vaccinated. The city has reported more than 11,000 cases and 204 deaths since the pandemic began, but it has just beaten back a new outbreak that resulted in hundreds of people being rounded up for quarantine.

It is unclear when concerns about the Pfizer BioNTech vaccine will be addressed or how quickly Hong Kong can make up the deficit. The city has also ordered 7.5 million doses of vaccine from Anglo-Swedish company AstraZeneca, which are expected to arrive in the second quarter. The company has not yet filed for approval of its vaccine in Hong Kong.

As quickly as the problem was resolved, confusion was created.

Ruby Callaghan Brown, 32, and her husband arrived at a vaccination center on the east side of Hong Kong Island at 7:45 a.m. on Wednesday. 15 minutes before opening. A staff member shooed her away, saying that all vaccinations had been stopped and that an announcement would come.

Then they read online that the center had reopened and returned. they were about to submit their records when they were told again that the vaccinations had been suspended.

They waited 45 minutes before leaving. “I thought I was just going to sit here until you change your mind,” she said.

Elsie Chen contributed to the research.

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Pfizer-BioNTech vaccine prone to be efficient in opposition to UK variant

Pfizer to temporarily reduce Covid vaccine deliveries to Europe

A picture taken on January 15, 2021 shows a pharmacist holding a vial of undiluted Pfizer BioNTech vaccine for Covid-19 with gloved hands, which is stored at -70 ° in a super freezer at Le Mans hospital in northwestern France became country runs a vaccination campaign to fight the spread of the novel coronavirus.

Jean-Francois Monier | AFP | Getty Images

LONDON – The coronavirus vaccine developed by Pfizer-BioNTech is likely just as effective against a highly transmissible mutant strain of the virus, first discovered in the UK, according to a study by the two companies.

It was estimated that those listed as B.1.1.7. Well-known variant first appeared in the UK in September 2020. It has an unusually high number of mutations and is associated with more efficient and faster transmission.

The characteristics of the variant had raised concerns about the effectiveness of Covid vaccines against them.

However, studies published on the preprint server bioRxiv showed “no biologically significant difference in the neutralization activity” between the laboratory tests on B.1.1.7 and the original strain of the coronavirus.

The study, which has not yet been peer-reviewed, found that all of the mutations associated with the newly discovered variant were neutralized by antibodies in the blood of 16 participants who had previously been given the vaccine.

Half of the participants were between 18 and 55 years old and the other half between 56 and 85 years old.

The study’s authors warned of the rapid spread of Covid variants around the world, which required “continuous monitoring of the importance of changes in maintaining protection from currently approved vaccines.”

It is the first of its kind to be completed by a major Covid vaccine manufacturer as other pharmaceutical companies scramble to test the effectiveness of their respective vaccines.

Moderna and AstraZeneca, who worked with Oxford University to develop a Covid vaccine, both previously announced that their vaccines will be effective against B.1.1.7.

Virus spread

Earlier this month, Dr. Ugur Sahin, co-founder and CEO of BioNTech, told CNBC that the German pharmaceutical company is confident that its vaccine will develop an immune response against B.1.1.7.

Sahin said he believes the vaccine should also prove effective against a variant discovered in South Africa – another highly transmissible variant that has caused concern among public health experts.

His comments came shortly after initial tests showed 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. Now, scientists from both companies have published research indicating that the vaccine is likely to be effective against all mutations associated with B.1.1.7.

In recent weeks, optimism about the global roll out of Covid vaccines has been tempered by the resurgent rate of spread of the virus.

To date, more than 96.2 million people have contracted the coronavirus, according to Johns Hopkins University, with 2.05 million people dying.

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EU broadcasts 300 million extra doses of Pfizer-BioNTech covid vaccine

EU announces 300 million more doses of Pfizer-BioNTech covid vaccine

European Commission President Ursula von der Leyen holds a press conference in Brussels, Belgium on December 13, 2020 after speaking to British Prime Minister Boris Johnson on the phone.

Olivier Hoslet | Reuters

LONDON – The European Union doubles its inventory of Pfizer BioNTech coronavirus vaccines as concerns about adoption mount across 27 member states.

