After state and federal officials spent the first several months of the COVID-19 vaccine rollout grappling with the constrained supply of doses, a new challenge now threatens to derail the United States well-won progress inoculating its population against the society-altering disease: Demand.
While more than half of American adults have already gotten at least one shot, health experts say that reaching those who are less eager, hesitant, or simply unwilling to getting the vaccine will require even more painstaking work.
This reluctance to get vaccinated among certain U.S. populations could threaten to derail the progress and really prolong this pandemic, Evan Benjamin, a health policy and management professor at the Harvard T.H. Chan School of Public Health, told reporters during a conference call Friday, noting that roughly 20 percent of Americans are hesitant about the vaccine and another 15 percent say they definitely wont get it.
Some disease experts now think reaching full herd immunity is unlikely in the United States.
However, Benjamin doesnt believe its a lost battle.
Benjamin, who works as the chief medical officer of Boston-based health innovation center Ariadne Labs, led a team that created a toolkit for increasing public confidence in the vaccines.
Theres still progress that we could make to cut down vaccine hesitancy, he said.
According to Benjamin, reluctance to get the vaccine generally falls into three different buckets: concerns about getting sick fromthe vaccine, doubts about whether it actually offers protection, and distrust in the pharmaceutical companies and government officials that developed and approved the vaccines.
The guide looks to directly address those patient concerns, noting that the vaccines provide nearly 100 percent protection against complications from COVID-19 and that the chance of serious side effects are less than one in a million far smaller than the risk of hospitalization or death due to COVID-19 for unvaccinated individuals. It also notes that medical experts have worked on the mRNA science behind the COVID-19 vaccines for years and that they received approval so quickly due to unprecedented government investment and elimination of red tape.
The toolkit also includes best practices for medical providers looking to start those conversations with hesitant patients, from techniques like nonjudgmental listening to tips for easing into a discussion and understanding patients concerns. Polls have shown that doctors and nurses are the most trusted messengers when it comes to decisions about getting the vaccine.
The intention of the conversation guide is to tease out when people are waiting to get the vaccine and then specifically address those reasons, Benjamin said, describing the process as nudging through education. Theres even suggested language to help physicians answer over a dozen common vaccine questions.
Many people were forming opinions before theyve had conversations with their own physician, Benjamin said. And so the purpose of creating the toolkit was to make sure that actual conversations based on facts, based on listening to concerns, answering with accurate information, making sure those conversations were happening, rather than people making decisions based on anecdotes or their Facebook feeds.
To younger individuals who think they dont need to be vaccinated because their immune systems will naturally fight off infection, Benjmain said that this is much more than about you, explaining they could unknowingly catch the disease and pass it on to someone more vulnerable. He also noted that the more the virus is allowed to freely spread, the more opportunity it has to mutate.
If it mutates into something thats even more transmissible or more deadly, thats a real concern to us or not susceptible to a vaccine, Benjamin said.
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New York City plans to offer tourists a shot of the Covid-19 vaccine as part of a push to draw more foot traffic to city attractions, Mayor Bill de Blasio said Thursday.
Mobile vans would be set up to jab visitors at Central Park, the Empire State Building and other sight-seeing locations, the Democratic mayor said at a press conference. Tourists would be offered the one-shot Johnson & Johnson vaccine. Mr. de Blasio said the vaccinations would offer a positive message to people looking to travel to the city, which saw tourism plummet during the pandemic.
Come here, its safe, its a great place to be, and were going to take care of you," the mayor said.
The initiative still requires state approval because current regulations only allow people living or working in the state to get vaccinated, Mr. de Blasio said. A spokesman for New York Gov. Andrew Cuomo didnt immediately respond to a request for comment.
If approved, vaccination vans are expected to travel to Times Square, Brooklyn Bridge Park and other locations this weekend, according to the mayor.
A COVID-19 vaccine from French company Valneva has yet to complete clinical trials. But it has caught the eye of governments in the UK, Europe and Australia.
One of the vaccines main selling points is its apparent ability to mount a more general immune response against SARS-CoV-2, the virus that causes COVID-19, rather than rely on the spike protein to do this.
This means the vaccine is more likely to be effective against the type of virus variants weve already seen emerging, and may emerge in the future. Some reports describe it as variant proof.
The hope is vaccines using this technology would be able to provide protection for longer, rather than keep being reformulated to get ahead of these new variants.
Valnevas vaccine, called VLA2001, is based on tried and tested vaccine technology. Its the technology used in the vaccine against poliovirus and in some types of flu vaccines. And the company already has a commercially available Japanese encephalitis vaccine based on the same technology.
VLA2001 uses an inactivated version of the whole virus, which cannot replicate or cause disease.
The virus is inactivated using a chemical called beta-propiolactone or BPL. This is widely used to inactivate other viruses for vaccines. It was even used to make experimental versions of vaccines against SARS-CoV, the virus that caused SARS (severe acute respiratory syndrome).
This type of inactivation is expected to preserve the structure of the viral proteins, as they would occur in nature. This means the immune system will be presented with something similar to what occurs naturally, and mount a strong immune response.
Read more: From adenoviruses to RNA: the pros and cons of different COVID vaccine technologies
After being inactivated, the vaccine would be highly purified. Then, an adjuvant (an immune stimulant) is added to induce a strong immune response.
VLA2001 isnt the first inactivated vaccine against COVID-19. Leading COVID-19 inactivated vaccines, such as those developed by Sinopharm and Bharat Biotech, have been approved for use in China and received emergency approval in other countries, including India.
However, VLA2001 is the only COVID-19 vaccine candidate using whole inactivated virus in clinical trials in the UK and in mainland Europe.
This approach to vaccine development presents the immune system with all of the structural components of the SARS-CoV-2 virus, not just the spike protein, as many other COVID-19 vaccines do.
So Valnevas vaccine is thought to produce a more broadly protective immune response. That is, antibodies and cells of the immune system are able to recognise and neutralise more pieces of the virus than just the spike protein.
As a result, Valnevas vaccine could be more effective at tackling emerging COVID-19 virus variants and, if approved, play a useful role as a booster vaccine.
Valnevas vaccine can be stored at standard cold-chain conditions (2-8) and is expected to be given as two shots.
