Tag: Vaccine

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Dr. Fauci says Covid vaccine trials on pregnant ladies and younger children might start in January

Dr. Fauci says Covid vaccine trials on pregnant women and young kids could begin in January

Drug makers and U.S. regulators plan to start clinical trials in January testing the safety of Covid-19 vaccines in pregnant women and young children, said Dr. Anthony Fauci, director of the National Institute for Allergies and Infectious Diseases.

These two groups were excluded from the initial clinical trials of Covid-19 vaccines until researchers were able to determine that the vaccine was relatively safe in healthy adults before testing in more susceptible populations.

Fauci noted on Thursday in a discussion sponsored by Columbia University on Thursday that pregnant women have not been included in clinical trials of Covid vaccines. It is not clear whether the omission means that pregnant women cannot receive an approved vaccine until further safety data are collected.

Studies on pregnant women will be done in later studies, he said.

“It won’t necessarily concern efficacy, but we will be investigating safety and immunogenicity to bridge efficacy in the adult non-pregnant population,” he said at Columbia University’s Grand Rounds 2020 event. “The same goes for the pediatric population. These studies are expected to begin in mid-to-late January.”

Doctors have noted an increased risk of complications in pregnant women who contract Covid-19, said Aron Hall, chief of Covid at the CDC.

“The first indication is that there may be a higher risk of premature delivery,” he said Thursday on the FDA’s Advisory Committee on Vaccines and Related Biological Products.

While young children are less likely to die of Covid-19 when they get it, there is an increased risk of developing what is known as multisystem inflammatory syndrome in children, or MIS-C, researchers have found. It is an inflammatory disease that can affect several organ systems throughout the body, including the heart, lungs, and brain.

Fauci’s comments came as the FDA’s Vaccine Advisory Board is weighing whether to recommend Pfizer’s emergency approval of the Covid vaccine.

Data on Pfizer’s vaccine has shown it to be remarkably effective in preventing disease among study participants, and the FDA is expected to approve emergency use as early as Friday.

The UK drug and health products regulator, which last week approved Pfizer’s vaccine for wide use in adults, warned against giving it to pregnant or breastfeeding women.

Dr. Doran Fink, associate director of the FDA’s vaccines and related products division, said Thursday there was “very limited data on use in pregnancy”.

“We recognize that among the groups first prioritized for vaccine use under an EEA, there will be many women of childbearing potential, including women who are knowingly or unknowingly pregnant,” he said on the Meet on Thursday afternoon. “We really do not have any data that suggest any specific risks to pregnant women or the fetus, but neither do we have any data that would justify a contraindication to use in pregnancy at this time.”

He added that pregnant women and women of childbearing age are “free to make their own choice” under what is known as an emergency permit.

The FDA advised manufacturers, including Pfizer, to conduct DART studies or developmental and reproductive toxicity studies before including pregnant women and “women of childbearing potential who do not actively avoid pregnancy” in vaccine studies, Pfizer said – Speaker Jerica Pitts CNBC. DART studies are done in animals to assess the potential risks of a vaccine to a developing fetus.

“Pfizer recognizes that the development of a potential SARS-CoV-2 vaccine for wide use is critical to halting the pandemic, including potential use in pregnant women,” Pitts said in a statement. “Pfizer is currently conducting DART studies and plans to provide available data to the agency.”

Pfizer admitted at the FDA’s vaccine meeting Thursday that according to a presentation there was no information about the effects of the vaccine on pregnant women. Company officials told the advisory board that they expected preliminary results from its DART studies by mid-December.

The company also noted that there is also a lack of information on the effects of the vaccine in children and adolescents under the age of 16. The FDA advisory panel will vote on its non-binding recommendation later Thursday, and the FDA is expected to do so soon.

– CNBC’s Amanda Macias contributed to this report.

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Health

F.D.A. Panel Provides Inexperienced Mild to Pfizer’s Covid Vaccine

F.D.A. Panel Gives Green Light to Pfizer's Covid Vaccine

Pfizer’s Covid-19 vaccine passed a critical milestone on Thursday when a panel of experts formally recommended that the Food and Drug Administration authorize the vaccine. The agency is likely to do so within days, giving health care workers and nursing home residents first priority to begin receiving the first shots early next week.

The F.D.A.’s vaccine advisory panel, composed of independent scientific experts, infectious disease doctors and statisticians, voted 17 to 4, with one member abstaining, in favor of emergency authorization for people 16 and older. With rare exceptions, the F.D.A. follows the advice of its advisory panels.

With this formal blessing, the nation may finally begin to slow the spread of the virus just as infections and deaths surge, reaching a record of more than 3,000 daily deaths on Wednesday. The F.D.A. is expected to grant an emergency use authorization on Saturday, according to people familiar with the agency’s planning, though they cautioned that last-minute legal or bureaucratic requirements could push the announcement to Sunday or later.

The initial shipment of 6.4 million doses will leave warehouses within 24 hours of being cleared by the F.D.A., according to federal officials. About half of those doses will be sent across the country, and the other half will be reserved for the initial recipients to receive their second dose about three weeks later.

The arrival of the first vaccines is the beginning of a complex, monthslong distribution plan coordinated by federal and local health authorities, as well as large hospitals and pharmacy chains, that if successful, will help return a grieving and economically depressed country back to some semblance of normal, maybe by summer.

“With the high efficacy and good safety profile shown for our vaccine, and the pandemic essentially out of control, vaccine introduction is an urgent need,” Kathrin Jansen, a senior vice president and the head of vaccine research and development at Pfizer, said at the meeting.

