Britain’s National Health Service delivered its first shots of the Pfizer-BioNTech Covid-19 vaccine on Tuesday, opening a mass vaccination campaign with little precedent in modern medicine and making Britons the first people in the world to receive a clinically authorized, fully tested vaccine.
At 6:31 a.m. Tuesday, Margaret Keenan, 90, a former jewelry shop assistant, rolled up the sleeve of her “Merry Christmas” T-shirt to receive the first shot, and her image quickly became an emblem of the remarkable race to produce a vaccine and the global effort to end a pandemic that has killed 1.5 million people worldwide.
“I feel so privileged to be the first person vaccinated against Covid-19,” said Ms. Keenan, who lives in Coventry, in central England. “It means I can finally look forward to spending time with my family and friends in the new year after being on my own for most of the year.”
British regulators leapt ahead of their American counterparts last week to authorize a coronavirus vaccine, upsetting the White House and setting off a spirited debate about whether Britain had moved too hastily, or if the United States was wasting valuable time as the virus was killing about 1,500 Americans a day.
President Trump planned on Tuesday to issue an executive order proclaiming that other nations will not get U.S. supplies of its vaccine until Americans have been inoculated, a directive that appeared to have no real teeth but nevertheless was indicative of the heated race to secure shipments of doses.
For the people receiving vaccinations in Britain, among them doctors and nurses who have fortified the country’s ailing National Health Service this year, the shots were an early glimpse at post-pandemic life. Besides Ms. Keenan, none attracted as much attention as William Shakespeare, who was second in line for a shot in Coventry and who, the National Health Service confirmed, really is named William Shakespeare.
“Today is a great day for medical science, and the future,” Chris Whitty, Britain’s chief medical officer, said on Tuesday.
The first 800,000 doses of the Pfizer-BioNTech vaccine for Britain were transported in recent days from a manufacturing plant in Belgium to government warehouses in Britain, and then to hospitals.
Fifty hospitals will be administering the shots until the government can refine a plan for delivering them at nursing homes and doctor’s offices. The vaccine must be transported at South Pole-like temperatures before it can be stored for five days in a normal refrigerator, Pfizer has said. First to receive the vaccine will be doctors and nurses, certain people aged 80 and over, and nursing home workers.
Some doctors and nurses have received invitations in recent days to sign up for appointments, with the first shots intended for those at the highest risk of severe illness. The government has indicated that people aged 80 and over who already have visits with doctors scheduled for this week, or who are being discharged from certain hospitals, will also be among the first to receive shots.
Nursing home residents, who were supposed to be the government’s top priority, will be vaccinated in the coming weeks, once health officials start distributing doses beyond hospitals.
Hundreds of people are still dying in Britain each day from the virus, and the country has made allowances for travel over the Christmas period that scientists fear will seed another uptick in infections.
“It is amazing to see the vaccine, but we can’t afford to relax now,” Prime Minister Boris Johnson of Britain said on Tuesday morning as he visited a London hospital. Trying to calm a recipient’s nerves about needles, he suggested, “I always try to think of something else — recite some poetry.”
Ms. Keenan, the first vaccine recipient, showed no such nerves. Nicola Sturgeon, Scotland’s first minister, said on Twitter that watching Ms. Keenan receive the shot gave her “a bit of a lump in the throat.”
“Feels like such a milestone moment after a tough year for everyone,” Ms. Sturgeon added.
Administering Ms. Keenan’s shot was May Parsons, a nurse who is originally from the Philippines and has worked for the National Health Service for 24 years.
“The last few months have been tough for all of us working in the N.H.S.,” she said, “but now it feels like there is light at the end of the tunnel.”
Britain’s National Health Service began delivering shots of the Pfizer-BioNTech vaccine on Tuesday, opening a public health campaign with little precedent in modern medicine.
Here is a guide to some of the basics.
Should I be concerned about the safety of the vaccine in Britain?
Britain’s drug regulator is seen as a bellwether agency, and its decisions often have influence abroad. In the case of the Pfizer vaccine, the agency has said that it did not cut any corners and undertook the same laborious process of vetting the quality, efficacy and manufacturing protocols of the vaccine.
Dr. Anthony S. Fauci, the United States’s top infectious disease expert, said last week that the British had not reviewed the vaccine “as carefully” as the United States was. But he walked back those comments the next day, saying: “I have a great deal of confidence in what the U.K. does both scientifically and from a regulator standpoint.”
Who in Britain will get the vaccine first?
Doctors and nurses, certain people 80 or over and nursing home workers.