Read more: UK, South African, Brazilian: a virologist explains each COVID variant and what they mean for the pandemic
According to the company, no safety concerns or serious adverse events were associated with VLA2001 in early-stage clinical trials.
VLA2001 was given as a low, medium or high dose in these trials with all participants in the high-dose group generating antibodies to the virus spike protein.
One measure of immune response in the high-dose group after completing the two doses indicated antibody levels were, after two weeks, at least as high as those seen in patients naturally infected with SARS-CoV-2.
Interestingly, VLA2001 induced immune responses against a number of virus proteins (including the spike protein) across all participants, an encouraging sign the vaccine can provide broad protection against COVID-19.
The vaccine has since advanced to phase 3 clinical trials in the UK. The trial, which started in April 2021, will compare its safety and efficacy with the AstraZeneca vaccine.
The phase 3 trial is expected to be completed by the northern hemispheres autumn this year. And if successful, would be submitted for regulatory approval after that.
Read more: A single vaccine to beat all coronaviruses sounds impossible. But scientists are already working on one
Despite phase 3 clinical trials only just starting, the UK government has pre-ordered more than 100 million doses of the vaccine from Valneva, with the option of buying more down the track. If trials prove successful and pass regulatory approval, this means the vaccine could be used as a booster in time for this years northern hemispheres winter.
Australia has confirmed its also in talks with Valeneva about importing the vaccine. Some countries in Europe are also reportedly keen to strike a deal.
As new cases of COVID-19 increase globally, well continue to see new viral variants emerge that threaten to escape the protection existing vaccines offer.
Already, we are seeing vaccines from companies such as Moderna and Novavax begin to reformulate their spike protein-based vaccines to get ahead of emerging variants.
So Valnevas vaccine, with the potential to elicit a more broadly protective immune response, may prove to be a useful tool to combat the rise of the virus and its mutations. However, whether the vaccine is really variant proof or merely less affected by emerging variants remains to be seen.
Heres what you need to know:Christy Zahrt receiving the Pfizer vaccine at California State University, Northridge, in Los Angeles on Tuesday.Credit...Allison Zaucha for The New York Times
The Pfizer-BioNTech coronavirus vaccine is extraordinarily effective at protecting against severe disease caused by two dangerous variants, according to two studies published Wednesday.
The studies, which are based on the real-world use of the vaccine in Qatar and Israel, suggest that the vaccine can prevent the worst outcomes including severe pneumonia and death caused by B.1.1.7, the variant first identified in the U.K., and B.1.351, the variant first identified in South Africa.
This is really good news, said Dr. Annelies Wilder-Smith, an infectious disease researcher at the London School of Hygiene and Tropical Medicine. At this point in time, we can confidently say that we can use this vaccine, even in the presence of circulating variants of concern.
Previous research suggested that B.1.1.7 is more infectious and more deadly than other variants but that vaccines still worked well against it. On the other hand, vaccines appeared to be less effective against B.1.351, according to earlier studies.
One of the new studies, which appeared in the New England Journal of Medicine, is based on information about more than 200,000 people that was pulled from Qatars national Covid-19 databases between Feb. 1 and March 31.
In multiple analyses, the researchers found that the vaccine was 87 to 89.5 percent effective at preventing infection with B.1.1.7 among people who were at least two weeks past their second shot. It was 72.1 to 75 percent effective at preventing infection with B.1.351 among those who had reached the two-week point.
The vaccine was highly effective at protecting against the worst outcomes. Overall, it was 97.4 percent effective at preventing severe, critical or fatal disease from any form of the coronavirus, and 100 percent effective at preventing severe, critical or fatal disease caused by B.1.1.7 or B.1.351.
The second new study, which was published in The Lancet, was conducted by researchers at Pfizer and at Israels Ministry of Health. It is based on more than 230,000 instances of coronavirus infection that occurred in Israel between Jan. 24 and April 3. During that period, B.1.1.7 accounted for nearly 95 percent of all coronavirus cases in the country, which has vaccinated more than half of its population.
The researchers found that the vaccine was more than 95 percent effective at protecting against coronavirus infection, hospitalization and death among fully vaccinated people 16 and older. It also worked well in older adults. Among those 85 or older, the vaccine was more than 94 percent effective at preventing infection, hospitalization and death.
Gov. Andrew M. Cuomo of New York announced on Wednesday that baseball fans who have been fully vaccinated against the coronavirus will soon be able to enjoy seating arrangements without social distancing at Yankee Stadium and Citi Field, and that spectators who get vaccinated at either stadium during a game will get a free ticket.
Beginning on May 19, the same day the state is ending most capacity restrictions for businesses, fully vaccinated people will be allowed to sit in sections of the stadiums where every seat can be occupied, though they will have to wear masks. They can also be accompanied by children who are under 16 and unvaccinated, who must also wear masks.
People who have not been vaccinated will sit in sections where only one-third of the seats can be occupied, and will have to observe six-foot social distancing rules. Both Yankee Stadium and Citi Field, the home of the Mets, are mass vaccination sites, and both stadiums will offer a voucher for a free ticket to people who are vaccinated there on game days, as an incentive to receive the vaccine.
You take a vaccine shot, get a voucher, you can go to that game, Randy Levine, the president of the New York Yankees, said at Mr. Cuomos news conference. If that games sold out, you can go tomorrow night, go to a game of your choice.
The Johnson & Johnson vaccine, which only requires one shot, will be offered to game attendees, the governor said, so they will not have to schedule a follow-up appointment.
Social distancing, capacity rules and other safety measures vary significantly from one Major League stadium to another, because of differing local regulations and individual team decisions.
Mr. Cuomo also announced that Broadway shows would start selling tickets on Thursday for full-capacity shows with performances starting Sept. 14.
Broadway, home to 41 theaters with between 600 and 1,900 seats, drew 14.6 million people who spent $1.758 billion on tickets in 2019. The pandemic had forced them all to close since March 12, 2020, and reopening is clearly going to be far more complicated than shutting down.
With as many as eight shows a week to fill, and the tourists who make up an important part of their customer base yet to return, producers need time to advertise and market. They need to reassemble and rehearse casts who have been out of work for more than a year. And they need to sort out and negotiate safety protocols.