The vote caps a whirlwind year for Pfizer and its German partner BioNTech, which began working on the vaccine 11 months ago, shattering all speed records for vaccine development, which typically takes years. It is also a triumph for the F.D.A., which has upheld its reputation as the world’s gold standard for drug reviews despite months of political pressure from President Trump, who has sought to tie his political fortunes to the success of a vaccine. The Pfizer vaccine has already been given to people in Bahrain and Britain, where it was authorized on Dec. 2. Canada approved it on Wednesday.

The U.S. authorization of Pfizer’s vaccine is expected to be followed soon by one for Moderna’s version, which uses similar technology and has also shown promising results in clinical trials. Operation Warp Speed, the Trump administration’s multi-billion-dollar program to fast-track vaccine development, pre-ordered 100 million doses of Pfizer’s vaccine in July and heavily backed the development and manufacturing of Moderna’s vaccine.

More than 100 F.D.A. employees have worked nearly round the clock to review the application Pfizer submitted on Nov. 20, compressing months of analysis into weeks as they pored over thousands of pages of clinical trial and manufacturing data.

Earlier this week, career scientists at the F.D.A. published an analysis showing the vaccine worked across a variety of demographic groups and that it was somewhat effective even after the first of two doses.

During the daylong meeting on Thursday, panel members peppered company and agency experts with detailed questions about the safety and efficacy of the vaccine, which was found to be 95 percent effective in a late-stage clinical trial. Some members expressed concern that there was not enough data from 16- and 17-year-olds to know whether the vaccine would help them, but the committee decided the benefits for that group outweighed the risks.

Some members asked about the likelihood for serious allergic reactions, given the news that regulators in Britain recommended this week that people with a history of anaphylactic allergic reactions to medicines and foods not get the vaccine while they investigate two cases of allergic reactions among health care workers. Pfizer officials said there were no cases of serious allergic reactions in the trial of 44,000 participants. People with a history of allergic reactions to vaccines were excluded from the study.

One of the panel members, Dr. Paul Offit of the Children’s Hospital of Philadelphia, said he feared that statements by British regulators as well as remarks by Moncef Slaoui, a top U.S. vaccine official, could lead “tens of millions” of people with severe allergies to reject the vaccine even though evidence of a link to the shots was unclear. He asked Pfizer to conduct a separate study of people with a history of severe allergies, because “this issue is not going to die until we have better data.”

The F.D.A. said that it had asked Pfizer to include allergic reactions in its safety tracking plan and would include a warning in its instructions on the use of the vaccine.

One of the most hotly contested issues was how the broad authorization of the vaccine might affect the continuing clinical trial. Some experts have argued that, ethically, trial volunteers who received a placebo should be offered the vaccine once it is authorized, but others worried that move could tarnish the long-term results of the trial.

During the public portion of the meeting, consumer and public health advocates largely pushed the agency to authorize the vaccine, noting the urgency of the pandemic. One speaker, who identified himself as Kermit Kubitz, noted that he had no conflicts of interest to declare except for “a lot of elderly relatives.”

“They need this vaccine yesterday,” he said.

But advocates also asked regulators to be transparent about potential safety issues and to closely track the vaccine once it becomes available. Several said such measures were necessary to reassure a public that is hesitant to take a new vaccine, particularly Black and Native American people who have historically been mistreated by the medical community. “Before authorization is granted, affected communities need to have confidence that the vaccine is safe and effective,” said Sarah Christopherson of the National Women’s Health Center.

By insisting that the advisory committee vote on any vaccine, regulators created a shield against White House pressure to approve a product before the presidential election. When the panelists met in October to discuss the F.D.A.’s guidelines for approving Covid-19 vaccines, they urged the agency to take its time and cautioned that rushing the process could risk missing vital safety data and further erode public trust.

The scene that played out on Thursday — in which outside experts spent hours engaging government officials in an intense but often highly technical discussion about vaccine science — did not always make for exciting viewing. But the circumstances were certainly dramatic, as the experts were being asked to carefully weigh the risks and benefits of the vaccine, even as the United States reached the grim milestone of recording more than 3,000 Covid deaths on Wednesday and as thousands of people in Britain had already received it.

The F.D.A. has struggled, internally and externally, to move fast on its vaccine and treatment deliberations in order to curb the deadly virus’s spread — but not so fast as to undermine public confidence. It was a thin line to walk, and not helped by the torrent of troubling accusations by Mr. Trump and his advisers that the agency was moving too slowly.

Just days before Pfizer submitted its application, the company sent an enormous tranche of manufacturing data to the F.D.A. — including materials on how it was scaling up production — leaving regulators scrambling to evaluate it in time for a possible authorization.

As part of its oversight, the F.D.A. also had teams review company production facilities and clinical trial sites, where they verified that records corresponded to the accounts Pfizer had submitted to federal regulators.

At the same time, regulators were evaluating an equally complex emergency authorization application submitted by Moderna, whose data will be examined publicly during another F.D.A. outside advisory meeting next week.