The vaccine developed with German biotechnology was the first to be approved by European regulatory authorities. It has been administered across the region since December 27th. However, the rollout was inconsistent and the European Commission was criticized for not buying more vaccine.

The Commission has argued that, at the request of Member States, it has a diversified portfolio of vaccination contracts, totaling up to 2.3 billion doses of “the most promising candidates”.

“As you know, we currently have access to 300 million doses of the BioNTech-Pfizer vaccine. Now the good news is: we have now agreed with BioNTech-Pfizer to renew this contract. With the new agreement, we could buy more in total another 300 million cans, “said the President of the Commission, Ursula von der Leyen, at a press conference on Friday.

This would mean the EU is on track to receive 600 million doses of this vaccine. Speaking to CNBC in December, Pfizer’s CEO pledged to produce a total of 1.3 billion cans in 2021, which would mean Europe would get almost half of its annual output.

75 million cans of the new order will be available in the second quarter of 2021. The rest will be delivered in the third and fourth quarters.

The Netherlands only started vaccinating its citizens this week and the bureaucracy has reportedly made France one of the biggest stragglers in distributing the shock.

According to the European Center for Disease Prevention and Control, more than 15 million cases of coronavirus have been reported in the region to date.

European regulators approved a second coronavirus vaccine on Wednesday. Moderna’s candidate is expected to be available to European citizens in the coming days.

“Europe will have more than enough vaccines within a reliable timeframe, and this shows that the path that we have taken in the European Union is the right one,” said von der Leyen on Friday, rejecting the criticism.

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The UK is delaying second Pfizer/BioNTech shot: Here is what we all know

The UK is delaying second Pfizer/BioNTech shot: Here's what we know

The medical staff will receive the Pfizer-Biontech Covid-19 coronavirus vaccine in the Favoriten Clinic in Vienna on December 27, 2020 on the occasion of the launch of the Pfizer-BioNTech Covid-19 coronavirus vaccine.

Georg Hochmuth | AFP | Getty Images

The UK’s decision to delay the administration of the second dose of a coronavirus vaccine is controversial as experts, advisors and vaccine manufacturers weigh the strategy.

The UK was one of the first countries in the world to launch a mass vaccination campaign against the coronavirus after approving the Covid-19 vaccine developed by Pfizer and BioNTech in early December. Oxford University and AstraZeneca began rolling out the vaccine on Monday of this week after it was approved for use just before the New Year.

As both vaccines require two doses per person, the UK government initially said that a second dose would be given either three or four weeks after the first dose, depending on which vaccine was given and in line with the dosage regimens tested in clinical trials.

However, a break of up to 12 weeks is now recommended to give more people an initial dose – and initial protection against Covid-19.

Concerns from the vaccine manufacturer

BioNTech and Pfizer have responded to the decision, saying there is no evidence that their vaccine will continue to protect against Covid-19 if the second shot is given more than 21 days after the starting dose.

“Pfizer and BioNTech’s Phase 3 study of the COVID-19 vaccine was designed to evaluate the safety and efficacy of the vaccine on a 2-dose regimen separated by 21 days. The safety and efficacy The majority of study participants received the second dose within the window specified in the study design, “the companies said in a statement to CNBC on Tuesday.

“Although data from the Phase 3 study showed partial protection from the vaccine as early as 12 days after the first dose, there is no data to show that protection is maintained after 21 days after the first dose.”

The companies said it was now “critical to conduct surveillance efforts” with alternative dosing schedules in place.

The final analysis of data from the Pfizer / BioNTech clinical trials found the vaccine to be 95% effective given seven days after the second dose in preventing Covid-19.

For the Oxford University / AstraZeneca candidate, the interim analysis of the late-stage study results was somewhat more nuanced, as the vaccine doses to the study participants showed an anomaly. When the vaccine was given in two full doses, it was found to be 62.1% effective, but when some study participants received half a dose followed by a full dose of 90%. In both dosing regimens, the two shots were given one month apart. AstraZeneca was not immediately available for comment on the UK’s decision to postpone the second dose.

Reasons for the decision

The decision to extend the dosage window is made as UK hospitals struggle with increasing admissions. The coronavirus is running amok in the UK, with a new, transmissible strain of the virus spreading exponentially in London and the South East, and now appearing in other parts of the country.