But the biggest reason for the delay is more gut-based: Individually and collectively, they are trying to imagine when large numbers of people will be likely to feel comfortable traveling to Times Square, funneling through cramped lobbies and walking down narrow aisles to sit shoulder to shoulder with strangers. (Most Broadway shows lose money even in the best of times, so producers say there is no way they can afford to reopen with social distancing, given the industrys high labor and real estate costs.)
The governor said that the states coronavirus indicators were all trending downward, so reopening made sense, though the state would continue monitoring the situation carefully.
According to a New York Times database, the average number of new cases a day in the state had declined by 46 percent in the past 14 days, as of Tuesday. Thirty-seven percent of the states population was fully vaccinated, as of Wednesday.
The virus does appear to be ebbing in New York City. But the city still faces challenges from uneven vaccine coverage, the slowing pace of vaccinations and the growing prevalence of variants in the city.
The coronavirus variant first discovered in New York City does not appear to be leading to more severe infections, or causing re-infections at a significantly higher rate than older forms of the virus, according to a new, preliminary analysis by city health officials that was published by the Centers for Disease and Control and Prevention on Wednesday.
The findings are the latest sign that the city may have dodged a worst-case scenario with the variant, B.1.526, as the virus seems to be ebbing in the area. Two recent laboratory studies have also shown that antibodies stimulated by the Pfizer-BioNTech and Moderna vaccines work against the variant, which is among the most common versions found in genetically analyzed cases in New York City.
However, the studys lead author underscored that the risks posed by the variant, along with other forms of the virus, including the variant first detected in Britain, B.1.1.7, remain serious, and that New Yorkers should not let down their guard even as restrictions on public life are lifted. In early April, the C.D.C. director said that the B.1.1.7 variant had become the most common source of new infections in the United States, and efforts to improve the U.S.s ability to track variants have received a significant funding boost.
The fact that the B.1.526 and the B.1.1.7 variants are circulating widely in New York City shows that they are able to compete with other variants and continue to make up a growing share of cases, Corinne Thompson, co-lead of the epidemiology data unit for the city health department, said in an email. It is critically important for New Yorkers to get vaccinated and follow public health precautions to minimize their exposure.
The B.1526 variant was first discovered circulating in Upper Manhattan in November by researchers analyzing genomes of the virus. It initially spread rapidly, rising to about 40 percent of all cases genetically sequenced in New York City by late February.
That rapid pace led researchers to conclude that the variant was more contagious that original versions, but they remained unsure if it was more serious or lethal.
In recent weeks, however, the prevalence of the B.1.526 variant has plateaued in genetically analyzed cases, even as sequencing capabilities remain limited. But the percentage of cases that are variants that scientists do believe are more dangerous including B.1.1.7, and P.1, the variant first discovered in Brazil has continued to rise.
Researchers said they were glad to see signs that the B.1.526 variant appeared to be less worrisome than B.1.1.7.
This is very reassuring, in that it is not worse than the more severe U.K. variant, in the most comprehensive analysis of our variant to date, said Denis Nash, an epidemiologist with the City University of New York, who was not involved with the study
However, the news was not all good. On Wednesday, the city released new data showing that the B.1.1.7 variant had overtaken B.1.526 in New York City, accounting for 42 percent of cases sequenced in the week of April 19-25. The P.1 variant now makes up about 4 percent of city cases. (B.1.526 dropped to 37 percent of cases.)
The new analysis published by the C.D.C. underscored the additional danger of B.1.1.7. It found that nearly 6 percent of people who were infected with that variant in New York City had been hospitalized, among cases it analyzed, compared to just over 4 percent of people with B.1.526 and other versions.
The report analyzed roughly 10,000 virus specimens in New York City taken between January 1 and April 5. Although it amounts to the most complete real world study of the genetic balance of cases in New York City to date, researchers cautioned that the data remained preliminary and limited, as only about 3 percent of all cases in the city were genetically analyzed during that period.
The report called for further study and timely genetic analysis to get a better handle on the risks.
Because relatively few specimens were sequenced over the study period, the authors wrote, the statistical power might have been insufficient to detect modest differences in rates of uncommon outcomes such as breakthrough infection or re-infection.
The State Department announced on Wednesday that it would approve the voluntary departure of nonemergency U.S. government employees in India as the country battles a second wave of coronavirus infections.
According to a travel advisory posted on the State Departments website, the agency is urging U.S. citizens to take advantage of commercial flights out of India and has also approved the voluntary departure of family members of U.S. government employees.
Indias surge in Covid-19 cases has prompted other countries to take precautions concerning who is allowed within their borders. Earlier this week Australia began a travel ban, making it a criminal offense for its citizens in India to return home a move some have condemned as overly harsh.
Last week, the Biden administration announced it would begin restricting travel from India to the United States, although restrictions will not apply to citizens or lawful permanent residents, their spouses, minor children or siblings as well as the parents of citizens or lawful permanent residents who are under 21.
Facing mounting pressure, the administration committed to exporting materials for vaccines to India along with therapeutics, rapid diagnostic test kits, ventilators and personal protective gear.
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So we have two sets of guidance. We have guidance for masking, and if youre vaccinated or unvaccinated outdoors, and we also have this camp guidance. Certainly if we have authorization for 12 to 15-year-olds, and they can get vaccinated before going to camp, thats what I would advocate for so that they can take their masks off outdoors. We also have guidance, the camp guidance and the outdoor guidance for individuals who are unvaccinated. So those who are 12 and under who are attending camp, and we have some availability of not wearing your mask outdoors in small groups, in groups with the other children who are vaccinated. What were really trying to avoid in this camp guidance is what we saw in outbreaks in camps last summer. So if you have five, 10-year-olds who are on a soccer field, all in front of the same soccer ball, were trying to make sure that theyre not a lot of heavy breathing around a singular soccer ball with five kids around it at the same time. But for spread out activities, our outdoor mass guidance for unvaccinated people small groups allows for those kids to be unvaccinated. And what we really are trying to do is ensure that all of these kids can have a really good camp experience and keep the camps open without any outbreaks.
As federal regulators prepare to authorize use of the Pfizer-BioNTech coronavirus vaccine in adolescents aged 12 to 15, a top health official said Wednesday that vaccinated individuals in that age group will be able to remove their masks outdoors at camps.
The remarks by the director of the Centers for Disease Control and Prevention, Dr. Rochelle Walensky, came after criticism that the agencys recently issued guidance for campers was needlessly strict. That guidance had said children at camps should be masked except when eating, drinking, napping or swimming.