The Road to a Coronavirus Vaccine ›

Answers to Your Vaccine Questions

As the coronavirus vaccine get closer to U.S. authorization, here are some questions you may be wondering about:

    • If I live in the U.S., when can I get the vaccine? While the exact order of vaccine recipients may vary by state, most will likely put medical workers and residents of long-term care facilities first. If you want to understand how this decision is getting made, this article will help.
    • When can I return to normal life after being vaccinated? Life will return to normal only when society as a whole gains enough protection against the coronavirus. Once countries authorize a vaccine, they’ll only be able to vaccinate a few percent of their citizens at most in the first couple months. The unvaccinated majority will still remain vulnerable to getting infected. A growing number of coronavirus vaccines are showing robust protection against becoming sick. But it’s also possible for people to spread the virus without even knowing they’re infected because they experience only mild symptoms or none at all. Scientists don’t yet know if the vaccines also block the transmission of the coronavirus. So for the time being, even vaccinated people will need to wear masks, avoid indoor crowds, and so on. Once enough people get vaccinated, it will become very difficult for the coronavirus to find vulnerable people to infect. Depending on how quickly we as a society achieve that goal, life might start approaching something like normal by the fall 2021.
    • If I’ve been vaccinated, do I still need to wear a mask? Yes, but not forever. The two vaccines that will potentially get authorized this month clearly protect people from getting sick with Covid-19. But the clinical trials that delivered these results were not designed to determine whether vaccinated people could still spread the coronavirus without developing symptoms. That remains a possibility. We know that people who are naturally infected by the coronavirus can spread it while they’re not experiencing any cough or other symptoms. Researchers will be intensely studying this question as the vaccines roll out. In the meantime, even vaccinated people will need to think of themselves as possible spreaders.
    • Will it hurt? What are the side effects? The Pfizer and BioNTech vaccine is delivered as a shot in the arm, like other typical vaccines. The injection won’t be any different from ones you’ve gotten before. Tens of thousands of people have already received the vaccines, and none of them have reported any serious health problems. But some of them have felt short-lived discomfort, including aches and flu-like symptoms that typically last a day. It’s possible that people may need to plan to take a day off work or school after the second shot. While these experiences aren’t pleasant, they are a good sign: they are the result of your own immune system encountering the vaccine and mounting a potent response that will provide long-lasting immunity.
    • Will mRNA vaccines change my genes? No. The vaccines from Moderna and Pfizer use a genetic molecule to prime the immune system. That molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse to a cell, allowing the molecule to slip in. The cell uses the mRNA to make proteins from the coronavirus, which can stimulate the immune system. At any moment, each of our cells may contain hundreds of thousands of mRNA molecules, which they produce in order to make proteins of their own. Once those proteins are made, our cells then shred the mRNA with special enzymes. The mRNA molecules our cells make can only survive a matter of minutes. The mRNA in vaccines is engineered to withstand the cell’s enzymes a bit longer, so that the cells can make extra virus proteins and prompt a stronger immune response. But the mRNA can only last for a few days at most before they are destroyed.

Regulators sometimes received documents from the companies as late as midnight and worked through the Thanksgiving holiday. Dr. Peter Marks, the top vaccine regulator at the F.D.A., joked last week at an event hosted by the American Medical Association that his team ate turkey sandwiches while examining documents.

“Among all global regulators, we are the ones that actually don’t just look at the company’s tables. We actually get down and dirty and we look at the actual adverse event reports, the bad spelling errors that are made by physicians sometimes, et cetera,” he said at the event.

Dr. Stephen M. Hahn, the F.D.A. commissioner, kept a careful distance from the review, according to people familiar with it.

Dr. Hahn had caved to pressure earlier in the summer to authorize an old malaria drug, hydroxychloroquine, for use in Covid patients even though there was little evidence that it worked. That decision was reversed after the agency found the drug was unlikely to be effective in Covid patients and carried a risk of potentially dangerous side effects. And Dr. Hahn faced withering criticism from the scientific community after he exaggerated the benefits of another treatment, convalescent plasma, an error he later corrected.

Mr. Trump accused agency officials of being part of the “deep state” and hinted that a vaccine could come before “a very special day” — Election Day. The F.D.A.’s reputation appeared to be headed in the same direction as that of the Centers for Disease Control and Prevention, which was widely criticized for not standing up to the president.

But senior regulators — and eventually Dr. Hahn himself — pushed back. The agency’s top career officials published an opinion piece in USA Today, acknowledging that the F.D.A.’s integrity had been called into question and insisting that they would “follow the science” during the pandemic. The agency prevailed in a battle with the White House over imposing more stringent guidelines for companies developing Covid vaccines.

“In this sort of environment, where there has been so much pressure and concern, the process does provide an important check and balance,” said Dr. Jesse L. Goodman, who previously served as the F.D.A.’s chief scientist. Holding an open meeting also allows the public to “be sure that a broader scientific and clinical community is comfortable with the decision.”

On Tuesday, the president held a summit intended to showcase the administration’s role in developing a vaccine. “We are just days away from authorization from the F.D.A. and we’re pushing them hard,” Mr. Trump said at the event.

Many health care workers around the country are already raring to get the vaccine. Dr. Andrew Barros, a critical care physician in Charlottesville, Virginia, who is scheduled to get his Pfizer shot at 2:30 p.m. on Dec. 15, said he is “looking forward to having a sore arm and hopefully being one step closer to having Covid under control.”

Pfizer’s clinical trial will continue even after its vaccine is authorized by the F.D.A., and the company and F.D.A. will continue to watch for safety concerns.

Pfizer said on Thursday that it planned to apply for full approval in April of 2021, after the company had collected six months of safety data. At that point, Pfizer would be allowed to sell its vaccine directly to hospitals and other health care providers.

Carl Zimmer and Katherine J. Wu contributed reporting.

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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.”

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Business

Pfizer’s Vaccine Gives Sturdy Safety After First Dose

Pfizer’s Vaccine Offers Strong Protection After First Dose

WASHINGTON – The coronavirus vaccine, manufactured by Pfizer and BioNTech, offers strong protection against Covid-19 within about 10 days of the first dose. This emerges from documents released Tuesday by the Food and Drug Administration ahead of a meeting of their vaccine advisory group.

