Covid-19: Testing Declines May Be Masking Real Spread of Virus in Parts of U.S. – The New York Times

Heres what you need to know:A nurse preparing a dose of the Moderna vaccine in Los Angeles on Thursday.Credit...Allison Zaucha for The New York Times

Federal regulators announced Thursday night that they had authorized Moderna to put 50 percent more coronavirus vaccine into its vials, a decision that is expected to lift the nations vaccine supply.

The decision provides new assurance of Modernas supply and could speed up its deliveries. Like Pfizer, another manufacturer of a two-dose vaccine, Moderna has pledged to deliver a total of 200 million doses by the end of May and 300 million by the end of July.

Moderna had already begun producing fuller vials in anticipation of the Food and Drug Administrations decision.

The agency told Moderna six weeks ago that it favored increasing the amount of vaccine in vials that it had previously authorized for 10 doses. In a statement, the company said it expects to begin shipping 15-dose vials within weeks.

The F.D.A.s ruling comes one day after revelations of a setback to the Biden administrations vaccine rollout. A factory mix-up ruined up to 15 million doses of Johnson & Johnsons one-shot vaccine, and has delayed F.D.A. authorization of the Baltimore plant where that vaccine is being manufactured.

Although Johnson & Johnson has said it will still be able to deliver 24 million doses this month, as promised, all shipments from that plant have been delayed while the F.D.A. investigates and decides whether to certify production lines there.

Federal officials have been counting on Johnson & Johnson to round out the nations vaccine supply. President Biden has promised enough doses for all the nations adults by the end of May.

F.D.A. regulators also decided to allow health practitioners to administer an 11th dose of Modernas vaccine if they were able to extract it out of vials previously designated for only 10 doses.

But the agency noted that unless practitioners use specialized syringes and needles, they might not to be able to extract that 11th dose. They may also be limited to only 13 shots from Modernas 15-dose vials.

Those specialized syringes have been in short supply for months.

Moderna was able to quickly modify one or more of its production lines because, while it poured more liquid into the vials, the size of vials themselves remained the same. All three of the nations federally authorized vaccine manufacturers have been able to produce more vaccine substance than they have been able to bottle in the so-called fill-and-finish phase.

In its statement, Moderna said that filling the vials with more vaccine was a way to relieve that bottleneck and accelerate production.

The mishap with Johnson & Johnsons vaccine occurred at a Baltimore plant run by Emergent BioSolutions, a subcontractor. Workers there accidentally contaminated Johnson & Johnsons doses with an ingredient used to produce a different vaccine developed by AstraZeneca. AstraZenecas vaccine has not been authorized for distribution in the United States. Emergent manufactures both vaccines at the same plant.

Federal officials attributed the mistake to human error. On Thursday, Emergent executives told employees that the entire lot of vaccine substance the equivalent of up to 15 million doses would be discarded.

Emergent issued a statement Thursday saying, Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing. The company said the error had been detected through rigorous quality checks.

Note: As of March 13, 2021. Source: Transportation Security Administration, analysis by Kevin Williams

American air travel has been picking up, but it is the small, regional, vacation-destination airports that are thriving a little more than a year after the pandemic, while large hub airports have just a fraction of the travelers they did at this time last year, detailed new data shows.

Big-city airports, including those in San Francisco, Portland and Seattle are serving between 24 percent and 46 percent of their typical traveler volume. Washington National, close to the District of Columbia, is down 70 percent in passenger volume, and Kennedy Airport in New York is serving about one-third of its normal volume, according to data from the Transportation Security Administration analyzed by Kevin Williams, a Yale economist who studies air travel.

Smaller regional airports, including those near Jackson Hole, Wyo., and Colorado ski country, have passenger volume as much as 12 percent higher than this time last year. And these airports appear to fall into two categories: those especially close to outdoor vacation destinations, and those serving communities whose residents are more willing to travel amid a pandemic.

The Centers for Disease Control and Prevention continues to advise that people refrain from widespread travel for the time being, while the agency works on travel guidance.