The Pfizer vaccine is now authorized only for people 16 or older, and the two other vaccines in use now in the United States are limited to those 18 or older. But federal regulators are expected to expand the Pfizer authorization to include adolescents as soon as this week.
Dr. Walenksy said on Wednesday that the agencys guidance was intended to prevent a repeat of virus outbreaks last year that were traced to summer camps. She said that unvaccinated, unmasked children who engage in close-contact sports like soccer are at risk of transmitting the virus even when outdoors.
But she said vaccination would mitigate those risks. If we have authorization for 12- to 15-year-olds, and they can get vaccinated before going to camp, thats what I would advocate, so they can take their masks off outdoors, she said.
The C.D.C. said last week that people in the United States who are fully vaccinated no longer need to wear masks outdoors while walking, running, hiking or biking alone, or when in small gatherings with members of their own households. Masks are still necessary in crowded outdoor venues like sports stadiums, the agency said.
If the Food and Drug Administration clears the Pfizer vaccine for broader use, an advisory panel of experts would be expected to meet within a few days to make recommendation to the C.D.C. about whether to go ahead with vaccinating adolescents. The F.D.A. and the C.D.C. have shared responsibility for vaccine use.
White House officials say that the federal government is poised to make shots available for adolescents through pharmacies, pediatricians offices and other sites as soon as the health agencies act. We are prepared to move as quickly as we can after any kind of authorization, Andy Slavitt, a White House pandemic adviser, said Wednesday.
We know that kids want to go to camp this summer, he said. We know that parents want them to be safe. If they want that done without masks, vaccinations are the best answer.
The Biden administration on Wednesday came out in support of waiving intellectual property protections for Covid-19 vaccines, a breakthrough for international efforts to suspend patent rules as the pandemic rages in India and South America.
The United States had been a major holdout at the World Trade Organization over a proposal to suspend intellectual property protections in an effort to ramp up vaccine production. But President Biden had come under increasing pressure to throw his support behind the proposal, including from many congressional Democrats.
Katherine Tai, the United States trade representative, announced the administrations position in a statement on Wednesday afternoon.
This is a global health crisis, and the extraordinary circumstances of the Covid-19 pandemic call for extraordinary measures, she said. The administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for Covid-19 vaccines.
Ms. Tai added that the United States would participate in negotiations at the W.T.O. over the matter, adding, Those negotiations will take time given the consensus-based nature of the institution and the complexity of the issues involved.
Activists have been pressing for the waiver but have also said that a waiver alone will not boost world supply of the vaccine; it must be accompanied by the process known as tech transfer, in which patent holders supply technical know-how and personnel.
This is a start, said Gregg Gonsalves, a Yale University epidemiologist and longtime AIDS activist who has been pressing for the waiver. We need the writing of the text of this waiver now to be transparent and public, but as we have always said we need tech transfer now.
Earlier Wednesday, members of the W.T.O. held another round of discussions about waiving intellectual property protections. Further discussions are expected in the coming weeks, as India and South Africa, which proposed the waiver, are preparing a revised plan for nations to consider.
Ngozi Okonjo-Iweala, the director general of the W.T.O., urged members to proceed with negotiations over the text of the plan.
I am firmly convinced that once we can sit down with an actual text in front of us, we shall find a pragmatic way forward, she said at a meeting of the organizations General Council.
A federal judge on Wednesday struck down the nationwide moratorium on evictions imposed by the Trump administration last year and extended by President Biden until June 30, a ruling that could affect tenants struggling to pay rent during the pandemic.
The decision, by Judge Dabney Friedrich of the U.S. District Court for the District of Columbia, is the most significant federal ruling on the moratorium yet, and follows three similar federal court decisions. The Justice Department immediately appealed, and will seek an emergency stay of the decision, potentially delaying a final resolution of the case past the moratoriums planned June 30 expiration.
It remains unclear how wide an impact the decision will have on renters. It does not necessarily bind state housing court judges, who rule on eviction orders, and two other federal courts have upheld the moratorium, adding to the confusion about its fate.
There are now numerous conflicting court rulings at the district court level, with several judges ruling in favor of the moratorium and several ruling against, said Diane Yentel, president of the National Low Income Housing Coalition, a national tenants advocacy group.
Still, tenants rights groups said the decision on Wednesday could leave more low-income and working-class tenants vulnerable to eviction in coming weeks even as the Biden administration is beginning to disburse tens of billions of dollars in aid to help them catch up on unpaid rent.
Landlords said the decision validated their arguments that the legal basis for the federal moratorium was unsound and overstepped the governments power.
The case was brought in November by the Alabama Association of Realtors and a group of real estate agents in Georgia who claimed the moratorium shifted the burden for rent payments from the tenants to landlords at a time when many owners have been struggling to meet their own expenses.
The moratorium has had a substantial effect. Despite the sharp economic downturn created by the pandemic, eviction filings declined 65 percent in 2020 over the usual annual rate, according to an analysis of court data by the nonprofit group Eviction Lab.
Housing analysts warned that Wednesdays ruling could embolden more landlords to begin eviction proceedings against tenants before the federal government can disburse $45 billion in emergency housing assistance appropriated by Congress.
It couldnt come at a worse time, said Mary K. Cunningham, who studies housing with the Urban Institute, a nonpartisan policy group. This is happening just as communities are trying to beat the clock, waiting for the federal government to get its new housing subsidies out the door before the moratorium expires on June 30. Its terrible news.
Landlords and real estate agents downplayed concerns that lifting the moratorium will create an eviction crisis. With rental assistance secured, the economy strengthening and unemployment rates falling, there is no need to continue a blanket, nationwide eviction ban, a spokesman for the National Association of Realtors said in a statement.
The executive order covers any single renter making less than $99,000 a year and families making twice that much. About 8.2 million tenants reported that they had fallen behind in their rent payments during the pandemic, according to Census Bureau estimates.
Federal decisions, like the one issued Wednesday, are significant but serve as guidance rather than an order although an unequivocal ruling from a prominent federal court is likely to sway some local judges, said Eric Dunn, director of litigation for the National Housing Law Project, a tenant advocacy group.
A single dose of the Moderna coronavirus vaccine given as a booster rapidly increased the level of antibodies in people who had already been vaccinated, the company announced on Wednesday.