The result is one of several significant new results in the newsletters, which includes more than 100 pages of data analysis from the Agency and Pfizer. Last month Pfizer and BioNTech announced that their two-dose vaccine had a 95 percent effectiveness rate after two doses three weeks apart. The new analyzes show that protection starts much earlier.

In addition, the vaccine worked well regardless of the race, weight, or age of a volunteer. While no serious adverse events from the vaccine were identified in the study, many participants experienced pain, fever, and other side effects.

“This is what an A + certificate looks like for a vaccine,” said Akiko Iwasaki, an immunologist at Yale University.

On Thursday, the FDA’s Vaccine Advisory Panel will discuss these materials prior to a vote on whether to recommend approval of the vaccine by Pfizer and BioNTech.

Pfizer and BioNTech started a large-scale clinical trial in July that recruited 44,000 people in the US, Brazil and Argentina. Half of the volunteers received the vaccine and half the placebo.

New coronavirus cases in the vaccinated group of volunteers quickly subsided about 10 days after the first dose, according to a graphic in the educational materials. The number of cases increased steadily in the placebo group.

The vaccine’s swift action could benefit not only the people who receive it, but also the strained hospitals in the country, limiting the flow of new patients to intensive care units.

Despite the early protection provided by the first dose, it is unclear how long this protection would last on its own, which underscores the importance of the second dose. Previous studies have shown that the second dose of the Pfizer BioNTech vaccine gives the immune system a significant long-term boost that is seen with many other vaccines.

The effectiveness of the vaccine after the first dose, according to Dr. William C. Gruber, senior vice president of Pfizer Vaccine Clinical Research and Development, at about 52 percent. After the second dose, this value increases to about 95 percent. “Two doses of the vaccine offer maximum protection,” he said.

Many experts have raised concerns that the coronavirus vaccines might protect some people better than others. However, the results in the educational materials indicate no such problem. The vaccine has a high rate of effectiveness in both men and women, and similar rates in whites, blacks, and Latinos. It also worked well on obese people who are at higher risk of developing Covid-19.

Some vaccines for other diseases produce a weak immune response in older adults. However, Pfizer and BioNTech found that people over 65 received about as much protection from the coronavirus vaccine as younger people.

“I’ve never seen anything like it,” said Dr. Gregory Poland, a vaccine researcher at the Mayo Clinic, on the vaccine’s robust response in the overweight and elderly.

Even if the vaccine is approved by the FDA, the study will continue. In the briefing documents, the companies said they would encourage people to stay in the study for as long as possible without knowing whether they received the vaccine or the placebo, so the researchers can continue to gather information on whether the vaccine is safe and effective.

The road to a coronavirus vaccine

Interesting facts about vaccines

Confused by all of the technical terms used to describe how vaccines work and study? Let us help:

    • Adverse event: A health problem that occurs in volunteers in a clinical trial with a vaccine or drug. An adverse event is not always caused by the treatment tested in the study.
    • Antibody: A protein produced by the immune system that can attach to a pathogen such as the coronavirus and prevent it from infecting cells.
    • Approval, Licensing, and Approval for Emergency Use: Medicines, vaccines and medical devices cannot be sold in the US for no profit approval by the Food and Drug Administration, also known as Licensing. After a company submits the results of clinical studies to the FDA for review, the agency decides whether the product is safe and effective. This process usually takes many months. If the country faces an emergency – like a pandemic – a company can file an application instead Emergency approvalthat can be granted much faster.
    • Background rate: How often does the general population experience a health problem called an Adverse Event? To determine whether a vaccine or drug is safe, researchers compare the rate of adverse events in one study to the background rate.
    • Effectiveness: The benefit of a vaccine compared to a placebo, measured in a clinical trial. For example, to test a coronavirus vaccine, the researchers compare how many people in the vaccinated group and the placebo group are receiving Covid-19. In contrast, effectiveness is the benefit that a vaccine or drug offers in the real world. A vaccine’s effectiveness can be found to be less or more effective than its effectiveness.
    • Phases 1, 2 and 3 studies: Clinical trials typically take place in three phases. Phase 1 studies typically involve a few dozen people to determine whether a vaccine or drug is safe. In Phase 2 trials that involve hundreds of people, researchers can try different doses and take more measurements of the vaccine’s effects on the immune system. Phase 3 trials, involving thousands or tens of thousands of volunteers, determine the safety and effectiveness of the vaccine or medicine by waiting to see how many people are protected from the disease it is intended to be used against.
    • Placebo: A substance with no therapeutic effect that is widely used in clinical trials. For example, to see if a vaccine can prevent Covid-19, researchers can inject the vaccine into half of their volunteers while the other half are given a placebo with salt water. You can then compare how many people are infected in each group.
    • Post-market surveillance: The surveillance that occurs after a vaccine or drug has been approved and regularly prescribed by doctors. This monitoring usually confirms that the treatment is safe. Rarely, side effects are noted in certain groups of people that were overlooked during clinical trials.
    • Preclinical Research: Studies that take place prior to the start of a clinical trial typically include experiments that test a treatment on cells or animals.
    • Viral vector vaccines: A type of vaccine that uses a harmless virus to deliver immune-stimulating ingredients into the human body. Viral vectors are used in several experimental Covid-19 vaccines, including those developed by AstraZeneca and Johnson & Johnson. Both companies use a cold virus called adenovirus as a vector. The adenovirus carries coronavirus genes.
    • Test protocol: A series of procedures that must be performed during a clinical trial.