To date, the country has recorded over 2.6 million cases of coronavirus and more than 75,000 deaths, according to Johns Hopkins University. The UK recorded 58,784 new cases on Monday and has now reported more than 50,000 new coronavirus cases for seven days in a row. On Monday, British Prime Minister Boris Johnson announced a third nationwide lockdown for England.

Against this dire backdrop, the UK Medicines Agency, Joint Vaccination and Immunization Committee and the UK’s four chief medical officers agreed to move the gap between the first and second vaccine dose to “protect the greatest number of people in India” the shortest Time. “

There are signs that other Britain may follow suit. The German Ministry of Health is now asking an independent vaccination commission for advice on whether the British strategy on dose delay should be adhered to. Denmark has reportedly already approved a delay of up to six weeks between the first and second vaccinations.

‘Finely balanced’

So far, more than a million people in the UK have been vaccinated with the Pfizer / BioNTech vaccine, according to government figures, and some, like the first recipient of this vaccine outside of a clinical trial, have received their second dose.

But now, thousands of others in the top priority category are being told to wait up to 12 weeks for their second dose.

The British Medical Association described the move as “grossly unfair” to thousands of high-risk patients in England, but the UK’s Independent Scientific Advisory Group on Emergencies (SAGE) said in a statement released on Sunday that it was a “very difficult and finely balanced” move be decision. “

In response to the BMA’s concerns, SAGE said, “Under normal circumstances, we would advocate continuing our previous plans to give two doses of the Pfizer BioNTech vaccine 21 days apart. However, these are not normal circumstances, and so it is are other important public health considerations. “

The UK is prioritizing vaccination of elderly care home residents, their carers, people over 80, and frontline health and social workers.

The country has pre-ordered 40 million doses of the Pfizer / BioNTech vaccine, enough for 20 million people, and signed a contract with AstraZeneca for 100 million doses, enough for 50 million people. There are around 66 million people in Great Britain.

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Health

Pfizer-BioNTech vaccine paperwork ‘unlawfully accessed’ in EMA hack

Pfizer-BioNTech vaccine documents ‘unlawfully accessed’ in EMA hack

A man will receive the first of two Pfizer / BioNTech Covid-19 stitches on December 8, 2020 at Guy’s Hospital in London.

Victoria Jones | AFP | Getty Images

LONDON – Documents related to the development of the Pfizer-BioNTech Covid-19 vaccine were “illegally accessed” in a cyberattack on the European Medicines Agency.

The EMA said in a brief statement on its website on Wednesday that it was “the subject of a cyberattack” and has opened an investigation “with law enforcement and other relevant authorities”.

The regulator did not disclose details of the nature of the attack, but BioNTech announced on its website that documents contained in the regulator’s filing and stored on an EMA server were accessed. It is unclear exactly which documents were accessed and by whom.

“It is important to note that no BioNTech or Pfizer systems were breached in connection with this incident, and we do not know that study participants were identified through access to the data,” BioNTech said.

The German biotech company said it had decided to release details of the hack “given the critical public health considerations and the importance of transparency”.

The EMA, which approves the use of medicines across the European Union, is currently reviewing two Covid-19 shocks. One is from Pfizer and BioNTech, the other from Moderna. It is not known whether Moderna documents were also accessed.

The regulator is expected to announce a decision in the coming weeks on whether the vaccines are safe across Europe.

“EMA has assured us that the cyberattack will not affect the schedule for its review,” said BioNTech.

Hackers target vaccine

Last week, IBM researchers announced that hackers had also attempted to attack the cold store supply chain that transports vaccines at low temperatures. The researchers warned that a nation-state would likely be behind the effort.

Security officials said in July that hackers linked to Russian intelligence services were attempting to steal information about coronavirus vaccine research in the US, Canada and the UK. Kremlin spokesman Dmitry Peskov denied the allegations, according to the state news agency TASS.

The UK’s National Cyber ​​Security Center said: “The NCSC supports the research and manufacture of essential vaccines to defend against cyber threats.”

“We are working with international partners to understand the impact of this incident on the EU Medicines Agency. However, there is currently no evidence that the UK Medicines Agency is affected.”