The current guidance addresses local gatherings where fully vaccinated people now about 16 percent of the total U.S. population return to some activities in small private settings with other fully vaccinated people, or a fully vaccinated household with one other unvaccinated household. Fully vaccinated people, the agency said, should keep following health and safety precautions in public, including wearing a mask.

But with millions of Americans getting vaccinated each day, and many states rolling back 2020-era restrictions, the drive to return to somewhat normal lifestyles is growing.

Already, some destinations, cruise lines and venues are requiring travelers to provide a C.D.C. vaccination card as proof that they have been inoculated against Covid-19. And there is great interest in a vaccine passport that would make vaccination status easy to share digitally.

The Biden administration has stayed clear of such initiatives, leaving the matter to the private sector instead.

Whats important to us and were leading an interagency process right now to go through these details are that some important criteria be met with these credentials, including equitable access and privacy and security concerns, Andy Slavitt, the acting director for the Centers for Medicare and Medicaid Services, said recently.

An updated analysis of clinical trial data shows that the Pfizer-BioNTech coronavirus vaccine continues to offer strong protection without serious safety concerns, the companies said on Thursday.

The new data also suggested that the vaccine works against a worrisome virus variant in South Africa, although more studies are needed, experts said.

Pfizer and BioNTech made the announcement in a news release. The data have not been peer-reviewed nor published in a scientific journal.

Dr. Albert Bourla, Pfizers chief executive, said in a statement that the new data confirm the favorable efficacy and safety profile of the vaccine and will allow the companies to submit an application to the Food and Drug Administration for full approval. At the moment, the vaccine has received only an emergency authorization from the agency.

The new analysis is an update to data gathered in the more than 44,000-person clinical trial that led to the authorization in the United States and in other countries in December. Pfizer and BioNTech have now recorded 927 cases of Covid-19 among participants in the study, and the new analysis finds that the vaccine is more than 91 percent effective after the second dose, given three weeks after the first.

In November, the companies said that the vaccine was 95 percent effective, a figure based on some 170 Covid-19 cases reported among participants. The new analysis found the vaccine was nearly 100 percent effective in preventing severe disease and death, as was the case in November.

More than 12,000 people who received the vaccine in the trial have passed the six-month mark since the second dose, and no new safety issues were identified, company researchers also said. The companies did not provide specific efficacy data for that group.

A virus variant first identified in South Africa has particularly worried scientists, because it carries mutations that could prevent vaccines from working as well as they do against the original coronavirus. Trials of other vaccines in South Africa, such as those developed by Johnson & Johnson and AstraZeneca, have shown that they are less effective against the so-called B.1.351 variant circulating there.

Pfizer and BioNTech said that among 800 trial participants in South Africa, all nine of the observed Covid-19 cases occurred in those who had received a placebo. Six were infected with the B.1.351 variant, suggesting that the vaccine had worked successfully to block that virus.

The companies have already announced plans to test the effectiveness of a third shot, and are also beginning a clinical trial of a new version of the vaccine that was developed specifically to target B.1.351. Moderna which, like Pfizer and BioNTech, makes a vaccine based on the mRNA platform and other companies have announced similar plans.

Natalie Dean, a biostatistician at the University of Florida, said the small number of cases in South Africa made it difficult to interpret the results. And she noted that in the United States, where variants are not yet as widespread, the new analysis concluded that the Pfizer-BioNTech vaccine was nearly 93 percent efficacious, compared to the initial estimate of 95 percent in November.

Dr. Dean said that she would need to see more details of the analysis to make any firm conclusions about that discrepancy. Some wiggle is expected in the final estimate, so I dont want to overstate this change, she said.

Pfizer and BioNTech declined to provide further details.

On Wednesday, the companies reported that a clinical trial had shown their coronavirus vaccine was almost 100 percent effective in adolescents aged 12 to 15, and caused no serious side effects. That data, too, has not yet been peer-reviewed nor published in a journal.

The Biden administration announced an advertising campaign on Thursday intended to encourage as many Americans as possible to be inoculated against the coronavirus, as deep skepticism about the vaccine remains.