The educational materials also provide a deeper look into the safety of the vaccine. In any large clinical trial, some people who receive vaccines have health conditions unrelated to the vaccine itself. Comparing their symptom rates with those of the placebo group, as well as background rates in a population, may indicate symptoms that a vaccine may actually cause.

The FDA concluded that there were no “significant imbalances” between the two groups in serious health complications known as adverse events. The agency found that four people in the vaccinated group had a form of facial paralysis called Bell’s palsy, with no cases in the placebo group. The difference between the two groups was not significant and the rate in the vaccinated group was not significantly higher than in the general population.

The new Pfizer analysis found that many volunteers who received the vaccine felt sick in the hours after the second dose, suggesting that many people may need to request a day off or be willing to rest until symptoms appear ease up. Among the 16 to 55 year olds, more than half developed fatigue and more than half also reported headaches. Slightly more than a third experienced chills and 37 percent had muscle pain. About half of those over 55 felt tired, a third had a headache, and about a quarter felt chills, while 29 percent had muscle pain.

“Taking a day off after the second dose is a good thing to anticipate,” said Dr. Iwasaki.

On Monday, Kristen Choi, a psychiatric nurse and health care researcher at the University of California at Los Angeles, released a firsthand report on the symptoms she experienced as a participant in the Pfizer BioNTech study, including chills, nausea and headaches and fever.

“Doctors need to be prepared to discuss with patients why they should trust the vaccine and that its adverse effects could be very similar to Covid-19,” wrote Dr. Choi in JAMA Internal Medicine. She advised doctors to tell patients that these uncomfortable symptoms “are a sign that the vaccine is working despite the unfortunate similarities with the symptoms of the disease”.

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World News

Britain rolls out the Pfizer vaccine, an enormous process however an indication of hope.

Britain rolls out the Pfizer vaccine, a huge task but a sign of hope.

The UK’s National Health Service delivered its first footage of the Pfizer BioNTech Covid-19 vaccine on Tuesday. He opened a mass vaccination campaign with little precedent in modern medicine, making the British the first in the world to receive a clinically approved, fully tested vaccine for the disease.

Vaccine centers across the country are starting to carefully deliver vaccinations on a tight schedule, as the vaccine must be used or thrown away within five days of being thawed. “We do this with military precision, and indeed the military helped us with our planning,” said Fiona Kinghorn, who oversaw the launch of the vaccine at a site in Cardiff, Wales.

The effort marks a turning point in the remarkable race to manufacture a vaccine and global effort to end a pandemic that killed 1.5 million people worldwide. At a Welsh vaccination center, a retired nurse on the facility described the reaction of her youngest patient, another nurse. “She just cried and said it was such an emotional day,” she said, adding, “I think partly because she worked on a Covid ward so she saw the consequences and probably the results. Me assume she saw a lot. “

At 6:31 am Tuesday, 90-year-old Margaret Keenan, a former jeweler, rolled up the sleeve of her Merry Christmas T-shirt for the first shot, and her image quickly became a symbol of hope and resilience .

“I feel so privileged to be the first person to be vaccinated against Covid-19,” said Ms. Keenan, who lives in Coventry, Central England. “That means I can finally look forward to spending time with family and friends in the New Year after being alone for most of the year.”

UK regulators jumped ahead of their American counterparts last week to approve a coronavirus vaccine, which angered the White House and sparked a lively debate over whether the UK had moved too quickly or whether the United States was wasting valuable time when the virus was around 2,200 People killed Americans one day in the past week, as of Monday.

President Trump planned on Tuesday to issue an executive order proclaiming that other nations will not receive US vaccines until after Americans are vaccinated. This guideline seemed to have no real teeth, but it was indicative of the heated race to secure dose deliveries.

For the people who were vaccinated in the UK, including doctors and nurses who joined the country’s National Health Service this year, the footage was an early glimpse into life after the pandemic. Except for Ms. Keenan, none got as much attention as William Shakespeare, who was second in a shot in Coventry and whose real name, the National Health Service confirmed, is William Shakespeare. Twitter used the news of his vaccination as an opportunity for an enthusiastic play on words and jokes about the taming of the flu and the gentlemen of Corona.

“Today is a great day for medicine and the future,” said Chris Whitty, chief medical officer for England, on Tuesday. (A previous version of this article incorrectly stated that he was the chief medical officer for the whole of the UK.)

The first 800,000 doses of Pfizer BioNTech vaccine for the UK have been shipped from a manufacturing facility in Belgium to government warehouses in the UK and then to hospitals in the past few days.

50 hospitals will manage the admissions until the government can refine a plan for delivery to nursing homes and doctor’s offices. The vaccine must be transported in temperatures similar to the south pole before it can be stored in a regular refrigerator for five days, Pfizer said. Doctors and nurses, certain people aged 80 and over, and nursing home workers are given the vaccine first.

Some doctors and nurses have received invitations to register for appointments in the past few days. The first shots are for those who are at the highest risk of serious illness. The government has indicated that people aged 80 and over who have already had a doctor’s visit or are discharged from certain hospitals for this week will also be among the first to receive gunfire.

Nursing home residents, who should actually be the government’s top priority, will be vaccinated in the coming weeks once health officials start distributing doses across hospitals.

Hundreds of people are still dying from the virus every day in the UK, and the country has taken into account Christmas travel that scientists fear will trigger another surge in infections.

“It’s amazing to see the vaccine, but we can’t afford to relax right now,” British Prime Minister Boris Johnson said Tuesday morning when visiting a London hospital. Trying to calm a recipient’s nerves over needles, he suggested, “I always try to think of something else – recite poetry.”

