The Food and Drug Administration is aiming to give full authorization to the Pfizer-BioNTech coronavirus vaccine by Monday, sources familiar with the matter told the New York Times on Friday.
All coronavirus vaccines currently offered in the U.S. — produced by Pfizer and BioNTech, Moderna, and Johnson & Johnson — currently have emergency authorization from the FDA. As of Friday, 62 percent of Americans, or about 205 million residents, have received one of the three vaccines with emergency authorization. The granting of full approval of the Pfizer-BioNTech vaccine may give impetus to various public and private entities looking for greater approval from regulators to institute vaccination mandates. The Pfizer-BioNTech coronavirus vaccine was the first authorized for emergency use in the U.S., in December 2020. Former President Trump said at the time that the vaccine constituted “one of the greatest scientific accomplishments in history.”
The FDA indicated earlier this month that it would speed up the process for full approval of the coronavirus vaccines. “We recognize that for some, the FDA approval of Covid-19 vaccines may bring additional confidence and encourage them to get vaccinated,” FDA spokesperson Abby Capobianco said in a statement. “FDA staff will conduct a thorough review process, while balancing the incredible sense of urgency necessary, both of which are needed to ensure that any vaccine that is authorized or approved meets our rigorous standards for safety, effectiveness, and quality.”
The New York Times– For weeks in June and July, workers at a Maine factory making one of America’s most popular rapid tests for Covid-19 were given a task that shocked them: take apart millions of the products they had worked so hard to create and stuff them into garbage bags. Soon afterward, Andy Wilkinson, a site manager for Abbott Laboratories, the manufacturer, stood before rows of employees to announce layoffs. The company canceled contracts with suppliers and shuttered the only other plant making the test, in Illinois, dismissing a work force of 2,000. “The numbers are going down,” he told the workers of the demand for testing, saying it wasn’t their fault. “This is all about money.”
As virus cases in the U.S. plummeted this spring, so did Abbott’s Covid-testing sales. But now, amid a new surge in infections, steps the company took to eliminate stock and wind down manufacturing are proving untimely — hobbling efforts to expand screening as the highly contagious Delta variant rages across the country. Nick Bit: In July when i realized that the Delta Mutation was out of control and our vaccines were diminishing in effectiveness i panicked. That is when besides sending out our CoronaVit supplement to subscribers I frantically tried to get test kits. They had to have FDA approval our I could not import them because they had no approval and frankly all the made in India and China crap I tested was should we saydeficient. I settled on the BinaX Now test kits after Sarah was tested at the airport with this kit. I bought, paid for and ordered 1000 kits… And it was hell to get them to you. I still have another 1000 kits on back order and less then 200 in inventory . We put together a bonus package with test kits and CoronaVit supplements or ULPA nano filters and masks. We are loosing money on every order. But its not about the money… I trade for that. Click link below to see offers. SEE DISCOUNT OFFERS ON BINAX NOW CORONA TEST KITS
Demand for the 15-minute antigen test, BinaxNOW, is soaring again as people return to schools and offices. Yet Abbott has reportedly told thousands of newly interested companies that it cannot equip their testing programs in the near future. CVS, Rite Aid and Walgreens locations have been selling out of the at-home version, and Amazon shows shipping delays of up to three weeks. Abbott is scrambling to hire back hundreds of workers. America was notoriously slow in rolling out testing in the early days of the pandemic, and the story of the Abbott tests is a microcosm of the larger challenges of ensuring that the private sector can deliver the tools needed to fight public health crises, both before they happen and during the twists and turns of an actual event. “Businesses crave certainty, and pandemics don’t lend certainty to demand,” said Stephen S. Tang, chief executive of OraSure Technologies, which in the midst of the testing slump in June received emergency F.D.A. authorization for its own rapid test, InteliSwab, long in development. But the company is not yet supplying retail stores. Abbott’s decisions have ramifications even beyond the United States. Employees in Maine, many of them immigrants from African countries, were upset at