The antibodies produced by the booster were effective against the original form of the virus, as well as against the variants of concern first identified in South Africa and Brazil. A second booster specifically designed to counter B.1.351, the variant identified in South Africa, produced an even stronger immune response against that variant.
The results are from an early stage of Modernas trial of the boosters and have not yet been published or vetted by other scientists. Moderna plans to post the findings to the preprint server bioRxiv, the company said on Wednesday.
We are encouraged by these new data, which reinforce our confidence that our booster strategy should be protective against these newly detected variants, Stphane Bancel, Modernas chief executive officer, said in a statement.
The boosters, tested in 40 participants, were administered as a third shot six to eight months after the two-shot immunization with the current vaccine. Antibodies from the initial vaccination were detectable in 37 of those people, but in about half the participants, the antibodies performed poorly against the variants that have pummeled South Africa and Brazil. The boosters raised the levels of the antibodies against both variants, although the boosters were still slightly less effective than against the original form of the virus.
The mRNA platform used in the Pfizer and Moderna vaccines can be readily tweaked, enabling the companies to produce newer versions within weeks. Moderna began modifying its vaccine to combat the variant identified in South Africa, after reports emerged that the existing vaccines are slightly less effective against that variant. The variant carries a mutation that helps the virus sidestep the immune system.
Moderna is testing three strategies for enhancing the immunity produced by the current vaccine: using the current vaccine as a booster; using the booster designed specifically to combat B.1.351; and a combination of the two in a single vaccine.
Wednesdays announcement refers to results achieved two weeks after immunization with either a booster of the original vaccine or of the booster modified for B.1.351. The company plans to release data from later time points, and from tests of the combination booster, as they become available.
BOGOT, Colombia A teenager shot to death after kicking a police officer. A young man bleeding out on the street as protesters shout for help. Police officers firing on unarmed demonstrators. Helicopters swarming overhead, tanks rolling through neighborhoods, explosions echoing in the streets. A mother crying for her son.
We are destroyed, said Milena Meneses, 39, whose only son, Santiago, 19, was killed in a protest over the weekend.
Colombians demonstrating over the past week against the poverty and inequality that have worsened the lives of millions since the pandemic began have been met with a powerful crackdown by their government, which has responded to the protests with the same militarized police force it often uses against rebel fighters and organized crime.
The clashes have left at least 24 people dead, most of them demonstrators, and at least 87 missing. They have also exacerbated the anger with officials in the capital, Bogot. Protesters say the government is increasingly out of touch with peoples lives.
Experts say this explosion of frustration could presage unrest across Latin America, where several countries face the combustible mix of an unrelenting pandemic, growing hardship and plummeting government revenue.
We are all connected, said Len Valencia, a political analyst, noting that past protests had jumped from country to country. This could spread across the region.
The marches began last week after Mr. Duque proposed a tax overhaul meant to close a pandemic-related economic shortfall, and since then the crowds have grown. Demonstrators now include teachers, doctors, students, members of major unions, longtime activists and Colombians who have never before taken to the streets.
Latin America was one of the regions hardest hit by the virus last year, with cemeteries filling past capacity, the sick dying while awaiting care in hospital hallways, and family members spending the night in lines to buy medical oxygen in an attempt to keep loved ones alive.
The regions economies shrank an average of 7 percent. In many places, unemployment, particularly among the young, spiked. And in the first few months of 2021, the Covid-19 situation has worsened.
Members of the global Indian diaspora, nearly 17 million, have mobilized from afar to help back home, where the Indian health system is buckling under the weight of a devastating coronavirus wave. Here is one U.S. residents story.
One evening in late April, as the coronavirus was surging in India, Prarthana Sannamani, a Microsoft software engineer in Seattle, was growing increasingly worried about her parents, who live near the southern Indian city of Bangalore.
Gosh, Im so far away. What if my family gets sick and needs help? she recalled thinking.
Ms. Sannamani, who is in her 20s and has lived in the United States for four years, began scouring the internet and compiling a document with phone numbers for ambulances and hospitals for her parents, in case they fell ill.
But the list kept growing because I just started finding so much information, and then I thought, hey, I really want this to reach more people, she said.
Ms. Sannamani planned to share the list on Twitter, until she realized that only a small fraction of Indias 1.3 billion people used the social network, she said. One night, she came up with the idea of building a website. By the time she went to bed six hours later, at 4 a.m., Ms. Sannamani had created covidresourcesindia.com, with contact information for hospitals and emergency services in Bangalore.
Pfizer-BioNTech is seeking the Food and Drug Administration's approval for its COVID-19 vaccine, with the goal of getting the agency's green light "in the coming months." Ben Hasty/MediaNews Group/Reading Eagle via Getty Images hide caption
Pfizer-BioNTech is seeking the Food and Drug Administration's approval for its COVID-19 vaccine, with the goal of getting the agency's green light "in the coming months."
Pfizer and its vaccine partner BioNTech have started an application to request the Food and Drug Administration's approval for its COVID-19 vaccine.
Pfizer is the first coronavirus vaccine maker in the U.S. to request full approval. Like Pfizer, the Moderna and Johnson & Johnson vaccines had been previously cleared for use under the agency's emergency use authorization a less rigorous approval method to aid a swifter response to the pandemic.
An FDA approval for a vaccine means the agency has decided that its benefits outweigh the known risks following a review of the manufacturer's testing results.
If granted, Pfizer's full stamp of approval would only apply to the vaccine for people who are 16 and older. Meanwhile, the vaccine maker is seeking emergency use authorization for its COVID-19 vaccine to include children between 12 and 15.
"We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months," Pfizer CEO Albert Bourla said in a press release Friday.
BioNTech's CEO, Dr. Ugur Sahin, called the submission of the application for FDA approval "an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future."
"We are pleased to work with U.S. regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data."
In that final phase of clinical trials, Pfizer found that its vaccine was 95% effective against COVID-19, the highest efficacy among vaccines authorized for emergency use in the United States.
For the FDA to grant approval, Pfizer-BioNTech will have to comply with a key requirement: providing follow-up data six months after vaccinations.
Harrisburg, PA - The Department of Health today announced that a long-term outdoor drive-thru COVID-19 testing site will open to the public in Pike County at the Pike County Pennsylvania Welcome Center. The site is available through a partnership with AMI Expeditionary Healthcare (AMI).