Ms. Keenan, the first vaccine recipient, showed no such nerves. Nicola Sturgeon, Scotland’s first minister, said on Twitter that she had “a little lump in her throat” when Ms. Keenan was shot.

“Feels like a milestone after a tough year for everyone,” added Ms. Sturgeon.

Ms. Keenan’s shot was administered by May Parsons, a nurse originally from the Philippines who has worked for the National Health Service for 24 years.

“The past few months have been difficult for all of us who work in the NHS,” she said, “but now it feels like there is light at the end of the tunnel.”

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Health

Oxford-AstraZeneca vaccine is protected and efficient, researchers

Oxford-AstraZeneca vaccine is safe and effective, researchers

In this September 9, 2020 image, a vaccine marked with a test tube can be seen in front of the AstraZeneca logo.

Given Ruvic | Reuters

LONDON – Developed by UK pharmaceutical company AstraZeneca in partnership with Oxford University, the coronavirus vaccine is the first whose late-stage study results have been independently reviewed and published in a medical journal.

The interim results from the Phase 3 studies with the Oxford-AstraZeneca vaccine were published in the Lancet on Tuesday. Peer review means that articles or studies are reviewed by other experts in the field before they are published and serve as an additional quality control measure on the results.

The study replicated the vaccine study results published a few weeks ago, which showed an average of 70% effectiveness in protecting against the coronavirus.

The two dosage regimens used were also repeated, with the two full doses showing 62% effectiveness and 90% effectiveness shown with the half-full dosage regimen.

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World News

U.Ok. Tackles Big Vaccine Rollout After Botched Covid Response

U.K. Tackles Giant Vaccine Rollout After Botched Covid Response

LONDON – In Bristol, a sports stadium is being converted into a makeshift clinic to carry out vaccinations, as is a racetrack outside London. Village houses, libraries, and parking lots across the country are also rapidly becoming makeshift vaccination centers, with the government seeking advice from military planners.

As the UK prepares to begin rolling out a coronavirus vaccine on Tuesday, it is facing the greatest logistical challenge the country’s healthcare system has ever faced: vaccinating tens of millions of people against coronavirus in just a few months. At the same time, law enforcement agencies are grappling with a number of potential security threats to the vaccination campaign.

Healthcare retirees are being sought for help while the National Health Service recruits tens of thousands of first aid workers and other workers to administer the shot as the vaccine becomes more and more available.

“I think all people who can help should put their hands up,” said Sarah Wollaston, who worked as a doctor before serving in Parliament until recently. She has just completed part of an online refresher course to qualify for the vaccine launch.

“Physically, it’s very easy to give someone a vaccine,” she said. “The challenge is the logistics.”

As industry experts and health officials grapple with this, law enforcement officers and cyber experts face an equally pressing challenge regarding the potential security threats associated with such a high-demand product.

“It’s the world’s most precious commodity right now,” said Lisa Forte, a former UK counterintelligence officer and partner at Red Goat, a cybersecurity company. “This will of course attract highly skilled cyber criminals, criminal groups and state actors.”

Europol warned that organized crime groups could crack down on trucks with vaccines against theft and kidnapping, and Interpol last week warned of a “rush of all kinds of criminal activity related to the COVID-19 vaccine,” which it calls “liquid gold” has designated. ”

From the factory to hospitals and other locations, the Pfizer vaccine – because it must be stored at around minus 70 degrees Celsius – is acutely susceptible to sabotage in addition to theft.

“With the vaccine, the two biggest risks are maintaining the cold chain and being intercepted by public or private actors,” said Sarah Rathke, an attorney at Squire Patton Boggs, who specializes in supply chain litigation.

“It is possibly the toughest supply chain challenge in recent history as there is not much time to prepare,” added Rathke.

Cyberattacks can reveal a wealth of information about the vaccines that can be exploited by state actors and criminal gangs, experts say.

Last week, IBM announced it had discovered a number of cyberattacks against companies involved in spreading coronavirus vaccines around the world in September. IBM said the attackers, whose identities could not be established, tried to learn how the vaccines were stored and dispensed.

“We targeted petrochemical companies because they are essential for making dry ice to store the vaccine,” said Claire Zaboeva, a senior cyber threat analyst at IBM’s Security X-Force.

Ms. Zaboeva added that state actors or even terrorist groups could try to disrupt supplies as nations compete to be the first to administer the vaccine. “Making a lot of vaccine doses spoiled and useless would be a pretty devastating attack,” she said.

While security agencies address these concerns, the UK health service will face the daunting problem of managing a mass vaccination program that reaches the population farther and faster than any other public health work in living memory.

A charity, St. John Ambulance, wants to train up to 30,000 vaccines and others in vaccination centers.

“Introducing a vaccine to tens of millions of people will be a monumental task as we seek to save lives and hopefully get back to our normal way of life,” said Ian Hudspeth, chairman of the Community Wellbeing Board for the Local Government, which represents local communities .

Success is hardly guaranteed as the UK achieved few logistical results during the Covid-19 crisis. In the early stages of the pandemic, hospitals chronically lacked basic protective equipment such as masks and gloves, putting some workers at risk of infection.

Since then, the government has made efforts to put in place a testing and tracing system, even though the much-criticized project was valued at around $ 16 billion.

Pfizer’s problems in sourcing raw materials alone could mean the number of vaccine doses promised for delivery to the UK this year may be cut by half to five million. And there is a potential bottleneck in the production of dry ice that is needed to package and ship the vaccine.