having to discard what might have been donated. Other countries probably could have used the materials, according to Dr. Sergio Carmona, chief medical officer of FIND, a nonprofit that promotes access to diagnostics. “This makes me feel sick,” he said of the destruction, noting that more than a dozen African nations have no domestic funds to buy Covid tests. In an interview, Robert B. Ford, Abbott’s chief executive, argued that the discarded materials — finished test cards — should not be viewed as tests. Kits for sale also include swabs, liquid buffer and instructions. Nick Bit: This ASSHOLE can eat shit and die!. Who the fuck does he think he is? In a pandemic he starved the market to fuck us on price. They will not supply me direct and i am paying first cost as much as $25 a kit plus rip off shipping rates.. FUCK HIM IN HIS ASS. Ill be damned if i can’t out fox a corporate prick greedy scum bag. I hate them all. I will get us all the test kits we need. Testing right now is our best option. Even after the 3rd booster shot you must not let your guard down… In February when they roll out the booster shot tailored to the 3 deadly variants they can we feel safe again. In the mean time fight fight fight and survive………… CLICK HERE TO SEE DISCOUNT OFFERS ON BINAXNOW TEST KITS
An inexpensive anti-depressant curbed the number of COVID-19 patients ending up in hospital by 30 per cent, making it a potential breakthrough treatment for a virus that continues to spread widely, a Canadian-led clinical trial is reporting. The researchers looked at the rate of hospitalization among patients with test-confirmed infection. Most of the eight studied drugs, including much-debated candidates such as hydroxychloroquine and ivermectin, showed no detectable benefit. But the study found that 77 of the 739 subjects who were randomly selected to receive fluvoxamine ended up spending more than six hours in an emergency department or being admitted to hospital, compared to 108 of the 733 who were administered a placebo. The trial’s independent data-safety monitoring board, which keeps an eye on results that are blinded to the actual researchers, ordered the trial stopped after seeing the positive numbers, said Mills. It confirms smaller, earlier studies that had shown promise for the drug — used to treat obsessive-compulsive disorder — and its anti-inflammatory properties. “This is among the most important findings since the COVID pandemic began,” said Mills, a part-time professor at McMaster. “There is no other treatment for early COVID that has been shown to prevent serious disease progression.” “You have a Canadian-led study that has the potential to change guidance around the world for a very cheap treatment,” he said. “This is a massive finding of benefit to public health.” Costing about $4 per 10-day course, fluvoxamine could be especially important in poorer countries with low vaccination rates and that lack the ability to acquire more expensive therapies, he said. The researchers — including co-principal investigator Dr. Gilmar Reis of Brazil’s Pontificia Universidade Catòlica de Minas Gerais — plan to post a paper outlining their results on a pre-print site and submit it to a journal for publication within days, but so far it has yet to be peer-reviewed. They did, however, present their findings to a meeting of the National Institutes of Health (NIH) in the U.S. last week and to World Health Organization experts. And the team includes world-renowned clinical trial experts from McMaster, including Dr. Gordon Guyatt, credited with coining the term “evidence-based medicine.” Scientists not associated with the trial voiced cautious optimism about the results, while suggesting more research would be helpful before giving the green light for the medicine’s widespread use against COVID.“This is really the first large trial that shows a benefit for fluvoxamine — or any oral medication,” said Dr. David Boulware, an infectious disease specialist at the University of Minnesota and national co-chair of the NIH’s own trial investigating potential COVID treatments. “It’s inexpensive, it’s generic and it’s going to be used. So in that sense it’s a world-wide drug.” Boulware, who was co-author of one of the earlier, small studies of fluvoxamine and COVID, said some of the monocolonal antibody treatments given emergency approval by regulators have greater effectiveness, but their high cost and mode of administration limit how widely they are used. Dr. Gerald Evans, head of the infectious disease department at Queen’s University’s medical school, said he’d like to see even larger trials conducted in other parts of the world to confirm the findings. But Evans noted the trial did back up those