The virus is still present in our communities, which is evident from the daily count of COVID-19 cases statewide, Acting Secretary of Health Alison Beam said. This reinforces the need for continued testing across the state. We encourage anyone who feels they need or want a test to take advantage of all COVID-19 testing clinics, if they think they have been exposed to COVID-19. Much of the news and attention has shifted to COVID-19 vaccines, but testing is still a critical part of our response to ultimately stop the spread of COVID-19.
Beginning Tuesday, May 11 through Saturday, June 5, testing will be available daily, Tuesdays through Saturdays from 9 AM to 6 PM at the Pike County Pennsylvania Welcome Center, 1042 Pennsylvania Avenue, Matamoras, PA, 18336.
Please note, the site will be closed on Friday, May 28 and Saturday, May 29 before Memorial Day.
Up to 450 people can be tested per day. Mid-nasal passage swab PCR tests will be performed. Testing is on a first-come, first-serve basis and is completely free. No appointment is necessary. Testing is open to individuals who are not county residents. Patients must be ages 3 and older and are not required to show symptoms of COVID-19 in order to be tested. Patients are encouraged to bring a photo-ID. Registration will also be completed on-site. The turnaround time for testing results is one to three days after testing.
The AMI testing site will be open to anyone who feels they need a test. It is important that even people with no symptoms who have tested positive isolate in order to stop the spread of COVID-19.
There are three other AMI COVID-19 testing site currently operating across the commonwealth in Centre, Delaware and Luzerne counties.
In addition, Pennsylvanians can find testing sites in their area on the locator map here.
Individuals who are tested should self-quarantine while they await their test results. Individuals who live with other people should self-quarantine in a private room and use a private bathroom, if possible. Others living in the home with the individual awaiting test results should also stay at home. The department has additional instructions for individuals waiting for a COVID-19 test result. Individuals who test positive will receive a phone call from AMI while individuals who test negative will receive a secured-PDF emailed to them from AMI.
The department believes that increased testing in counties will help determine the prevalence of the virus and assist the county in moving forward. There are currently 55 counties in the commonwealth where the percent of positive cases is above 5 percent on the Early Warning Monitoring Dashboard. Each county is being monitored as the state continues to examine all available data.
The department has contracted with AMI to perform pop-up COVID-19 testing in counties across the state since September 2020. The contracts were funded by the federal Epidemiology and Laboratory Capacity (ELC) Enhancing Detection grant. Counties under the initial contract, as well as the total number of patients tested, can be found here. Counties served under the first contract extension, as well as the total number of patients tested, can be found here.
From March 2020 through May 6, 2021, the department has received 13,330,991 polymerase chain reaction (PCR) test results. From May 2020 through May 6, 2021, the department has received 3,081,953 antigen test results. The total combined number of tests reported to the department is 16,412,944 since COVID-19 testing began in the commonwealth. The number of Pennsylvanians who have been tested by PCR or antigen tests is 5,951,782, which roughly equates to 46.5 percent of the Pennsylvania population. Some people have been tested more than once.
Counties in need of a long-term COVID-19 testing site should contact the Pennsylvania Department of Health to discuss the possibility of setting up a pop-up site through AMI.
For the latest information for individuals, families, businesses and schools, visit Responding to COVID-19 on pa.gov.
The Department of Health is working to ensure the vaccine is provided in a way that is ethical, equitable and efficient to all Pennsylvanians:
The Wolf Administration stresses the role Pennsylvanians play in helping to reduce the spread of COVID-19:
Updated Coronavirus Links: Press Releases, State Lab Photos, Graphics
MEDIA CONTACT: Barry Ciccocioppo - RA-DHpressoffice@pa.gov
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Alaskas average daily case counts are trending down statewide, with some pockets of rising case levels. A surge of coronavirus-related hospitalizations in the Fairbanks region is straining hospital capacity there; one COVID-positive patient in their 20s recently died, officials said this week. At least 23 people have tested positive in an outbreak linked to a Ketchikan wrestling tournament.
Additionally, many regions in the state are still in the highest alert category based on their current per capita rate of infection, and health officials continue to encourage Alaskans to wear face coverings in public, avoid large gatherings, wash their hands frequently and get vaccinated against COVID-19 to prevent further spread.
By Friday, there were 45 people with confirmed or suspected cases of COVID-19 in hospitals throughout the state, far below a peak in late 2020 but up compared to recent weeks.
Also by Friday, 337,630 people about 55% of all Alaskans eligible for a shot had received at least their first dose. At least 288,320 people about 48% of Alaskans 16 and older were considered fully vaccinated, according to the states vaccine monitoring dashboard.
Alaska in January led the country in per capita vaccinations, but has now fallen to 26th place among all 50 states, territories, and Washington, D.C., according to data from the U.S. Centers for Disease Control and Prevention.
You can visit covidvax.alaska.gov or call 907-646-3322 to sign up for a vaccine appointment; new appointments are added regularly. The phone line is staffed 9 a.m. to 6:30 p.m. on weekdays and 9 a.m. to 4:30 p.m. on weekends.
Of the 114 cases reported among Alaska residents on Friday, there were 34 in Anchorage, plus one in Chugiak; one in Anchor Point, one in Homer, and four in Soldotna; 13 in Fairbanks and four in North Pole; two in Delta Junction and one in Tok; one in Big Lake, two in Palmer, 13 in Wasilla, and one in Willow; three in Nome; one in Utqiagvik; five in Juneau; 17 in Ketchikan; one in Petersburg; and one in Craig.
In communities with fewer than 1,000 people not named to protect privacy, there was one in a community on the southern Kenai Peninsula, one in the Fairbanks North Star Borough, one in Southeast Fairbanks Census Area, one in Yukon-Koyukuk Census Area, one in Northwest Arctic Borough, one in Prince of Wales-Hyder Census Area, one in Yakutat plus Hoonah-Angoon, and one in Bristol Bay plus Lake and Peninsula boroughs.
There were two cases reported in nonresidents: one in Fairbanks and one in Sitka.
While people might get tested more than once, each case reported by the state health department represents only one person.
The states data doesnt specify whether people testing positive for COVID-19 have symptoms. More than half of the nations infections are transmitted from asymptomatic people, according to CDC estimates.