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 be able to vaccinate only a small percentage of their citizens in the first couple of months.
Once enough people get vaccinated, it will become very difficult for the virus to find vulnerable people to infect. Life may start approaching something like normal by the fall of 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 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 virus without developing symptoms.
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 side effects. Some have felt aches and flulike symptoms that last less than a day.
Does the vaccine affect fertility?
There’s no evidence that it does, and there’s good reason to think that it does not.
Some claims have been floating around the web that coronavirus vaccines can harm a woman’s fertility. The supposed evidence rests on the fact that most coronavirus vaccines work by creating antibodies that attack the virus’s “spike” protein, and this protein has a minor resemblance to a protein crucial for the formation of the placenta.
But that does not mean that the antibodies generated by coronavirus vaccines would attack a pregnant woman’s placenta. The region of the placental protein that’s similar to spike is just too short to give the antibodies a grip.
The coronavirus vaccine made by Pfizer and BioNTech provides strong protection against Covid-19 within about 10 days of the first dose, according to documents published on Tuesday by the Food and Drug Administration before a meeting of its vaccine advisory group.
The finding is one of several significant new results featured in the briefing materials, which span 53 pages of data analyses from the agency. Last month, Pfizer and BioNTech announced that their two-dose vaccine had an efficacy rate of 95 percent after two doses administered three weeks apart. The new analyses show that the protection starts kicking in far earlier.
What’s more, the vaccine worked well regardless of a volunteer’s race, weight or age. While the trial did not find any serious adverse events caused by the vaccine, many participants did experience aches, fevers and other side effects.
On Thursday, the F.D.A.’s vaccine advisory panel will discuss these materials in advance of a vote on whether to recommend authorization of Pfizer and BioNTech’s vaccine.
Despite the early protection afforded by the first dose, it’s unclear how long that protection would last on its own, underscoring the importance of the second dose. Previous studies have found that the second dose of the Pfizer-BioNTech vaccine gives the immune system a major, long-term boost, an effect seen in many other vaccines.
Many experts have expressed concern that the coronavirus vaccines might protect some people better than others. But the results in the briefing materials indicate no such problem. The vaccine has a high efficacy rate in both men and women, as well as similar rates in white, Black and Latino people. It also worked well in obese people, who carry a greater risk of getting sick with Covid-19.
The United States has recorded its most coronavirus-related deaths over a weeklong period, as a brutal surge gathers speed across the country.
With a seven-day average of 2,249 deaths, the country broke the previous mark of 2,232 set on April 17 in the early weeks of the pandemic. Seven-day averages can provide a more accurate picture of the virus’s progression than daily death counts, which can fluctuate and disguise the broader trend line.
The United States is approaching 300,000 total deaths, with nearly 283,000 recorded, according to a New York Times database. The nation is averaging nearly 200,000 cases per day, an increase of 15 percent from the average two weeks earlier, and has recorded over 15 million total cases.
Much has changed since the previous peak in April. The coronavirus is no longer concentrated in big urban areas like New York City and now envelops much of the country, including rural areas that had avoided it for several months.
Many of the hardest-hit counties on a per person basis are now in the Midwest. North Dakota, where one in every 10 residents has contracted the virus, has the highest total reported cases by population, followed closely by South Dakota, Iowa, Wisconsin and Nebraska.
The latest wave to hit the United States has hospitalized record numbers. Each day since Dec. 2, more than 100,000 Covid-19 patients were in hospitals. That far surpasses the number of people hospitalized during the peaks spring and summer, which at their worst had nearly 60,000 Americans in the hospital daily.
The new peak also comes as the nation prepares for holiday celebrations, and as colder temperatures may push people to congregate indoors. Infectious-disease experts have warned that trends in the United States, which reported a record 2,885 deaths on Wednesday, could continue to worsen over the next several weeks.
Against the warnings of public health officials, millions of Americans traveled over the Thanksgiving holiday, stoking fears that another wave of travel could accompany this month’s celebrations.
And even without traveling far, gatherings between people from different households pose a risk.
“These are going to be perfect scenarios for replication of the virus,” said Dr. Fadi Al Akhrass, an infectious-disease specialist at Pikeville Medical Center in Kentucky.
Dr. Al Akhrass said people seemed more willing to accept the severity of the virus than they were in April, but that “everybody learned the hard way.”
“The value of Christmas is what we give, not what we take — this is something we need to consider this season,” he said. “Giving up on large gatherings will probably be the best gift of them all.”