earlier studies and was headed by respected researchers. He called the findings “impressive.” “Everything that I’ve seen does suggest it’s an honest, true signal,” he said. “This is the first drug that has shown a consistent benefit for COVID 19, which separates it from others being studied.” Fluvoxamine is part of the widely used selective serotonin-reuptake inhibitor (SSRI) family of anti-depressants, but was found previously to also have anti-inflammatory properties. COVID-19 patients get most severely ill when their immune systems go haywire in response to the infection, causing what’s called a cytokine storm. Fluvoxamine does not attack the SARS-CoV-2 virus itself, but addresses that immune response. The idea of using it was first tested by Drs. Eric Lenze and Angela Reiersen at Washington University in St. Louis. They published a paper last November involving a total of about 150 subjects randomly assigned to either fluvoxamine or a placebo, suggesting the drug curbed the rate of patients suffering serious clinical deterioration. An observational “cohort” study published in February, where patients themselves chose whether to take fluvoxamine, found that those who did were much less likely be hospitalized or have symptoms after 14 days. The Together trial, being carried out in Brazil’s Minas Gerais region, is an adaptive platform trial, where different drugs are added or removed depending on ongoing results. Fluvoxamine was added to the trial just this January in light of the results of the smaller studies, said Mills.
ERUSALEM, Aug 20 (Reuters) – In Israel’s COVID-19 wards, doctors are learning which vaccinated patients are most vulnerable to severe illness, amid growing concerns about instances in which the shots provide less protection against the worst forms of the disease. Around half of the country’s 600 patients presently hospitalized with severe illness have received two doses of the Pfizer Inc (PFE.N) shot, a rare occurrence out of 5.4 million fully vaccinated people. The majority of these patients received two vaccine doses at least five months ago, are over the age of 60 and also have chronic illnesses known to exacerbate a coronavirus infection. They range from diabetes to heart disease and lung ailments, as well as cancers and inflammatory diseases that are treated with immune-system suppressing drugs, according to Reuters interviews with 11 doctors, health specialists and officials. Such “breakthrough” cases have become central to a global debate over whether highly vaccinated countries should give booster doses of COVID-19 vaccines, and to which people. Israel began offering booster doses to people age 60 and up in July, and has since expanded that eligibility. The United States, citing data out of Israel and other findings, said on Wednesday it would make booster doses available to all Americans beginning in September. Other countries, including France and Germany, have so far limited their booster plans to the elderly and people with weak immune systems. “The vaccinated patients are older, unhealthy, often they were bedridden before infection, immobile and already requiring nursing care,” said Noa Eliakim-Raz, head of the coronavirus ward at Rabin Medical Centre in Petach Tikva. In contrast, “the unvaccinated COVID patients we see are young, healthy, working people and their condition deteriorates rapidly,” she said. “Suddenly they’re being put on oxygen or on a respirator.” Israel’s Health Ministry raised new alarm this week with a report showing the effectiveness against severe disease of the Pfizer vaccine, developed with Germany’s BioNTech, appeared to have dropped from more than 90% to 55% in people age 65 and up who received their second jab in January. Disease experts say it is not clear how representative the figures are, but agree it is concerning given evidence that overall vaccine protection against infection is waning. They cannot say whether that is due to the amount of time that has passed since inoculation, the ability of the highly contagious Delta variant to evade protection, the age and underlying health of the people vaccinated, or a combination of all of these factors. Health officials in the UK and United States, two other nations with high vaccination rates and a spike in Delta infections, have reported similar trends. In the UK, about 35% of the people hospitalized with a Delta case in recent weeks had received two doses of a COVID-19 vaccine. Nearly three-quarters of U.S. breakthrough infections that led to hospitalization or death were among people age 65 or older, according to federal data. U.S. officials said their booster plan is based on concern that over time, the vaccines will provide less protection against