As countless Dallas-Fort Worth residents prepare funerals for loved ones who died of COVID-19, many are seeing extra charges related to COVID-19 sanitation and safety.
But few are aware that these fees are illegal, according to the Texas Funeral Service Commission.
Sherry Tutt of Dallas, whose mother and sister died of COVID-19 within hours of each other last year, said she plans to file a complaint with the commission over the fee she was charged.
Heres what you might see on your bill and what you should know when making funeral arrangements to avoid paying extraneous charges.
Glenn Bower, executive director of the state commission, said funeral homes cant charge customers extra for items they use to prevent the spread of COVID-19. Funeral home directors must take universal precautions for every deceased person despite their cause of death, he said.
Were supposed to ... treat every deceased person as if they were contagious, which means we use the highest level of caution as possible, Bower said. And if we put it on a price list that says, Well, we can go ahead and charge extra, that means were not taking the necessary precautions to protect ourselves, our families [and] our employees.
Bower said safety measures should be incorporated into a funeral homes basic service fee. Funeral homes can raise a service or overhead fee to accommodate COVID-19 sanitation, but its suggested that consumers file a complaint if these spikes seem unusual, he said.
Some examples of illegal charges include the use of plastic garments to contain contagious fluids or the hiring of outside services to curb community spread. It might appear as COVID-19 fee on an itemized bill.
Texas doesnt set or restrict how much funeral homes can charge for services.
Consumers in Texas, Oklahoma, Louisiana and Arkansas spent an average of $8,319 for a funeral with a viewing, casket and vault in 2019, according to the most recent data from the National Funeral Directors Association. Basic services accounted for an average of $2,000.
The state requires funeral directors to provide a general price list before funeral arrangements are made. This list should include prices for body preparation, the moving of remains and other services. Funeral homes must include contact information for the business, the date the rates and fees went into effect and a notice explaining the consumers right to refuse any services.
Cecil Dalton, owner of Dalton & Son Funeral Home in Lewisville and Flower Mound, said funeral directors must go through the itemized list with consumers line-by-line.
Depending on what type of services they choose, they can either say, Yes, we want this item, or no, we dont want this item, he said.
Under federal law, funeral homes are only required to disclose fees over the phone or when requested by a consumer.
Families have the right to decline any services funeral homes perform except a nondeclinable basic services fee.
Consumers have up to two years from the date of the alleged incident to report extraneous fees to the commission, but Bower suggests that families file complaints as soon as possible.
I would rather families file a complaint and us investigate it, as opposed to families thinking to themselves Its really not a big deal. Bower said. It is a big deal.
To make a complaint, families can send a copy of the form from the commissions official website and any supporting documents to the agencys Austin mailing address. Funeral home directors found in violation of state law may face suspension or revocation of their license.
So far, Bower said the commission hasnt received any complaints involving COVID-19 fees.
Dalton said funeral homes send insurance companies bills with the total price of services provided. Because insurers rarely ask for general price lists, except in the case of unusual deaths, he said its harder for consumers and agencies to catch wrongdoing.
If the commission rules in favor of a consumer who used insurance, the refund goes to the beneficiary listed on the plan.
Even after full vaccination against COVID-19, people who have had organ transplants are urged by their doctors to keep wearing masks and taking extra precautions. Research shows the strong drugs they must take to prevent organ rejection can significantly blunt their body's response to the vaccine. DigiPub/Getty Images hide caption
Even after full vaccination against COVID-19, people who have had organ transplants are urged by their doctors to keep wearing masks and taking extra precautions. Research shows the strong drugs they must take to prevent organ rejection can significantly blunt their body's response to the vaccine.
Laura Burns was thrilled when she got her second dose of the COVID-19 vaccine three months ago. The 71-year-old thought that with vaccination, she might finally be closer to being able to see her family in Europe again.
"I have not seen them now for two years, and that's including my stepdaughter. It's very, very ... that's hard," says Burns, who lives in Austin, Texas.
But when researchers at Johns Hopkins analyzed her blood, they couldn't detect any antibodies to the coronavirus. "I had no response whatsoever," she says. So she asked the doctors, " 'Does this mean I have no protection?' And the answer I got was, 'It means you may have no protection. You should operate on that assumption.' "
And she's not the only one.
For most people, COVID-19 vaccines promise a return to something akin to normal life. But for the hundreds of thousands of people in the U.S. who have a transplanted organ, it's a different story. That includes Burns, who got a double lung transplant nearly five years ago. New research published this week in the medical journal JAMA suggests many transplant recipients may not get protection from vaccination, even after two doses.
"Forty-six percent of transplant patients have had no evidence whatsoever that they had an antibody response to the vaccine" after two doses, Dr. Dorry Segev says. He's a transplant surgeon at Johns Hopkins and one of the authors of the study, which looked at the antibody response after full vaccination with the Moderna and Pfizer shots in more than 650 transplant recipients, including Burns.
"One of the things that we're really trying to emphasize to the transplant population is, vaccination does not mean immunity," Segev says.
And even in transplant patients who did generate an antibody response from the vaccine, he says, "it is less robust than in people with competent immune systems."
Avoiding organ rejection requires lifelong immune suppression
Valen Keefer has shown at least some antibody response and considers herself lucky. At 38, she's received not one but two organ transplants a kidney transplant at 19, and a second transplant three years ago, when her liver started failing. As is almost always the case with transplants, Keefer is on a lifelong regimen of strong daily doses of immunosuppressive drugs to keep her body from rejecting those organs.
Just this week, Keefer received test results that showed her body has produced antibodies in response to both the first and second dose of the COVID-19 vaccine though her response was weaker than that seen in people with normal immune systems.
"I'm grateful," she says. "I almost felt proud of my body. If I had two different transplants and my body could still produce antibodies, there is hope for others."
But Keefer is also confused about what the results mean in terms of her ability to navigate the world safely. "I think it's really hard to integrate back into some kind of normalcy," she says. "Transplant recipients like me, we're not sure what to do."
What about other immunocompromised patients?
The vaccine development trials did not include transplant recipients, so researchers are now trying to fill in the blanks and not just for those patients. Millions of people in the U.S. are immunocompromised. Some have medical conditions that suppress their immune systems. Others have conditions such as rheumatoid arthritis or inflammatory bowel disease that require them to be on medications that may mute their immune response to COVID-19 vaccines in varying ways, too.