The Trump administration is requiring states to submit personal information of people vaccinated against Covid-19 — including names, birth dates, ethnicities and addresses — raising alarms among state officials who fear that a federal vaccine registry could be misused.
The Centers for Disease Control and Prevention is instructing states to sign so-called data use agreements that commit them for the first time to sharing personal information in existing registries with the federal government. Some states, such as New York, are pushing back, either refusing to sign or signing while refusing to share the information.
Gov. Andrew M. Cuomo of New York warned that the collection of personal data could dissuade undocumented people from participating in the vaccination program. He called it “another example of them trying to extort the State of New York to get information that they can use at the Department of Homeland Security and ICE that they’ll use to deport people.”
Administration officials say that the information will not be shared with other federal agencies and that it is needed for several reasons: to ensure that people who move across state lines receive their follow-up doses; to track adverse reactions and address safety issues; and to assess the effectiveness of the vaccine among different demographic groups.
At a briefing with a small group of reporters on Monday, officials from Operation Warp Speed, the government’s vaccine initiative, defended the plan. They said all but a handful of states had signed data agreements, and the rest would sign by the end of the week, though it is not clear how many states will submit personal information.
“There is no social security number being asked for, there is no driver’s license number,” said Deacon Maddox, who runs the operation’s data and analysis system. “The only number I would say that is asked is the date of birth.”
The hurried effort at data gathering, with delivery of vaccine doses expected to begin next week, is making many immunization experts deeply uneasy. At issue is the delicate balance between a patient’s right to privacy and the government’s right to invoke its expansive authority in the name of ending the deadliest pandemic in more than a century.
Before Pfizer’s coronavirus vaccine was proved highly successful in clinical trials last month, the company offered the Trump administration the chance to lock in supplies beyond the 100 million doses the pharmaceutical maker agreed to sell the government as part of a $1.95 billion deal months ago.
But the administration, according to people familiar with the talks, never made the deal, a choice that now raises questions about whether the United States allowed other countries to take its place in line.
As the administration scrambles to try to purchase more doses of the vaccine, President Trump plans on Tuesday to issue an executive order that proclaims that other nations will not get the U.S. supplies of its vaccine until Americans have been inoculated.
But the order appears to have no real teeth and does not expand the U.S. supply of doses, according to a description of the order on Monday by senior administration officials.
The vaccine being produced by Pfizer and its German partner, BioNTech, is a two-dose treatment, meaning that 100 million doses is enough to vaccinate only 50 million Americans. The vaccine is expected to receive authorization for emergency use in the U.S. as soon as this weekend, with another vaccine, developed by Moderna, also likely to be approved for emergency use soon.
Britain plans to begin a vaccination drive on Tuesday using the Pfizer-BioNTech vaccine, making it the first Western nation to start mass vaccinations.
On Nov. 11 — two days after Pfizer first announced early results indicating that its vaccine was more than 90 percent effective — the European Union announced that it had finalized a supply deal with Pfizer and BioNTech for 200 million doses, a deal they began negotiating in months earlier. Shipments could begin by the end of the year, and the contract includes an option for 100 million more doses.
Asked if the Trump administration had missed a crucial chance to snap up more doses for Americans, a spokeswoman for the Department of Health and Human Services said, “We are confident that we will have 100 million doses of Pfizer’s vaccine as agreed to in our contract, and beyond that, we have five other vaccine candidates.”
The government was in July given the option to request 100 million to 500 million additional doses. But despite repeated warnings from Pfizer officials that demand could vastly outstrip supply and amid urges to pre-order more doses, the Trump administration turned down the offer, according to several people familiar with the discussions.
In a statement, Pfizer said that “any additional doses beyond the 100 million are subject to a separate and mutually acceptable agreement,” and that “the company is not able to comment on any confidential discussions that may be taking place with the U.S. government.”
The bulk of the global supply of vaccines has already been claimed by wealthy countries like the United States, Canada, Britain and countries in Europe, leading to criticism that people in low- and middle-income countries will be left behind. The United States has declined to participate in a global initiative, called Covax, that is meant to make a vaccine available globally.
The decision to issue the executive order was reported earlier by Fox News.
On Tuesday, a handful of people across Britain — mostly those 80 and over, health care workers and those working in nursing homes — began receiving the newly approved Pfizer vaccine. It was the first day that the inoculations were being administered in any Western nation.
Hilary Nelson, 45, an intensive care unit nurse in Scotland’s Forth Valley Royal Hospital who is also a nurse’s union representative, said it was important to get vaccinated as soon as possible.