severe disease, including among younger adults. “We are watching other countries carefully and (are) concerned that we too will see what Israel is seeing, which is worsening infections over time” among vaccinated people, U.S. Centers for Disease Control and Prevention Director Rochelle Walensky said at a press conference on Wednesday. The World Health Organization has repeatedly urged wealthy nations to refrain from providing boosters while much of the world has yet to access their first COVID vaccine doses. The Delta variant, first identified in India, has become the dominant version of the SARS-CoV-2 virus globally, accelerating a pandemic that has killed more than 4.4 million people. In Israel, daily new cases have increased from the single digits in June to around 8,000 since the arrival of Delta. Approximately half of the cases – the majority of them mild to moderate – are in vaccinated people. Those vaccinated first in Israel were at high-risk, including people age 60 and up. The immune response of some may have weakened by the time Delta hit Israel. But for others with underlying health conditions, the vaccine may have not kicked in at all. “For some of them the vaccine did not trigger an immune response, they had no antibodies, because of the illness itself or because they are treated with medication that suppresses the immune system,” said Dror Mevorach, who heads the coronavirus ward at Hadassah hospital in Jerusalem. He cited examples such as chronic lymphocytic leukemia and lymphoma. Among 3 million vaccinated Israelis covered by Clalit, the country’s largest healthcare provider, 600 have suffered severe breakthrough cases since June. Around 75% of them were above the age of 70 and were at least 5 months after their second dose, according to Ran Balicer, Clalit’s chief innovation officer. Nearly all of them have chronic illnesses. “We are hardly seeing young vaccinated people in severe condition,” said Balicer. In the UK, doctors described similar characteristics among vaccinated patients who fall severely ill. “In those people who come in, because of their age, because of their co-morbidities, they might be people that you would expect that the vaccine is not quite so efficacious as other age groups,” said Tom Wingfield, a clinical lecturer at the Liverpool School of Tropical Medicine. A new surge in U.S. coronavirus cases and deaths has been fueled by Delta, particularly in states where vaccination rates remain low. Among vaccinated patients who become infected, there is evidence of older people being hit harder.
In Texas, 92% of the vaccine breakthrough cases that resulted in death were in people over the age of 60 and 75% had a known underlying condition that put them at high risk from COVID-19, according to a public health department spokesperson.
Initial data in Israel suggests the booster shots administered in the last few weeks are reducing the risk of infection in older peoplecompared with those who have received only two doses.
Even without boosters, Israeli doctors say that vaccinated patients tend to recover more quickly. “The vaccinated patients I’ve treated usually left the ICU in about three days. The unvaccinated patients took a week or two until they stabilized,” said Yael Haviv-Yadid, head of the critical care ward at Sheba Medical Centre near Tel Aviv. Even if the vaccine did not stop them getting ill, it may have mitigated their illness, said Alex Rozov, head of the coronavirus ward at Barzilai Medical Centre in Ashkelon. “Our cautious impression is that the vaccinated patients suffer an easier course of illness – the treatment is more effective among those who have antibodies.”
TOKYO, Aug 20 (Reuters) – Japan plans to dramatically ramp up daily COVID-19 tests,borrowing from anti-contagion measures used in the recent Tokyo Olympics, as it battles its worst wave of infections, driven by the Delta variant. New infections exceeded 25,000 on Thursday for the first time, a tally by national broadcaster NHK showed, with the surge mainly among those in their 40s and 50s, most of whom are unvaccinated..
The speed and severity of Japan’s Delta-driven infections are overtaking the strategy of targeted cluster tracing it has favoured over the mass testing used by many nations.
The cabinet office said Japan intends to employ its full daily capacity of about 320,000 polymerase-chain reaction (PCR) tests, or about triple the use now. “At least in a big city like Tokyo, the cluster methodology won’t work anymore,” said Kazuaki Shindai, a doctor and public health researcher at Kyoto University.
“If individuals can get more PCR testing, it may be helpful to find out their condition and isolate themselves and then prevent them going about.”