For instance, Segev's study found transplant recipients will have a reduced response to vaccination if they take a class of drugs called antimetabolites. (That drug class includes mycophenolate, azathioprine and methotrexate, a medication also prescribed to some patients who have rheumatoid arthritis or lupus.) These drugs block activity in B cells the immune system's antibody factories.
Other studies have shown a reduced antibody response in patients who take Rituximab, a monoclonal antibody treatment that also targets B cells and is used to treat some cancers and autoimmune disorders.
"We know for a fact that drugs like this wipe out your B cells. ... And so it's not going to be surprising that these groups of patients aren't going to respond to the vaccines," says Ghady Haidar, a transplant infectious disease doctor at the University of Pittsburgh Medical Center.
However, he says, there are so many immunosuppressive drugs in use that, without more research, it's too soon to know which doses of which drugs in what combination might seriously blunt the benefits of COVID-19 vaccination.
The medical condition makes a difference, too. For example, Segev's research has found that the COVID-19 vaccine was more likely to work in patients with rheumatic and musculoskeletal diseases than in organ transplant recipients. And while Haidar's team failed to detect antibodies in 46% of patients with blood cancers after two doses of either the Pfizer or Moderna vaccines, researchers in the U.K. have found that patients with solid tumor cancers respond well after the second dose.
All this may leave immunocompromised individuals desperate to know whether they responded to the COVID-19 jabs they recently received, but Haidar and other experts NPR spoke with don't recommend that they seek out antibody tests on their own in part because the commercial tests available may not measure the right thing, and also because scientists have still not established what level of antibodies are required for full protection.
Booster shots down the road?
Right now, Haidar says, the best advice he can give his patients is to get vaccinated but keep living cautiously, adhering to the same masking and physical distancing precautions they've been following throughout the pandemic.
And just assume you're not protected, he advises. "I know it sounds lame, but this is all that can be offered now."
He hopes and expects that advice eventually to change as research now underway explores which factors influence the way vaccines work in immunocompromised patients. For instance, scientists are starting to explore whether the COVID-19 vaccine may be generating a response in other parts of the immune system such as among T cells that they just haven't detected yet.
"It's certainly possible that even if you have no antibodies, that your immune system is ready and waiting to respond whenever the SARS-CoV-2 virus comes, or that there might actually be an active immune response that's sort of hidden in the background," says Dr. Elad Sharon, an immunotherapy researcher at the National Cancer Institute.
It's also possible that giving immunocompromised patients a third dose of a vaccine essentially a booster shot will elicit a better antibody response. Last month, health officials in France recommended that severely immunocompromised patients receive a third dose of the Pfizer or Moderna vaccines. The vaccines aren't currently authorized for that use in the U.S., but Sharon says he eventually hopes to test that. In the meantime, some immunocompromised patients are already seeking out third shots on their own. That includes Burns.
"I just called up and explained the situation and the pharmacist gave me the Johnson & Johnson" vaccine," Burns says. She'd been vaccinated earlier with the Moderna vaccine but switched to J&J for the third dose in hopes of eliciting an antibody response by mixing and matching vaccines, a strategy embraced by some health agencies in Europe. "Knock on wood that it's going to work," Burns says. As part of the Johns Hopkins study, she'll get her levels of antibodies against the coronavirus tested again next week.
For now, though, she is still extra careful to keep from getting exposed to the coronavirus she remains mostly homebound these days. Aside from members of her household, Burns only visits with people over Zoom. When she does venture out for a quick trip to the grocery store, she'll double-mask. Masking is a familiar habit from the early months after her transplant in 2016, when the risk of organ rejection was highest, so she was on higher doses of immunosuppressive drugs. In more recent years, until the pandemic struck, she'd been able to live a much more active life, full of dinners out, indoor exercise classes and travel.
For now, scientists say the best chance that Burns and others have to be protected from getting COVID-19 is for everyone else around them to get vaccinated.
"It's yet another reason for everybody in the United States to go and get vaccinated," Segev says, "because your body can produce an immune response to protect you and all of those around you so that people whose bodies cannot produce an immune response can somehow be protected."
Keefer calls that responsibility to the community "the burden of good health."
"If you're lucky to be completely healthy," she says, "the burden of that is to step up and help protect yourself and others and get the vaccine. And that's all you have to do."
On May 6, NJCU hosted a COVID-19 Town Hall, focusing on a question and answer session to help the NJCU and Jersey City community better understand the COVID-19 vaccines available and the nation's vaccination efforts.
A panel of eight with expertise in biological sciences, biotechnology, cell biology, clinical microbiology, contact tracing, COVID-19 response, epidemiology, health science, mimunology, microbiology, molecular virology, nursing, public health, and vaccine manufacturing participated and imparted knowledge that will help individuals with questions learn more.
Watch the archived broadcast on the NJCU YouTube Channel.
Expert Panelists
Dr. Parisa Assassi, Assistant Professor/Health and Physical Education Queensborough Community College (CUNY)/Former Faculty at NJCUExpertise: Epidemiology
Dr. Meriem Bendaoud, Assistant Professor/Biology New Jersey City University Expertise: Microbiology
Dr. Gloria Boseman, Professor/NursingNew Jersey City UniversityExpertise: Nursing/Public Health
Dr. Anthony Esposito, Associate Professor/Biology New Jersey City UniversityExpertise:Molecular Virology
Stacey L. Flanagan, Director, Department of Health & Human ServicesCity of Jersey City/Adjunct Faculty Member at NJCU Expertise: Health Science/COVID Response and Contact Tracing
Dr. John Grew, Professor/BiologyNew Jersey City University Expertise: Biological Sciences, Immunology and Cell Biology
Dr.Sanjay Koul, Assistant Professor Queensborough Community College (CUNY)/Former Adjunct Faculty at NJCU Expertise: Biotechnology and Vaccine Manufacturing
Dr. Scott Mittman, Associate Dean, College of Arts and Sciences New Jersey City UniversityExpertise: Clinical Microbiology
Event ModeratorLuie Perez, 2021 Graduating SeniorNew Jersey City UniversityBachelor of Science in Public Health Education
Read the full bios of each panelist.
Contact: Ira Thor, Senior Director of University Communications and Media Relations | ithor@njcu.edu | 201-200-3301