The campaign, to air this month on network and cable television and online, comes as the country is moving to rapidly vaccinate Americans and as federal health officials warn against a possible fourth surge of the virus. The average number of new cases reported daily has risen about 17 percent across the country, compared with two weeks ago, according to a New York Times database.

Making equity a focus of its pandemic response, the Biden administration has added mass vaccination sites in several underserved communities. A recent survey conducted by the Kaiser Family Foundation found that the number of Americans, particularly Black adults, who want to get vaccinated has continued to increase. But it also found that vaccine skepticism remains stubbornly persistent, particularly among Republicans and white evangelical Christians. The Biden administration has flagged the issue as an impediment to achieving herd immunity and a return to normal life.

The administration is working with 275 organizations in its new public awareness push including NASCAR, the Catholic Health Association of the United States and the North American Meat Institute. The advertisements, hopeful in tone and intended as a call to action, are aimed at communities where vaccine hesitancy remains high. For example, many Catholic and evangelical groups are expected to help address religious concerns about the Johnson & Johnson vaccine, which was developed with abortion-derived fetal cell lines.

The group is collectively called the Covid-19 Community Corps, administration officials said, and participating organizations are able to reach millions of Americans who trust them.

Theyre going to listen to your words, more than they are me, as president of the United States, President Biden said Thursday on a call with faith leaders from around the country.

Administration officials said their research showed that vaccine messaging was often more persuasive coming from medical professionals and community leaders than from celebrities or the president,

The nation was averaging 2.9 million shots a day as of Thursday, according to data reported by the Centers for Disease Control and Prevention. The number has been steadily increasing as more vaccination sites have been set up and more vaccine supply became available.

We have to be honest that in some communities, there is a concern about getting vaccinated, some based on mistrust based on history, some based on just rooted in misinformation, of which there is a lot out there, Vice President Kamala Harris said Thursday during a virtual meeting about educating the public about the vaccines.

While no group is monolithic in its reasons for opposing or accepting the vaccines, the people who say they are skeptical have said they mistrust the government in general and are wary about the vaccine because it was produced quickly. Combating online misinformation remains a challenge; one fast-spreading myth is that tracker microchips are embedded in the shots.

Dr. Anthony S. Fauci, the nations leading expert on infectious diseases, explained on Wednesday that the speed in developing the virus vaccines was not a sign of rushed work.

The speed is really a reflection of decades of scientific advances that led to our being able to make a vaccine and test it so quickly, Dr. Fauci said during an interview with LL Cool J. Its been tested in tens and tens of thousands of people and it has shown a high degree of efficacy and a very, very good safety profile.

The Department of Health and Human Services has separately bought millions of dollars worth of advertising in Black and Spanish-language media, as well as in outlets that reach Asian-American and tribal communities, reinforcing the message about the safety and efficacy of coronavirus vaccines.

In early March, a New York Times analysis of state-reported race and ethnicity information showed that the vaccination rate for Black people in the United States was half that of white people, and the gap for Hispanic people was even larger. Public health experts have said that obstacles to vaccine access deserve much of the blame for those vaccination disparities.

Black and Hispanic people in the United States are less likely than their white counterparts to have internet access reliable enough to make online appointments; to have work schedules flexible enough to take any available opening; and to have access to dependable transportation to vaccine sites, among other factors. A lack of access to information about the vaccine through trusted providers can also lead to uncertainty and an unwillingness to get a shot.

For rural residents, access to the vaccine is so problematic that they see the logistics and travel time involved as simply not worth it.

Jan Hoffman contributed reporting.

Maine announced on Thursday that adults 16 years and older will be eligible for a vaccine on Wednesday, more than a week sooner than the April 19 deadline the state previously set. Virginia also announced it would allow residents 16 or older to begin getting vaccinated against Covid-19 on April 19, joining more than 40 states that have sped up efforts to open the process to all adults as federal health officials warn about a possible fourth surge of the coronavirus.

The Covid-19 vaccine is the light at the end of the tunnel, Gov. Ralph Northam said in a statement. And that light is getting brighter every day, as more and more Virginians get vaccinated.