The government wants to use the full capacity of public and private testing “as much as possible,” said Makoto Shimoaraiso, a cabinet official guiding the pandemic response. Free PCR screenings are being offered to passengers on some airline flights, and local governments plan to use high-speed antigen tests in shopping areas, he added. Although Japan widened a state of emergency this week over Tokyo and much of the country, the effect on public behaviour is diminishing in its fourth emergency of the pandemic. Top national health adviser Shigeru Omi urged the government to step up testing and add hospital beds, suggesting that the law may have to be amended for tougher lockdowns. Japan’s COVID-19 testing, or the lack of it, has been a controversial topic throughout the pandemic, standing at just 150 tests per 1,000 people now, versus 230 in South Korea and 1,520 in the United States, website Our World in Data shows. But massive, regular testing, with close to 600,000 tests, was a key feature of infection control at the recently completed Tokyo Olympics It was a “double standard” that mass testing figured at the Games but not more widely for Japan, said Kenji Shibuya, the former director of the Institute for Population Health at King’s College London. It is never too late to increase testing in the virus battle, however, he said, adding, “This should also be combined with the efforts to isolate and monitor the infected people.”
Sens. Roger Wicker and Angus King, who are both vaccinated for the coronavirus, tested positive for Covid-19 on Thursday after experiencing symptoms. Wicker, a Republican from Mississippi, and King, an independent from Maine, are the latest in a string of prominent politicians to announce positive coronavirus tests in recent weeks despite being fully vaccinated. Others include Republicans Sen. Lindsey Graham of South Carolina and Gov. Greg Abbott of Texas. “Senator Wicker is fully vaccinated against COVID-19, is in good health, and is being treated by his Tupelo-based physician,” Phillip Waller, Wicker’s communications director, said in a statement. The 70-year-old Wicker “is isolating, and everyone with whom Senator Wicker has come in close contact recently has been notified.” The Senate is in recess this week, and many of the chamber’s members are in home states either preparing for 2022 elections or checking in with district offices. “Despite all my efforts, when I began feeling mildly feverish yesterday, I took a test this morning at my doctor’s suggestion, and it came back positive,” King, 77, said in a statement. “While I am not feeling great, I’m definitely feeling much better than I would have without the vaccine.” Sen. Angus King (I-Maine) holds a chart as bipartisan members of the Senate and House gather to announce a framework for fresh coronavirus relief legislation at a news conference on Capitol Hill on Dec. 1, 2020. Wicker’s and King’s positive tests came as the Biden administration ramps up efforts to encourage Americans to seek booster shots starting next month amid a growing pool of data that shows vaccine protections fade over time. Three of Washington’s top health experts on Wednesday provided further details on how the immune system’s protections wane over time.
It’s now “very clear” that immunity starts to fall after the initial two doses, and with the dominance of the delta variant, “we are starting to see evidence of reduced protection against mild and moderate disease,” according to a statement signed by CDC Director Dr. Rochelle Walensky, acting FDA Commissioner Dr. Janet Woodcock, White House chief medical advisor Dr. Anthony Fauci and other U.S. health leaders.
New Covid-19 cases are emerging at their highest rates since winter as the delta variant of the coronavirus sweeps across the U.S. Health experts blame its rapid spread for the uptick in case counts and deaths as a growing number of so-called “breakthrough” cases show fully vaccinated people are still at risk. More than 140,000 new cases and 822 deaths were reported in the U.S. on Monday, according to the Centers for Disease Control and Prevention. The number of new daily deaths has more than doubled since the start of August. The situation in Florida and Texas is especially grim, with case counts in both states blowing past records and overwhelming hospital systems.
