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Dr. Fauci says Covid vaccine trials on pregnant ladies and younger children might start 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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California Journey Restrictions: What You Have to Know

Is it restricted to travel within California?

Travel is already restricted in some areas, with additional restrictions likely. Each California county is assigned a set of restrictions based on the frequency of new virus cases and positivity. Travelers can check which activities are allowed.

According to the latest regulation, if ICU capacity falls below 15 percent in any of the five regions, people must “stay at home or where they live, unless this is required for activities related to the operation, maintenance or use of critical infrastructure is. “There are some exceptions for activities such as outdoor worship and exercise.

So far, the Southern California, Greater Sacramento, and San Joaquin Valley regions have fallen below the 15 percent threshold of the five regions in order of stay at home. Some counties, including San Francisco and Santa Clara, implemented the restrictions before they hit the threshold.

The rest of the state must adhere to the November Limited Stay Ordinance, which generally prohibits non-essential work, movement, and gatherings between 10 p.m. and 5 a.m. in counties with the highest rate of coronavirus cases and hospitalizations.

Updated

Apr 10, 2020 at 8:38 am ET

Can I get a refund on a flight to California that has already been booked?

You’ll need to check with your airline about the restrictions on your specific ticket, but most airlines have retained the newly relaxed change and cancellation rules that they put in place during the pandemic.

If you don’t get a refund, you will likely receive credit for a future flight. United Airlines’ website provides information on situations where travel plans have been affected by Covid-19. Alaska Airlines has permanently removed change fees and also offers refunds or credits if travelers’ plans change.

What if I have already booked a vacation at a California hotel?

Currently, all California hotels and accommodations, including short term rentals such as Airbnb, are prohibited from accepting or honoring reservations outside of the state for non-essential travel unless the reservation is made for the minimum quarantine period required and the guest stays there until the required time runs from.

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GPS monitoring, precedence touchdown for coronavirus vaccines, FedEx, UPS say

Wesley Wheeler, President of Global Healthcare at United Parcel Service (UPS), holds up a sample of the vial used to ship the Pfizer COVID-19 vaccine, as presented during a hearing of the Subcommittee on Commerce, Science and Transportation of the Senate testifies on logistics for shipping a COVID-19 vaccine on December 10, 2020 in Washington, DC.

Samuel Corum | Getty Images

Location tracking and priority flights are among the special treatments FedEx and United Parcel Service are planning to deliver coronavirus vaccines, executives said Thursday.

The shipping giants told a Senate transportation subcommittee that even when the busiest shipping season peaks during the holiday season, vaccines will be given priority over all other items. Richard Smith, executive vice president of FedEx Express, said the company is calling it the “Shipathon.”

Smith and Wes Wheeler, president of UPS Global Healthcare, expressed confidence that their companies could get the vaccines to administrative centers in the US and explained how they plan to divide the work.

Your comments come as federal health officials appear to be on the verge of deciding whether to accelerate approvals for Pfizer’s Covid-19 vaccine.

“Just to point out how deep this is, you have two strong rivals … in FedEx and UPS who are literally joining forces to make this happen,” said Smith. UPS also supplies materials for the vaccine kits such as diluents, syringes, and protective equipment for the medical personnel who administer the shots.

According to Wheeler from UPS, vaccine and dry ice shipments – Pfizer’s vaccine must be stored at minus 94 degrees Fahrenheit – will each have special labels with tracking technology. Vaccine shipments are also transported using devices that monitor temperature, location and movement.

He added that vaccines are loaded first and unloaded first on UPS planes. Executives said they are working with the Federal Aviation Administration to alert them to airplanes carrying the vaccine so that they can get priority take-off and landing permits.

“We are in constant communication with the aviation industry on daily command center calls and weekly calls with industry executives,” the FAA said in a statement. “We’re working with the industry to identify priority flights and prioritize our resources to meet the greatest demand.”

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F.D.A. Panel Provides Inexperienced Mild 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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Unwanted effects are indicators shot is constructing safety, says ex-FDA chief

Covid-19 vaccine side effects are signs that the shots are helping to protect against the disease, said former FDA chief Dr. Margaret Hamburg on Thursday opposite CNBC.

“The data tell us that this vaccination produces a fairly routine response at the time of administration, but it is noteworthy when you receive the vaccine,” she said on Squawk Box. “You will know when you will receive the vaccine, but that will also show you that it works and that your body is reacting,” added Hamburg, who headed the regulator in the Obama administration from 2009 to 2015.

The Hamburg statements come when the vaccine committee of the Food and Drug Administration meets on Thursday whether Pfizer and German partner BioNTech should vote for the emergency approval of the Covid-19 candidate. The non-binding decision by the panel of experts is a final step before the FDA is expected to approve the vaccine for limited use.