Inoculation efforts in the United States have sped up, as states push to make more adults eligible, heeding a call from the president to rapidly expand eligibility.

Across the country, an average of 2.9 million shots a day were being administered, as of Thursday, according to data reported by the Centers for Disease Control and Prevention. About 32 percent of Virginias total population has gotten at least one shot, putting it in the top 20 states, according to a New York Times analysis of C.D.C. data. About 17 percent of Virginias total population is fully vaccinated.

Currently, in Maine, about 35 percent of the population have received at least one shot, with 20 percent of the population fully vaccinated.

On Monday, President Biden ordered his coronavirus response team to ensure that by April 19 there would be a vaccination site within five miles of 90 percent of Americans homes. It builds on his plan for states to open eligibility to all adults by May 1.

The number of Americans, in particular Black Americans, who have been vaccinated or want to to get a shot has risen significantly since January, according to a poll by the Kaiser Family Foundation. Republicans and white evangelical Christians continue to be skeptical of getting a virus vaccine, according to the survey.

The announcement by Pfizer and BioNTech this week that a clinical trial found their coronavirus vaccine to be highly effective in adolescents is good news for the 2021-22 school year.

Given the pace of adult vaccinations and the likelihood that they will lead to a decline in cases, many public health experts were already saying that schools should be planning to offer full-time in-person instruction for all grades in the fall.

Still, some teachers unions have resisted reopening schools to full capacity, even as teachers are being vaccinated. And many parents particularly parents of color have chosen to keep their students in distance learning out of fear about the virus.

Experts say the prospect that children 12 or older will probably have access to vaccines before September should reduce those concerns, and will build pressure on lagging districts to resume in-person instruction. More than anything, it increases the likelihood that middle and high schools will look more like normal in the fall.

Those schools have been more challenging to reopen than elementary schools, for two reasons: Older students are more likely than younger ones to become infected and to transmit the virus, and traditional middle and high school schedules make it difficult to keep students in stable groups.

By some estimates, fewer than half of U.S. high school students attend schools that now offer full-time in-person instruction, and as many as one in five are in schools that are still fully remote.

Dr. Jay Varma, a senior adviser for public health to Mayor Bill de Blasio of New York City, called the clinical trial results from Pfizer and BioNTech just extraordinary news, and said, It may have a really important impact on what happens with school protocols in the fall.

If many children and adolescents are vaccinated, that will also move the country closer to what scientists call herd immunity, the point at which the virus can no longer spread readily.

That if is a big one, though.

Two recent studies, neither of which has yet been peer-reviewed, found substantial vaccine hesitancy among parents of schoolchildren.

In one of the studies, concerns about the vaccine came mostly from mothers, particularly white Republican mothers.

Amid the spread of both accurate information and politicized disinformation about possible side effects, many mothers feel more capable of controlling the risks of the coronavirus itself than the risks of the coronavirus vaccine, Jessica Calarco, one of that studys authors, wrote in an opinion essay in The Washington Post.

Part of the challenge in persuading parents to vaccinate their children is that children rarely experience severe illness from the coronavirus. But experts say that it is critical to vaccinate children to achieve herd immunity and to deter new variants from emerging.

It is unclear whether schools will ultimately add the coronavirus vaccine to the list of vaccinations that students must receive to attend school.

The superintendent of the Los Angeles Unified School District, the countrys second-largest district, said in January that once Covid vaccines were available for children, vaccination would be required for students in classrooms. Unvaccinated students will continued to learn remotely.

But generally it is states, not school districts, that decide which vaccines to require, and some governors have already said they will not make coronavirus vaccines mandatory. Some experts believe that requiring them might backfire, and fuel resistance.

ISLAMABAD Pakistan said on Thursday that it would allow Covid-19 vaccine doses to be sold commercially to patients, starting with the vaccine developed in China by CanSino Biologics. The Russian Sputnik V vaccine will also be sold, officials said.

The policy will allow affluent Pakistanis to pay to get the shots at large private hospitals whenever they want, while most people wait their turn for a state-supplied vaccination.