The US government said on Wednesday it plans to make Covid-19 vaccine booster shots widely available to all Americans starting on 20 September as infections rise from the Delta variant of the coronavirus. The White House is prepared to offer a third booster shot starting on that date to all Americans who completed their initial inoculation at least eight months ago, the US Department of Health and Human Services said in a statement. The White House pandemic response coordinator, Jeff Zients, said the coronavirus vaccine booster shots will be free for all Americans. “It will be just as easy and convenient to get a booster shot as it is to get a first shot today,” Zients said. The booster shots initially will be given primarily to healthcare workers, nursing home residents and older people, all of whom were among the first groups to be vaccinated in late 2020 and early 2021, the department said. Top US health officials said in a joint statement that they based their decision to offer boosters on data showing that the protectiveness of Covid-19 shots currently authorized in the United States begins to diminish in the months after the shots are given. The officials included Joe Biden’s chief medical adviser, Anthony Fauci, as well as the heads of the Centers for Disease Control and Prevention, the Food and Drug Administration and the National Institutes of Health. “The available data make very clear that protection against SARS-CoV-2 infection begins to decrease over time … and in association with the dominance of the Delta variant, we are starting to see evidence of reduced protection against mild and moderate disease,” the officials said. “We conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability,” they added. The officials said that they expect that people who received Johnson & Johnson’s single-dose Covid-19 vaccine will also need boosters. US health officials previously authorized a third dose of vaccines from Pfizer Inc and Moderna Inc for people with weak immune systems. The broader booster program follows mounting evidence that protection from the vaccines wanes after six or more months, particularly in older people with underlying health conditions. Vaccinations have been widely available in the United States, unlike many other countries, and yet the Delta variant has caused what health experts describe as a pandemic of the unvaccinated as a significant number of people choose not to get inoculated. Even with the announcement on boosters, Zients said the Biden administration remained committed to convincing more Americans to get their first vaccine dose. “This remains a pandemic of the unvaccinated,” Zients said in a briefing on Wednesday morning. The new Covid-19 cases also include a number of people who have been vaccinated, though they are far less likely to experience severe disease or death than the unvaccinated. In recent weeks, several other countries have also decided to offer booster shots to older adults as well as people with weak immune systems, including Israel, France and Germany. The decision announced by the US officials represented a shift from the optimism of health authorities in May in curbing the pandemic when Biden set a goal to vaccinate 70% of American adults with at least one dose by 4 July. That goal was achieved about a month late. Daily cases in the United States soared from fewer than 10,000 in early July to more than 150,000 in August as the far more infectious Delta variant took hold. More than 1 million Americans had independently sought an extra vaccine dose before the official decision on boosters was announced, according to federal data. “This remains a pandemic of the unvaccinated,” Zients said in a briefing on Wednesday morning. The new Covid-19 cases also include a number of people who have been vaccinated, though they are far less likely to experience severe disease or death than the unvaccinated. In recent weeks, several other countries have also decided to offer booster shots to older adults as well as people with weak immune systems, including Israel, France and Germany. The decision announced by the US officials represented a shift from the optimism of health authorities in May in curbing the pandemic when Biden set a goal to vaccinate 70% of American adults with at least one dose by 4 July. That goal was achieved about a month late. Daily cases in the United States soared from fewer than 10,000 in early July to more than 150,000 in August as the far more infectious Delta variant took hold. More than 1 million Americans had independently sought an extra vaccine dose before the official decision on boosters was announced, according to federal data.
TEL AVIV, Aug 18 (Reuters) – A third dose of Pfizer (PFE.N)/BioNTech’s (22UAy.DE) COVID-19 vaccine was found to be 86% effective in people aged over 60, an Israeli healthcare provider said on Wednesday, citing initial results from a study of thousands of members. Israeli HMO Maccabi, which covers around a quarter of the country’s 9.3 million population, compared results from 149,144 people aged over 60 who received their third dose at least a week ago against those from 675,630 more who had received only two doses, between January and February.
Some 37 people tested positive for coronavirus after their third jab, compared with 1,064 positive cases among those who had received only two doses, Maccabi said in a statement. The comparison groups had similar demographic profiles, it added.