The agency will meet next week at the request of Massachusetts-based Moderna to obtain the same approval. The vaccine is similar to Pfizer’s in that they both take a new approach that uses genetic material to trigger an immune response.

Pfizer’s vaccine was approved by regulators in the UK last week, where the first shots for non-trial participants were given on Tuesday. However, the two allergic reactions reported by UK health workers prompted UK regulators to advise people with a history of “significant” allergic reactions to abstain from the vaccine for the time being.

Coronavirus vaccine development deadlines have been hastened this year by drug makers and governments alike in hopes of finding a solution to the devastating pandemic that killed at least 1,571,890 people worldwide, according to Johns Hopkins University. The US recorded a record 3,124 deaths on Wednesday.

Both Pfizer’s and Moderna’s vaccines were shown to be more than 94% effective in preventing symptomatic Covid-19, according to data from large-scale clinical trials.

Some of the reported side effects are “local swelling, irritation, pain, fatigue, sometimes headache,” said Hamburg. “A percentage of the patients had chills and a slight fever.”

Dr. Moncef Slaoui, who leads the Trump administration’s vaccine development efforts, has defended the safety of Pfizer and Moderna vaccines. He said earlier this month that “significantly noticeable” side effects from the admissions were reported in only 10% to 15% of study participants, which may lasted up to a day and a half.

Both Pfizer’s and Moderna’s vaccines require two doses. Some doctors have tried to raise awareness of the side effects so that vaccine recipients aren’t deterred from getting the second shot.

“We really need to make patients aware that this is not going to be a walk in the park,” said Dr. Sandra Fryhofer of the American Medical Association in November at an advisory panel meeting of the Centers for Disease Control and Prevention. “You will know you had a vaccine. You probably won’t feel wonderful. But you have to come back for that second dose.”

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Easy methods to Discuss to Youngsters About Porn

The models are hired for performance, so it is possible that it is contractual rather than consensual.

There is nothing private about it. Data protection is a healthy part of a sexual relationship.

What you see is not realistic on many levels. For example, a 10-minute sex scene can last for hours. Actors often use erectile enhancers to help maintain arousal. If a scene doesn’t come out the way you want it, just re-shoot it. If you edit afterwards, a specific representation is created.

It is relatively common for children under the age of 18 to request, take, send, and receive nudes, but this can have real ramifications. The federal government believes that child trafficking is involved even if you take and post pictures of yourself. Find out about federal laws regarding pornography and your state’s sexting laws for teenagers.

When your child tells you about an act, do your best to remain calm and resist the temptation to interrogate, be ashamed, or blame the victim. You can say, “I’m glad you came to tell me.” Focus on the person who broke trust in your child and who shares or publishes the pictures.

If the nude photos of people are posted online without their consent, the violation may appear as if it happened in person. It can be devastating. Ask what your child would like to share. Remember, abuse is a disempowering experience. We want survivors to feel they have autonomy in directing their process. Use open-ended questions and their convenience to guide the conversation. Empower them to make their own decisions by offering options and resources like therapeutic advice or reporting to law enforcement.

As a parent, you have taught your children values ​​in all aspects of their lives. Talk about how mutual respect looks, sounds, and feels in a sexual context. It is important to emphasize that sexual relationships can include both emotional and physical intimacy. The connection usually involves romantic interest and sexual attraction.

Without guidance from the adults in their lives on what pleasurable sexual experiences should look, sound and feel like, children work from what they see on screens. Make sure you provide age-appropriate, medically correct information about sexuality and instructions on how to apply that information to their intimate relationships. Encourage your children to define the gender for themselves, to avoid stereotypes affecting their actions, and to be sober and courageous in social and sexual situations.

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Pfizer-BioNTech vaccine paperwork ‘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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Social Inequities Clarify Racial Gaps in Pandemic, Research Discover

When Dr. Gbenga Ogedegbe began researching coronavirus infections in black and Hispanic patients, believed he knew what to find. Infected black and Hispanic patients would be hospitalized and dying more often compared to white patients.

But that’s not how it turned out.

Dr. Ogedegbe, the director of the Department of Health and Behavior at New York University’s Grossman School of Medicine, and colleagues reviewed the medical records of 11,547 patients in NYU’s Langone Health system between March 1 and April 8 have been tested for coronavirus infections.

After considering various differences, Dr. Ogedegbe found that infected black and Hispanic patients were no more hospitalized than white patients. Black patients had a slightly lower risk of death in the hospital.