The government will provide free vaccine to 98 percent of the people, Fawad Chaudhry, the federal minister for science and technology, said on Thursday after a meeting of the federal cabinet in Islamabad. But 2 percent of the people who dont want to wait in a line, we have decided to allow the sale of private vaccine.

The CanSino Biologics vaccine, which is administered in a single shot, will be sold for around $28 a dose, Mr. Chaudhry said.

The pricing for Sputnik V, a two-shot vaccine, is under dispute between the private company that plans to import it and the national drug regulator. Mr. Chaudhry said the company, Ali Gohar Pharmaceutical, wanted a free hand in pricing but the government could not allow that. The company has taken the matter to court in the southern province of Sindh.

On Thursday, Nadeem Akhtar, a judge of the Sindh high court, said in an interim order that any restriction relating to the sale of the Covid-19 vaccine at this stage would be against the public interest because of the undisputed urgent need due to the crisis currently being faced by the country. The next hearing of the case is scheduled for April 12.

Pakistan, with a population of more than 220 million, has reported more than 623,000 coronavirus cases and more than 14,000 deaths, according to a New York Times database. Officials said there were 53,127 active Covid cases as of Thursday, and that 98 people had died in the last 24 hours, 29 of whom were on ventilators.

President Arif Alvi; his wife, Samina Alvi; and Pervez Khattak, the defense minister, all tested positive for the virus last week. Prime Minister Imran Khan and his wife, Bushra Bibi, tested positive in March; Mr. Khan has since recovered and resumed his official duties.

The countrys public vaccination program is off to a slow start, in part because the government has not been able to secure large supplies. Officials have said they expect three million doses of the CanSino vaccine to be delivered in the next few weeks.

The government is currently giving doses of another Chinese vaccine, developed by Sinopharm, to people over the age of 60, and began registering people 50 or older for vaccination this week. But according to a major Pakistani news outlet, only about 560,000 people have been inoculated so far, out of the 17 million who are now eligible.

Critics have assailed the slow pace of the free vaccination program, and many opposition politicians and health officials have questioned the governments decision to allow private sale of the vaccine, raising concerns about affordability and potential corruption.

The governments all over the world are subsidizing the vaccine for their citizens, said Faisal Karim Kundi, a spokesman for the opposition Pakistan Peoples Party. The majority of the population is poor in the country. How will the poor afford private vaccination?

MADRID In the prelude to Easter, some in Spain are lamenting what they see as a double standard in restrictions to contain Covid-19. The polemic is echoed in other European countries, where the authorities have also tightly restricted domestic travel while allowing their citizens to go abroad and permitting foreign tourists to enter and move about more freely.

The back-and-forth over the rules reflects the difficult balancing acts for European governments trying to blunt the pandemic while keeping their economies afloat, particularly when it comes to the tourism revenues that are so critical to countries like Italy and Spain. After seven years of consecutive growth in tourism arrivals, Spain welcomed 19 million people last year, down from almost 84 million in 2019.

The Spanish government has defended its approach, stressing that visitors from most other countries do not present the same health risks as residents on the move because they must test negative for Covid-19 before traveling. But local residents do not have the option to move around the country, even if they have tested negative, for leisure.

The European Commission, the executive arm of the European Union, introduced plans recently to create a digital certificate that could ease tourism this summer, including internal travel within member states.

Given that transmission and risk are similar for national and cross-border journeys, member states should ensure there is coherence between the measures applied to the two types of journey, said Christian Wigand, a commission spokesman.

Opposition politicians in Spain seized on those comments. Some were already accusing the authorities of favoring tourists over residents seeking an Easter getaway.

Mara Jess Montero, a minister and spokeswoman for the Spanish government, said last week that the country was doing exactly the same as others in allowing foreign travel but limiting domestic movement.

Italy also has tough rules in place restricting movement across the country. Residents are allowed to leave their town or their house in the more affected regions only for work, health reasons or other reasons deemed necessities.


Covid-19: Testing Declines May Be Masking Real Spread of Virus in Parts of U.S. - The New York Times

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