Maccabi did not provide any information on the severity of the 37 positive cases, or whether they had any underlying conditions. The Health Maintenance Organisation (HMO) did not immediately respond to a request for comment. Pfizer has said that its vaccine’s efficacy drops over time, and that a third dose showed significantly higher neutralising antibodies against the initial SARS-CoV-2 virus as well as against the Beta and highly infectious Delta variants. Israel began administering third Pfizer doses last month to confront a surge in local infections driven by the Delta variant. Some 1.1 million eligible Israelis – people over 50, healthcare workers, and others – have received their third dose. The United States and several European countries are expected to begin offering boosters to the elderly and people with weak immune systems, and some are considering whether to make a third dose available more widely. Nonetheless, Israeli health officials worry that cases will continue to mount given that another 1.1 million Israelis – around 11% of the population – remain unvaccinated. Severe cases have also continued to climb, mostly among the unvaccinated. Health ministry data released on Wednesday, based on data per 100,000 people, showed 172 serious cases among unvaccinated people over 60, compared with 21 serious cases among vaccinated individuals in the same age group. Dr. Anat Ekka Zohar of Maccabi said that the third dose “has again proved its effectiveness,” and had “demonstrated protection (against) the Delta variant”. “The triple dose is the solution to curbing the current infection outbreak,” she said.
(Reuters) -The United States reported more than 1,000 COVID-19 deaths on Tuesday, equating to around 42 fatalities an hour, according to a Reuters tally, as the Delta variant continues to ravage parts of the country with low vaccination rates. Coronavirus-related deaths have spiked in the United States over the past month and are averaging 769 per day, the highest since mid-April, according to the Reuters tally President Joe Biden’s administration confirmed on Tuesday evening it planned to extend requirements for travelers to wear masks on airplanes, trains and buses and at airports and train stations until mid-January. Like many other countries, the Delta variant has presented a major challenge. The Reuters tally from state data on Tuesday showed 1,017 deaths, taking the death toll from the pandemic to just under 623,000 people, the highest number of deaths officially reported by any country in the world. The last time the United States recorded more than 1,000 deaths on a daily basis was in March. U.S. officials have started to accelerate vaccinations in the face of the renewed threat, with the seven-day average of doses given increasing by 14% in the past two weeks, according to figures from Our World in Data While governments and businesses initially offered incentives such as cash and prizes for getting vaccinated, the surge in cases has caused some companies and states to mandate vaccines if workers want to keep their jobs and not face routine testing. However, U.S. hospitals continue to flood with new patients as COVID-related hospitalizations have increased by about 70% in the past two weeks. The United States has reported more than 100,000 new cases a day on average for the past twelve days, a six-month high, according to a Reuters tally.
The U.S. South remains the epicenter of the latest outbreak, with Florida reporting a record of nearly 26,000 new cases last week, according to data from the Centers for Disease Control and Prevention. Among the new cases was Texas Governor Greg Abbott, whose state is engulfed in a fourth COVID surge. Abbott tested positive for COVID-19 on Tuesday but so far has no symptoms of the illness, his office said. The number of children hospitalized with COVID-19 is rising across the country and were 1,834 as of Tuesday morning, according to data from the U.S. Department of Health and Human Services, a trend health experts attribute to the Delta variant being more likely to infect children than the original Alpha strain.
Top Biden administration health officials concluded that most Americans will soon need coronavirus booster shots after reviewing a raft of new data from the Centers for Disease Control that showed a worrying drop in vaccine efficacy over time, four administration officials told POLITICO.
The evidence, compiled by federal scientists over the past several months, showed a decline in the initial round of protection against Covid-19 infection that’s coincided with a resurgence in cases driven by the more contagious Delta variant.
The data looked at vaccine effectiveness in individuals across age groups, with varying medical conditions and who received the shot at different times. It was presented to White House Covid-19 task force officials at a meeting Sunday. “This is what moved the needle,” one senior administration official said, describing the CDC data and the decision to urge boosters.