“We were surprised,” said Dr. Ogedegbe.

The study was published in the journal JAMA Network Open. Three other recent large studies have come to similarly surprising results.

The new findings don’t contradict a massive body of research showing that black and Hispanic Americans are more likely to be affected by the pandemic compared to whites. Coronavirus is more prevalent in minority communities, and infections, diseases and deaths have emerged in disproportionate numbers in these groups.

However, the new studies suggest that there is no innate susceptibility to the virus in Black and Hispanic Americans, said Dr. Ogedegbe and other experts. Instead, these groups are more exposed due to social and ecological factors.

“We hear this all the time – ‘Blacks are more susceptible,'” said Dr. Ogedegbe. “It’s all about the exposure. It’s about where people live. It has nothing to do with genes. “

Black and Hispanic communities and households tend to be overcrowded, along with many other security vulnerabilities. Many people work in jobs that require frequent contact with others and rely on public transport. Access to health care is poorer than that of white Americans, and the basic conditions are much higher.

“To me, these results make it clear that the differences in mortality we see are even more appalling,” said Jon Zelner, an epidemiologist at the University of Michigan who led one of the new studies.

The toll on Black and Hispanic Americans “could easily have been alleviated before the pandemic through a less worn and gruesome approach to social welfare and health care in the US,” he added. “Even if it hadn’t worked, so much of it could have been avoided.”

For example, the federal government could have protected citizens from risky work situations by providing income subsidies that allowed them to stay at home, said Dr. Zelner. The government could have provided workers in nursing homes and long-term care facilities with adequate protective equipment.

Dr. From March to June, Zelner and his colleagues examined data on 49,701 coronavirus patients in Michigan who were and were not hospitalized. In this population, the death rate in black and white patients was the same: 11 percent.

(The high rate reflects the fact that Michigan incidence was dominated by the elderly at the beginning of the epidemic, Dr. Zelner said. The data pertains to detected cases rather than all infections during that period, when it was much less Tests gave.)

A study of patients in Veterans Affairs hospitals led by Dr. Christopher Rentsch of the London School of Hygiene and Tropical Medicine and VA researchers analyzed the health records of more than five million patients in more than 1,200 facilities.

About 16,317 tested positive for the coronavirus. Dr. Rentsch found that among them there was no difference in the death rate between white, black, or Hispanic patients.

The researchers had expected that underlying health conditions would result in higher death rates in Black and Hispanic patients, who are more likely to suffer from obesity and high blood pressure, which increase their risk for severe Covid-19.

However, when analyzing the death rate, these conditions “hardly moved,” said Dr. Rentsch. However, overall health differences between VA patients by race tend to be smaller than that of Americans, he warned.

A New Orleans study led by Dr. Eboni Price-Haywood, director of the Ochsner Center for Outcomes and Health Services Research, included the 3,481 patients who tested positive for the coronavirus between March 1 and April 11.

She and her colleagues found that black and white patients had the same death rate.

“It’s always confusing when people read the paper,” said Dr. Price-Haywood in an interview. But, she added, when someone was sick enough to be hospitalized, race became irrelevant.

“If you were fragile enough to be admitted, you were fragile enough to die,” said Dr. Price-Haywood.

The four studies confirmed large differences in the incidence of coronavirus infections between minority and white patients.

In the study by Dr. Ogedegbe, black and Hispanic patients were 60 to 70 percent more likely than whites to get infected. In research in Michigan, the incidence of infection in blacks was four times higher than that of whites.

“If you were to replace the white incidence rates with the black, it would reduce mortality by 83 percent,” said Dr. Zelner.

In the VA study, nine out of 1,000 white veterans had a positive coronavirus test, compared with 16.4 out of 1,000 for black patients. In New Orleans, black patients made up 76.9 percent of patients hospitalized with Covid-19, even though they made up only 31 percent of the healthcare system population.

These differences are fully explained by socioeconomic factors, researchers said.

“The bigger problem is the role of social determinants of health,” said Dr. Price-Haywood. “Race is a social construct, not a biological one.”

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White Home Coronavirus Process Pressure backs restoration of inbound journey from Brazil, UK and Europe, sources say

President Donald Trump speaks in the Rose Garden of the White House in Washington on Friday, November 13, 2020.

Evan Vucci | AP

The White House Coronavirus Task Force has recommended President Donald Trump that the United States begin admitting travelers from Brazil, the United Kingdom and the 27 countries of the European Union, according to two officials involved in the discussions.

If Trump approves the proposal for a directive, it would reverse entry bans on U.S. allies that were in place at the start of the pandemic as the virus rose overseas. Travel from China and Iran, two of the earliest hotspots for the virus that restricted travel in January and February, would not be eased, according to these officials.

