Pfizer jab gets FDA’s full approval

The Food and Drug Administration on Monday announced that it had approved Pfizer and BioNTech’s Covid-19 vaccine, opening the door to more widespread vaccine mandates as schools and universities begin their academic years. The approval comes eight months after the FDA issued Pfizer its first emergency-use authorization for a Covid-19 vaccine on Dec. 11. Since then, more than 204 million doses of the vaccine have been administered in the U.S. alone. On Monday, the FDA’s acting commissioner, Dr. Janet Woodcock, said the approval should boost public confidence in the Pfizer vaccine.

“As the first FDA-approved Covid-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” Woodcock said in a statement.

The agency approved the vaccine in people aged 16 and older. Emergency-use authorization remains in place for those aged 12 to 15. A third dose for immunocompromised individuals is also still authorized, but not yet approved. “I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity,” Pfizer’s CEO, Albert Bourla, said in a statement after the approval was announced. Pfizer shares were up 3.9% Monday morning, while BioNTech’s American depositary receipt was up 9.9%. Moderna (MRNA) shares also climbed 5.5%. Emergency-use authorization is short of the full approval that most vaccines and therapeutics must receive before they can be administered to patients. The FDA and Pfizer have been working toward full approval for months. Neither of the other two Covid-19 vaccines to be authorized in the U.S., from Moderna and Johnson & Johnson (JNJ), has received full approval. Approval of the Pfizer vaccine won’t change much for the hundred million people in the U.S. who have already received it. It could, however, ease the way for businesses and institutions seeking to require vaccination as a condition of returning to in-person work or school.  Speaking on CNN’s State of the Union on Sunday, Surgeon General Dr. Vivek Murthy said full approval could allow for more vaccine mandates. “For businesses and universities that have been thinking about putting vaccine requirements in place in order to create safer spaces for people to work and learn, I think that this move from the FDA, when it comes, will actually help them to move forward with those kinds of plans,” Murthy said. While some vaccine mandates have already been put in place, others have waited on full FDA approval. The Department of Defense, the world’s largest employer, has said it plans to require Covid-19 vaccines for members of the military once the FDA approval is in place. Though there have been legal challenges to vaccine mandates, they have been met with little success in the courts. The Supreme Court in mid-August declined to intercede in a challenge brought by students at Indiana University. The long-term outlook for the pandemic is making a long-lasting and robust market for Covid-19 vaccine boosters look increasingly likely, a bullish sign for the current leading Covid-19 vaccine makers.

Booster COVID-19 shots should be delayed -Says WHO director-general US CDC says get the booster shot!

BUDAPEST (Reuters) – WHO Director-General Tedros Adhanom Ghebreyesus said on Monday that COVID-19 booster shots should be delayed as priority should be given to raising vaccination rates in countries where only 1% or 2% of the population has been inoculated. If vaccination rates are not raised globally, stronger variants of the coronavirus could develop and vaccines intended as booster shots should be donated to countries where people have not received their first or second doses, he said during avisit to Budapest. “In addition, there is a debate about whether booster shots are effective at all,” Ghebreyesus told a news conference with Hungarian Foreign Minister Peter Szijjarto. Those whose immune system is compromised should get a booster shot, though they represent only small percentage of the population, he added. The WHO said last week current data does not indicate that COVID-19 booster shots are needed and that the most vulnerable people worldwide should be fully vaccinated before high-income countries deploy a top-up. The Unites States announced last week it plans to make COVID-19 vaccine booster shots widely available starting on Sept. 20 as infections rise from the coronavirus Delta variant.  Hungary has already started widely distributing booster shots. Nick Note: This WHO prick is a menace to mankind. You might recalled he delayed in declaring the China Plague allowing a lost opportunity to control it early on. The fact is after 6 months your vaccine is 80% gone. Tell him to go fuck himself and get your life saving 3rd booster shot and your fourth when it becomes available.

UK orders 35 million more Pfizer/BioNTech COVID vaccines

LONDON (Reuters) – Britain has agreed to buy 35 million more doses of the Pfizer/BioNTech COVID-19 vaccine, to be delivered from the second half of next year, as part of its preparations for booster shots and any new variants that could emerge. “While we continue to build this wall of defence from COVID-19, it’s also vital we do everything we can to protect the country for the future too – whether that’s from the virus as we know it or new variants,” health minister Sajid Javid said. Nick Note: I finally joined something.. The Illuminati did not want me. Even though my grand father was a high degree Maison and i learned the secret hand shake no one asked my to join. So now i am joining the 1 billion people injected with mind controlling nanbots……. And its was easy a few jabs in my arm… Nothing to study, no tests to take……. And i just found out Jessie Jackson also had his nanrobot jab to. I wish him a speedy recovery… I guess he should have gotten the second jab…..