That data — which is set to be made public later this week — brought a swift end to a debate over when to administer boosters that has raged within the administration for months, and spurred the buildout of a plan for distributing the additional shots in a matter of weeks.
The Biden administration is now expected to formally announce its strategy within days, following a series of meetings throughout the weekend focused on concerns that Americans’ immunity against Covid-19 was not only fading, but dropping faster than anticipated in the face of the Delta variant. Officials are still finalizing the details of the booster plan, and the government is not expected to begin offering third shots from Pfizer and Moderna until mid-September at the earliest. The Food and Drug Administration must first authorize the booster shots, and the CDC will need to formally recommend that people get them eight months after completing their initial vaccination round. But the move represents an acceleration of a process that had proceeded cautiously, as officials hunted for clear signs that the vaccines’ immunity was waning. The plan for now doesn’t call for boosters for recipients of the single-dose Johnson & Johnson vaccine. Federal officials are awaiting results of a study by the drugmaker on the effectiveness of administering two J&J doses. The White House and the Department of Health and Human Services did not respond to requests for comment. Inside the administration, some health officials had long argued that boosters would be needed as soon as fall, and should be given pre-emptively to ensure that people’s protection against Covid-19 remained high. Others, including officials at the CDC, were more skeptical, contending the data did not yet show a need for boosters — and questioning whether the administration should wait until it became clear that protection from severe infections that could cause hospitalization or death was wearing off.
Yet top health officials coalesced around the more immediate need amid growing indications that the Delta variant could significantly set back the nation’s progress against the pandemic.
Data from Israel had found that the Pfizer vaccine’s ability to prevent severe disease and among older people first vaccinated in January had declined over time. And a study released last week by the Mayo Clinic found the effectiveness of the Pfizer vaccine against mild infections had fallen — though it was still performing well in preventing hospitalization. Against that backdrop, it was the CDC’s own similar findings that proved the deciding factor. The agency’s study gave officials a high-resolution view of the extent to which protection was declining for different groups. The administration’s emerging booster plan will rely on roughly 100 million doses of Pfizer and Moderna’s vaccines that are available immediately, according to two senior officials with knowledge of the situation. The government has contracted for an additional 400 million shots to be distributed as needed following the announcement, they added. Administration officials downplayed the decision to exclude for now of J&J vaccine recipients, noting that vaccine was not authorized until late February and that recipients would not be eligible for a booster until October. Still, the decision to forge ahead with third shots of Pfizer and Moderna is likely to invite backlash both at home and abroad. The World Health Organization has urged developed countries to hold off on booster shots over fears that a new round of mass vaccinations will make it even more difficult for lower-income countries to get access to initial supplies of the vaccines. “Administration of booster doses will exacerbate inequities by driving up demand and consuming scarce supply while priority populations in some countries, or subnational settings, have not yet received a primary vaccination series,” the WHO said in an Aug. 10 statement. Biden officials are confident they can fulfill their vows to be an “arsenal of vaccines” for the world while sending Americans back for more because of their surplus of shots and expectation that many more are on the way, an administration official said. It would also be virtually impossible to stop people from seeking boosters if drug makers apply for approval and they’re deemed effective — an FDA determination that cannot take into account factors such as worldwide need. Health officials have closely watched the nation’s case numbers for signs that the increase might peter out, similar to the sudden drop-off in infections seen in the U.K. But that hope has dimmed with each passing day, especially amid a spate of reports of outbreaks among children and teachers as schools reopen in some states. Now, with nearly 30 percent of the country still unvaccinated and growing evidence of Covid-19’s transmissibility, administration officials are opting to take action however they can to try to blunt what many fear will be a brutal autumn. “It’s a combination of Delta being a particularly nasty variant that’s very contagious and the fact that, unsurprisingly, vaccine protection does gradually wane over time,” National Institute of Health Director Francis Collins said Tuesday on the Hugh Hewitt Show. “We don’t want to wait until it’s like, oh, too late.”
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