“I want to get the vaccine to protect my colleagues, my family, but most of all the patients that we look after,” she said.
She hopes to serve as an example to others in the country, particularly those who may be doubtful of the vaccine’s safety, because she knows the heavy toll the disease has taken.
“I’ve sat with dying patients and had to call their loved ones on the phone,” she said.
“I’ve asked my questions, and I’m satisfied that it is safe.”
John Pollard, 90, was surprised to find out he was among the first patients in Britain to be offered the vaccine.
“Over the years, I’ve had all sorts of vaccinations,” he said. “I’ve never given it any thought really, all I thought was that I would like to not get Covid.” He lives on his own, so his daughter will be bringing him in for the vaccine at a hospital near his home in Brighton.
He plans to spend this Christmas at his daughter’s house, with his family around him and has high hopes for the new year: “If and when I feel if I feel fit enough, I might make a trip to Australia.”
Dr. Matt Morgan, 40, who works in the I.C.U. at University Hospital of Wales, Cardiff, has an appointment booked on Tuesday afternoon. He admitted the first Covid-19 patient to his hospital 38 weeks earlier to the day, and said things have come full circle. He was feeling “proud that science, humanity, the power of globalization, reason and truth” have produced a vaccine, ahead of his appointment Tuesday. “It’s been a very long year.”
His hospital is still dealing with new coronavirus patients on a regular basis, and he described the second wave of infections from this fall as more like a marathon than a sprint.
While he was hopeful about the new vaccine, he worried people may mistake the start of vaccination as the end of the pandemic.
“There’s still certainly going to be people who die between now and spring,” Dr. Morgan said. “There’s still going to be families who spend Christmas alone. So, you know, this won’t in one day make everything OK.”
The new Covid-19 vaccines from Pfizer and Moderna seem to be remarkably good at preventing serious illness. But it’s unclear how well they will curb the spread of the coronavirus.
That’s because the Pfizer and Moderna trials tracked only how many vaccinated people became sick with Covid-19. That leaves open the possibility that some vaccinated people could get infected without developing symptoms, and could then silently transmit the virus.
If vaccinated people are silent spreaders of the virus, they may keep it circulating in their communities.
“A lot of people are thinking that once they get vaccinated, they’re not going to have to wear masks anymore,” said Michal Tal, an immunologist at Stanford University. “It’s really going to be critical for them to know if they have to keep wearing masks, because they could still be contagious.”
In most respiratory infections, including the new coronavirus, the nose is the main port of entry. The virus rapidly multiplies there, jolting the immune system to produce a type of antibodies that are specific to mucosa, the moist tissue lining the nose, mouth, lungs and stomach. If the same person is exposed to the virus a second time, those antibodies, as well as immune cells that remember the virus, rapidly shut down the virus in the nose before it gets a chance to take hold elsewhere in the body.
The coronavirus vaccines, in contrast, are injected deep into the muscles and are quickly absorbed into the blood, where they stimulate the immune system to produce antibodies.
Some of those antibodies will circulate to the nasal mucosa and stand guard there, but it’s not clear how much of the antibody pool can be mobilized, or how quickly. If the answer is not much, then viruses could bloom in the nose — and be sneezed or breathed out to infect others.
This is why mucosal vaccines are better than intramuscular injections at fending off respiratory viruses, experts said.
The next generation of coronavirus vaccines may elicit immunity in the nose and the rest of the respiratory tract, where it’s most needed. Or people could get an intramuscular injection followed by a mucosal boost that produces protective antibodies in the nose and throat.
In choosing a slate of doctors to testify about coronavirus treatments before his committee on Tuesday, Senator Ron Johnson, a Wisconsin Republican, has assembled a cast of witnesses who question much of the public health consensus about the virus.
That cast includes a prominent vaccine skeptic, an outspoken critic of masking and social distancing, and at least two doctors who have promoted the use of an anti-parasitic drug that government scientists have recommended against using to treat the coronavirus.
It is the latest example of how Mr. Johnson, who has used his powerful investigative panel to amplify groundless accusations pushed by President Trump, has now embraced the role of the Senate’s leading Covid contrarian.
Even as some of his Republican colleagues have sought to use their platforms to encourage Americans to take precautions against the spread of the virus and persuade the public that vaccines against it will be safe and vital, Mr. Johnson has suggested that the dangers of the coronavirus have been overblown.
And twice in the past three weeks, Mr. Johnson has used his gavel on the Homeland Security and Governmental Affairs Committee to elevate voices who public health experts say represent fringe beliefs.