However, experts are cautiously optimistic that the vaccine rollout will go better than the government’s earlier efforts to fight the pandemic, as it is handled under the umbrella of the National Health Service, which has extensive experience organizing mass vaccinations such as annual flu shots .

“It won’t be without its problems because of its size and logistics – I would be amazed if nothing went wrong anywhere in six months,” said Helen Buckingham, director of strategy and operations at the Nuffield Trust, a health research institute.

However, the concept of mass vaccination is well known, she added, “and overall people go to great lengths to do this work.”

Vaccines are sold in three different places: hospitals; Medical practices and clinics; and temporary vaccination centers that are still in preparation, including transit sites, sports stadiums, and public buildings. General practitioners, who will shoulder much of the burden, can draw on their experience of delivering at least 15 million flu vaccinations each year.

However, the coronavirus vaccination will be different for several reasons. In addition to the vaccine against Pfizer and BioNTech, the UK is likely to get at least two more approved, one from Moderna and one from AstraZeneca and the University of Oxford. But when and where everyone will be available is unclear.

Martin Marshall, Chairman of the Council of the Royal College of General Practitioners, notes that the refrigeration requirements, especially for the Pfizer and Moderna vaccines, are a complication that doctors do not have to deal with flu shots. Both require a second injection after a few weeks, which can be an administrative nightmare.

“We’re pretty used to running large vaccination programs, but of course nobody has had to do one unless vaccinations are done in pre-filled syringes,” said Marshall.

According to experts, doctor’s offices and other makeshift clinics could come into play more if the AstraZeneca vaccine is approved. Not only does it cost a lot less, but it can also be stored with normal refrigeration.

Then there are concerns that the average Briton, let alone anti-vaccination campaigners, will be reluctant to take the Pfizer and Moderna vaccines, which are based on relatively untested technology.

Priority is given to those with the highest risk and the oldest Brits. Therefore, a system is also needed to call the right people for appointments at certain times and to do this again three weeks later for the second shot.

Early plans to vaccinate nursing home residents have been postponed because of the deceptively annoying question of how to dismantle Pfizer-supplied 975-dose batches and get them safely into those facilities. And it is unclear when – and in what quantities – other vaccines will be available.

All of this has to happen at a time when the health sector is in acute strain, its staff is overwhelmed after months of relentless pressure and during a winter season when people are generally more susceptible to disease.

Even so, Mr. Marshall is confident that the introduction of the vaccine can be successful.

“I think we can do this job if we work across the NHS and show some flexibility,” he said. “It plays with the strength of the NHS, a centralized, organized and managed system – and it also plays with our values.”

Categories
Politics

Trump to signal Covid-19 vaccine government order prioritizing People

Trump to sign Covid-19 vaccine executive order prioritizing Americans

United States President Donald Trump speaks during a ceremony to present wrestler Dan Gable with the Presidential Medal of Freedom in the Oval Office of the White House in Washington, DC on December 7, 2020.

Saul Loeb | AFP | Getty Images

President Donald Trump is expected to sign an executive order on Tuesday to ensure that U.S. efforts to help other countries vaccinate their populations against Covid-19 are given a lower priority than domestic vaccinations.

In a call to reporters Monday afternoon, a senior administration official described the order primarily as “an affirmation of the President’s commitment to America First.” Additionally, the command is instructing a handful of government agencies, including the State Department and the U.S. Agency for International Development, to work together to help international partners and allies obtain Covid vaccines, the official said.

CNBC has not examined the proposed text of the Executive Ordinance, which could prove largely symbolic. The plans for the Executive Order have already been announced by Fox News.

A administration official told NBC News Monday that the schedule for providing foreign aid will be supply and demand, but is expected to begin in the second quarter. President-elect Joe Biden will take office on Jan. 20 and is likely to shape his own policy for the receipt and distribution of Covid-19 vaccines, potentially limiting the impact of Trump’s command.

Trump is expected to sign the order after making remarks at the start of a Covid-19 summit in the White House on Tuesday, a senior administration official said Monday. The event will include meetings with administrative officials and drug distributors who will discuss the process of screening and distributing vaccine candidates, the official said.

Trump has largely ignored the growing coronavirus crisis over the past few weeks despite a surge in infections and a rising death toll exceeding 2,000 deaths a day, instead focusing on legal efforts to scrap the November presidential election results .

However, the signing will take place at a particularly critical stage in vaccine development.

Trump will sign the order just days before Thursday’s Food and Drug Administration meeting to review a promising vaccine from Pfizer and German drug maker BioNTech.

This vaccine can be approved for use by the end of this week. The FDA will meet on December 17th to discuss another Moderna candidate.

While some particularly at-risk Americans may be vaccinated soon after the vaccines are approved, officials warn that it will be months before anyone who wants a vaccine gets one.

Minister of Health and Human Services Alex Azar predicted on Sunday that vaccines are unlikely to be available to everyone applying for a vaccine by the second quarter.

The Trump administration signed a deal this summer to buy 100 million doses of Pfizer’s vaccine, if it works, enough to supply 50 million Americans.

On Monday afternoon, the New York Times reported that the government had rejected an offer from Pfizer for additional doses at the time.

The Times reported, citing unnamed people familiar with the matter, that the company may have limited vaccines supply due to its commitments to other countries and may not be able to supply additional vaccines to the US until June.

A spokesman for HHS, pressured by the Times whether the government missed the opportunity to buy more of Pfizer’s vaccine, said: “We are confident that we will receive 100 million doses of Pfizer’s vaccine, as in our contract agreed and beyond that we have five other vaccine candidates. “

A Pfizer spokesman told the Times that “the company cannot comment on confidential discussions with the US government.”