The task force disagreed on its recommendation, which was sent to the president before Thanksgiving. According to the sources, the Centers for Disease Control and Prevention strongly disapproved of reopening travel as reckless, especially as the agency’s leadership signaled to the American public that domestic vacation travel was unsafe.

The proposed policy would not guarantee entry to the same countries for US travelers and would upset some of Trump’s advisors who argue that it violates the government’s “America First” mantra. However, significant disagreements persist between nations and blocs over what protocols are needed to keep transmission of the virus at bay, and the two officials who spoke with CNBC said there may be disagreements between the outbound and inbound administrations could give, which further complicates the negotiations.

In the U.S., the task force agreed that local authorities – such as individual airports, governors, and mayors – would be responsible for the testing and quarantine protocol international travelers would need after they land in order to avoid the creation of a surviving federal regulatory regime Pandemic.

The White House did not respond to a request for comment on where the political process stands and when Trump might put it into action. The two sources involved in the discussion said that if approved, they would be announced before Trump leaves office, but the growing virus as a holiday approach would challenge any announcement until then.

Reuters initially reported on the lifting of travel restrictions. The Wall Street Journal reported in October that officials were discussing a limited opening of the travel corridor between New York and London, which should go into effect before the holidays.

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‘Small City, No Hospital’: Covid-19 Is Overwhelming Rural West Texas

ALPINE, Texas – It’s one of the fastest growing coronavirus hotspots in the nation, but there are no long lines of cars piled up for drive-through tests and no rush of appointments to be wiped down at CVS.

That’s because in the rugged, rural expanse of far west Texas, there isn’t a county health department that can get daily tests and no CVS business for more than 100 miles. A handful of clinics offer tests for those who can make an appointment.

Behind the teetering oil platforms of Midland and Odessa, where real road runners scurry down two-lane roads and desert bushes freckle the long, beige horizon, the Big Bend region of Texas is one of the most remote parts of the American mainland and one of the least equipped to break out to treat infectious diseases. There is only one 12,000 square kilometer hospital and no heart or lung specialists to treat serious cases of Covid-19.

But as a sign that the virus is on the rise almost everywhere, the counties that Big Bend belongs to were in the nation’s top 20 for most new cases per capita last week.

Known for its sprawling national park and the artist town of Marfa, Big Bend provides an extreme example of the danger that is unfolding across the country as the virus flares further and more furiously than ever, driving deaths to levels seen since spring and push many places into crisis at the same time. From California to Texas to Mississippi, hospitals and health officials in rural communities are increasingly concerned that they are alone.

“There is no neurologist, there is no long-term care specialist,” said Dr. JP Schwartz, Big Bend’s Presidio County health department and a doctor at a local clinic. “We don’t want to help them at all. There isn’t even a nursing home out here. “

Even with Texas hospitalizations and deaths near their summer peaks, local officials fear they have little power to intervene beyond the measures taken by Republican Governor Greg Abbott.

“My hands are tied,” said Eleazar R. Cano, the Brewster County judge, who said he was advised against issuing a stay at home order or other stricter measures that could violate the governor’s order. Mr. Cano, a Democrat, likened governing during the pandemic to driving his truck through the desert with an empty gas tank without a cell phone operator calling for help.

“It’s helpless, frustrating, almost panicking,” he said.

On the long miles between the sparsely populated cities of Big Bend, it’s hard to fathom how a virus that thrives on human contact can flare up in a place so vast. Falcons rule in the great blue sky. Cell phone service is spotty. Christmas decorations along the street are not in people’s homes, but on the gates of their ranch.

But somehow new cases have exploded in the past few weeks.

In Brewster County, a sprawling giant of 9,200 residents in an area of ​​6,000 square miles, more than half of the 700+ known cases were identified last month. In neighboring Presidio County of 6,700 people near the Mexico border, cases have quadrupled from less than 100 to more than 470 in the past two months. Both communities are older, with 65 and over making up about a quarter of the population.

“The numbers are rising at this point,” said Malynda Richardson, the presidio city ambulance director, who coughed sporadically as she recovered from the freezing chills and knockout exhaustion of Covid-19.

There are a number of reasons for the spike.

The area is so remote that local residents have to travel to El Paso or Odessa to schedule a doctor’s appointment and buy essentials at Walmart. With cases popping up across west Texas, the virus may have come back with them. Officials also cited border traffic from Mexico, cases among young people at Sul Ross State University, and an increase in tourists who were not deterred by the pandemic.