It has set off something of a quiet mutiny on the panel, enraging Democrats who plan to essentially boycott the traditional cross-examination of witnesses and unsettling some Republicans who are planning to skip Tuesday’s session lest their presence be seen as lending credence to the proceeding.
The selections underscore the extent to which Mr. Johnson, a former plastics baron who has made little secret of his disdain for the Washington establishment, has eagerly echoed the most conspiracy-minded and anti-science impulses of Mr. Trump and waded headfirst into battles even the president’s usually reliable phalanx of congressional defenders have been unwilling to fight.
As some New York City school buildings reopen this week, Mayor Bill de Blasio has found himself presiding over a starkly unequal school system in which many white families have flocked back to classrooms while most families of color have chosen to learn from home indefinitely.
That gulf is illustrated in a startling statistic: There are nearly 12,000 more white children returning to public school buildings than Black students — even though there are many more Black students than white children in the system overall.
In New York and across the country, politicians and education officials have found that many nonwhite families are not ready to send their children back to classrooms, despite their struggles with remote learning, in part because of the disproportionately harsh impact the virus has had on their communities.
But the fact that so many students of color have chosen remote over in-person learning is raising alarms that existing disparities in the nation’s largest school system will widen, since remote learning has been far less effective.
New York’s issues with remote instruction begin with a lack of basic infrastructure for students learning from home. Many low-income students, including some living in homeless shelters, cannot even log on for classes because they do not have devices or Wi-Fi.
Educators also said they were scrambling to make lessons more engaging for students without much helpful guidance from the city. So while individual teachers and schools have honed creative strategies to improve online instruction, there is no citywide plan to do the same.
Latino students make up the largest share of students returning to classrooms, at about 43 percent, roughly proportional to their overall representation in the school system. But white children, who are less likely to be low-income than many of their peers, make up a quarter of students back in classrooms, even though they represent just 16 percent of overall enrollment.
Black and Asian-American families are significantly underrepresented in reopened classrooms. Just under 18 percent of Black families have chosen to send their children back to school, though those students make up nearly a quarter of the system. Asian-American children, who represent about 18 percent of the overall school system, make up the smallest share of children in classrooms this week, at just under 12 percent.
Police officers seized the computer, cellphone and hard drives of Rebekah D. Jones, an outspoken critic of Florida’s handling of coronavirus data, Ms. Jones said.
Ms. Jones, who filed a whistle-blower complaint against the state after she was fired as its virus data manager in May, said agents from the Florida Department of Law Enforcement knocked on her door at 8:30 a.m. on Monday with a search warrant.
Law enforcement officials said they were investigating unauthorized access to the Department of Health’s internal messaging system.
A brief video that Ms. Jones posted on Twitter shows agents with guns drawn and Ms. Jones, in sweatpants, telling them her husband and children were upstairs. Her children, ages 2 and 11, were still asleep, she said in an interview on Monday afternoon.
“They put a gun six inches from my face,” she said.
The agents took her computer, cellphone and other hardware, Ms. Jones said, including hard drives “that had evidence of corruption in the state.”
Ms. Jones was a geographic information systems manager in the Florida Department of Health’s division of disease control and health protection before she was fired for insubordination in May. She said her firing was retribution for refusing to manipulate coronavirus data to show that counties were ready to reopen after the state went into a lockdown. The Department of Health has denied the accusation.
Ms. Jones, who had helped create a dashboard of coronavirus data that was praised by the White House, built a rival dashboard in June with the use of public data.
In a statement, the Department of Law Enforcement said it served the warrant at Ms. Jones’s Tallahassee residence in connection to an investigation that began on Nov. 10, after Department of Health employees received an unauthorized message on their emergency alert system. The message warned employees to “speak up before another 17,000 people are dead,” The Tampa Bay Times reported last month. “You know this is wrong. You don’t have to be a part of this. Be a hero. Speak out before it’s too late.”
Gretl Plessinger, a spokeswoman for the Department of Law Enforcement, said in a statement, “Agents believe someone at the residence on Centreville Court illegally accessed the system.” She added, “Our investigation is active.”
Ms. Jones denied any involvement in the unauthorized message, asking a reporter to send her the earlier article about the incident, which she said she had not seen.
“I’m not a hacker. I wouldn’t know how to do that,” she said. “It’s data science, not computer programming.”
"time" - Google News
December 08, 2020 at 08:25PM
https://ift.tt/3lOID3a
Covid-19 News: Live Updates - The New York Times
"time" - Google News
https://ift.tt/3f5iuuC
No comments:
Post a Comment