The White House and HHS did not immediately provide details of the executive order. Pfizer and BioNTech did not respond to emails seeking comment.

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Categories
Health

The UK Simply Accepted the Pfizer Covid Vaccine. What Occurs Subsequent?

The UK Just Approved the Pfizer Covid Vaccine. What Happens Next?

LONDON – The first rigorously tested coronavirus vaccine was given the green light for use in the UK on Wednesday. The vaccine doses of the American pharmaceutical giant Pfizer and a small German company, BioNTech, will be injected from next week, the government said.

When the UK jumped before the United States to allow mass vaccination, it put pressure on American drug regulators, who were called to the White House by President Trump’s chief of staff on Tuesday to explain why they were unwilling to do the same.

The two countries study vaccines differently.

Rather than accepting the vaccine manufacturers’ results, American regulators are carefully re-analyzing the raw data from the studies to validate the results, considering what regulators described as thousands of pages of documents. Dr. Stephen Hahn, the commissioner for the Food and Drug Administration, said Tuesday that the FDA is “one of the few regulators in the world actually looking at the raw data.”

Regulators in the UK and other European countries rely more on in-house analysis. Instead of sifting through the raw study data and figuring out the numbers themselves, regulators often examine a drug manufacturer’s reports and, if there are no anomalies, justify their decisions in company-provided documents.

Whether the UK was rushing to approve a vaccine or whether the US was wasting valuable time as the virus kills around 1,500 Americans a day sparked a lively debate among scientists and industry experts on Wednesday. European regulators said UK approval is so limited that it only applies to certain lots of the vaccine, a claim Pfizer denied and which UK officials failed to address.

Dr. Paul Offit, a professor at the University of Pennsylvania and a member of the FDA’s Vaccine Advisory Council, said in an interview Wednesday that regulators’ success in getting vaccines approved while minimizing unforeseen errors justifies a rigorous approach.

“It is remarkable that we were able to access viruses with so few casualties,” he said, adding that American regulators were only days away from completing their own review.

The FDA has scheduled a meeting of an independent panel of experts on December 10th to review Pfizer’s vaccine. UK regulators also seek opinions from a technical committee, but this group has the flexibility to review and meet data as needed so that it can be implemented more quickly.

“In the UK, they could just say, ‘We have the data, we have the meeting,” said Stephen Evans, Professor of Pharmacoepidemiology at the London School of Hygiene & Tropical Medicine.

To speed up the process, the UK Medicines and Health Products regulator had their experts review vaccine dates as soon as they were available, and separate teams worked in parallel on different parts of the process rather than waiting for another to complete.

“If you are climbing a mountain, prepare,” said Dr. June Raine, executive director of the agency, on Wednesday. “We started this in June.”

When the first results came in on November 10, she said, “We were in base camp.” And later she said, “When we got the final analysis, we were ready for the final sprint.”

The UK has left the European Union’s regulatory orbit to get early approval for a vaccine as the bloc gives countries emergency powers in the event of a pandemic. Once the UK separates from the European Union on December 31, those vaccine-only powers will become permanent.

The countries remaining in the European Union are waiting for their regulator, the European Medicines Agency, to approve a vaccine. Like the FDA, the European regulator has scheduled a meeting on December 29th to consult outside experts and provide an opinion on the Pfizer vaccine.

The agency’s task is made more difficult by its obligation to seek the views of all 27 EU countries. This process was sped up during the pandemic, but it will be a few more days for countries to weigh in after the meeting, which will likely delay vaccinations until early January.

Pfizer plans to ship 800,000 cans to the UK in the coming days. As of Tuesday evening, these cans were being prepared for shipment at a factory in Puurs, Belgium, BioNTech said.

The cans are packaged in cardboard boxes, using dry ice to keep them at the south pole-like temperatures they need, before being placed on trucks or planes and taken to the UK. They will arrive at state distribution warehouses over the weekend, Pfizer said on Wednesday.

UK hospitals have already started emailing staff to inform them of vaccination schedules. A London hospital system states that the first doses are given on Monday at 7 a.m. The UK has placed pre-orders for 40 million doses of the Pfizer vaccine, but most of them are expected to be administered over the next year. Each patient needs two, one month apart.

A government advisory council released its list of vaccine priority groups on Wednesday. At the top of the list are residents and workers of nursing homes, followed by people over the age of 80 and health and social care workers.

In practice, however, government officials said Wednesday that they would initially limit vaccinations to a network of 50 hospitals due to the difficulty of storing and shipping the Pfizer vaccine. As a result, nurses, doctors, nursing home staff, and people 80+ who had made appointments would come first for the vaccine before residents of the nursing home.

Pfizer has said the vaccine can survive for five days in a regular refrigerator. However, the UK’s National Health Service has yet to consider issues such as staffing at locations outside the hospital and transportation difficulties within the country to decide how to administer the vaccine.

The National Health Service has around 150,000 doctors and more than 330,000 nurses and midwives.

The British decision will not in itself bring vaccinations any closer. However, Pfizer executives said Wednesday they had heard from other countries that they wanted to speed up their own approval processes in the face of UK approval.

American regulators, despite months of pressure from Mr. Trump, have claimed that they will follow their plan and review Pfizer’s vaccine to FDA standards.

The US has pre-ordered 100 million doses of the Pfizer vaccine. Most of the supply will come from a separate factory in Kalamazoo, Michigan. Still, many questions remain unanswered as to how vaccine manufacturers like Pfizer will fulfill the orders of wealthier nations that have pre-sourced supplies.