Big Bend National Park visitor numbers rose 20 percent in October, park officials said, and so many cars clogged the park over Thanksgiving weekend that it jammed. In the liberal artist outpost of Marfa, young people from Austin and Dallas roam the city, sipping on almond milk and photographing murals that ask existential questions such as, “Is austerity an illusion?” A recent art installation caused a stir during the pandemic with an obvious message against tourism: “Everyone here hates you.”

However, it turns out that tourism isn’t the biggest part of the problem.

The limited contact tracing in the region shows greater local penetration – in bars, in multi-generational homes, and by people who ignore positive test results and continue to work and socialize as usual.

In Alpine, the largest city with 5,900 residents, residents wear masks with their cowboy hats to shop at Porter’s grocery store, but remove them to eat inside at local restaurants. There is no general consensus on whether masks are necessary and effective. In a sign of the controversy that has played out on social media and off-social media, the county was left without a local health authority when the doctor in the position, a volunteer pediatrician, resigned this fall after being told by local residents who opposed, had been pushed back mask orders and other restrictions.

Brewster County, which also includes Alpine, has already ordered bars to shut down and reduce food in indoor restaurants from 75 percent to 50 percent, as the governor’s order for counties with a high percentage of Covid-19 hospital stays prescribes. However, enforcement is incomplete, and the governor has prohibited local officials from imposing stricter rules than his own.

Because of the scarcity of resources, local health clinics are a prime option for testing, but even then, the swabs must be driven to El Paso for three hours and flown out of Dallas for processing in Arlington. The National Guard also offers regular tests. In response to the growing crisis, new mobile test vehicles should arrive this week.

For those who get seriously ill, the hospital, the Big Bend Regional Medical Center in Alpine, only has 25 beds and a makeshift Covid ward where patients were confiscated at the end of the lonely, L-shaped hallway.

Dr. John Ray, a family doctor who works shifts at the hospital, said the hospital had received consecutive calls for incoming coronavirus patients on a final day. One of them had to be taken to a larger hospital in Odessa to receive special care.

Not long after that, said Dr. Ray, he saw the patient’s obituary in the newspaper.

“I don’t want to see Alpine like the pictures you see in New York, just people dying in hallways and waiting for a bed,” said Dr. Ray, 44, who grew up in the small town of Troup, East Texas, Wisconsin for his residency and then returned to Texas to settle in the Big Bend for Beauty and People area in 2013. He and his wife, also a doctor, usually treat a lot of sore throats, urinary tract infections, and pregnancy visits. Now he said: “It’s Covid, Covid, Covid.”

Higher-level hospitals are also full across West Texas. El Paso, which was recently so inundated with infection that it created mobile morgues, is still recovering from its own virus deluge. Lubbock recently had up to 50 percent of beds filled with Covid patients, and on a particularly bad day last week, the city reported that overall hospital capacity was depleted.

Dr. Ray fears there may be a day when critically ill patients who would normally be moved to another location run out of options. “To be very clear,” he said, “if you can’t go anywhere else, you will die here.”

A spokeswoman for Big Bend Regional Medical Center said the hospital has had room so far, adding ventilators, oxygen tanks and nurses to prepare for a surge. Of nine patients in the hospital on Wednesday, four had Covid-19.

Even so, many remain concerned. Simone Rubi, 46, graphic designer and musician who owns a café in Marfa, about 30 minutes by car from the Alpine hospital, hung a poster in front of her to-go window and summarized the precarious situation in four words: “Small town, no hospital . “

“There will be no place for us if we get sick – that’s the bottom line,” she said, sitting on a picnic bench outside her shop on a Saturday morning.

“We’d have to go to Dallas,” said her husband Rob Gungor, who said he had asthma and was resigned to making the nearly eight-hour drive to an Airbnb near a major hospital if he contracted the virus to get it to be around in case it turns bad. Like most people in Marfa, who accepted masks more easily than some other cities in Big Bend, he also wore a mask outdoors.

“Maybe Phoenix,” he added, “because it’s only a nine-hour drive.”

For those living in even more rural parts of West Texas, navigating the coronavirus spike has consequences that go well beyond the virus itself.

There is only one full-service ambulance covering 3,000 square miles in the border community of Terlingua. In some cases, paramedics had to drive coronavirus patients to Alpine hospital for three hours to clear the area for other serious emergencies.

“That has always been our draw – it’s an isolated, beautiful, pristine landscape,” said Sara Allen Colando, Terlingua District Commissioner. But as the cases rise, the wilderness is also its own peril.

“If you have to take someone to God with Covid, where, how long does it take to get this ambulance back up and running?” She said. “Who will be there to take the call?”

Mitch Smith contributed to coverage from Chicago.