 

Israel finds COVID-19 vaccine booster significantly lowers infection risk

JERUSALEM, Aug 22 (Reuters) – A third dose of Pfizer (PFE.N)‘s COVID-19 vaccine has significantly improved protection from infection and serious illness among people aged 60 and older in Israel compared with those who received two shots, findings published by the Health Ministry showed on Sunday. The data were presented at a meeting of a ministry panel of vaccination experts on Thursday and uploaded to its website on Sunday, though the full details of the study were not released. The findings were on par with separate statistics reported last week by Israel’s Maccabi healthcare provider, one of several organisations administering booster shots to try to curb the Delta coronavirus variant. Breaking down statistics from Israel’s Gertner Institute and KI Institute, ministry officials said that among people aged 60 and over, the protection against infection provided from 10 days after a third dose was four times higher than after two doses.

A third jab for over 60-year-olds offered five to six times greater protection after 10 days with regard to serious illness and hospitalisation.

That age group is particularly vulnerable to COVID-19 and in Israel was the first to be inoculated when the vaccine drive began in late December. In recent weeks, the health ministry has said immunity has diminished over time for seniors and younger people as well. Most vaccinated people who fell severely ill in Israel were over 60 and with underlying health conditions. Israel started administering third jabs to over 60-year-olds on July 30. On Thursday it dropped the age of eligibility for a booster to 40, and included pregnant women, teachers and health care workers below that age. Third doses are given only to those who received their second shot at least five months ago.

The United States has announced plans to offer booster shots to all Americans, citing data showing diminishing protection. Canada, France and Germany have announced booster campaigns.

Fighting an outbreak of the Delta variant since June, Israel presently has one of the world’s highest infection rates per capita. Close to 1.5 million people out of the country’s 9.3 million population have taken a third jab. Nick Note: I had my 3rd booster shot two weeks ago. I am breathing easier.. get my Pun? I urge you to get your third vaccine you can play with the system. Its best not to delay. I am seeing a significant rise in people with the two vaccines testing positive, requiring hospitalization and the death rate is higher then before…. This is real world….. And yes i feel a certain release as the nanobots take control of my brain… Especially when the magnetism increases as i get near to 5G cell phone towers. I fell this urge to climb the towers closer to the antenna. that way i can be nearer to my  nanbit zombie master,,,,,,,  Yes Master,,,,…. i am here to bend my will to your will…….And be your cyber bitch…… Finally a cult i can embrace,(Crea Yoga did not work)  Its the nanobit defense… Its not my fault the nanobite made me do it!

Beating Back Delta Will Take Extra Covid Shot for Privileged Few

The roll out of a third dose of Covid vaccine has sparked debate on ethical and political grounds, since a large swath of the human population is yet to receive any inoculation. But the case for boosters on scientific grounds is building. The reason is delta. The most-infectious coronavirus variant to emerge so far is in a race with the human immune system, and there’s mounting evidence that delta is winning — at least initially. Fully vaccinated individuals infected with the variant have peak virus levels in the upper airways as high as those lacking immunity, a large study from the U.K. showed last week. That suggests people with delta-induced breakthrough infections also may be capable of transmitting the virus, frustrating efforts to curb the Covid pandemic. Waning antibody levels in some highly vaccinated populations such as Israel have prompted calls to offer boosters to blunt fresh waves of hospitalizations.  “The science is the boosters work, and they will definitely help,” said Shane Crotty, a virologist and professor at the La Jolla Institute for Immunology’s Center for Infectious Disease and Vaccine Research in California. In fully vaccinated, healthy adults, booster shots from Moderna Inc. as well as Pfizer Inc. and its partner BioNTech SE cause antibodies to rebound to peak levels, if not well beyond, Crotty said in a Zoom interview Friday. Those antibodies are also likely to be more durable and adept at fighting a wider range of SARS-CoV-2 strains, he said. That’s especially helpful in fighting delta. Researchers in China found the strain is detectable in patients four days after picking up the virus — two days earlier than was previously observed — indicating the strain makes individuals infectious sooner.  People infected with delta were also found to have significantly higher amounts of virus in their upper airways compared with infections caused by other strains. “It’s inherently tougher to stop with antibodies because there’s more of it and it’s a tougher challenge for the immune system,” Crotty said. Bolstering antibody levels with an extra dose of vaccine may enable the immune system to swiftly block delta on its arrival in the nose and throat, preventing the coronavirus from not only infecting cells and causing illness,  but also stopping it from spreading, he said. A slower antibody response, on the other hand, may increase infectiousness and worsen symptoms. “It’s a race between the virus and your immune system,” Crotty said. The faster the virus replicates, the less time antibodies have to block an infection. Still, even when a delayed antibody response does lead to infection, immunity generated by either vaccination or a natural infection is usually enough to prevent it causing severe illness in an otherwise healthy person, he said. Most pediatric vaccine regimens are administered over three shots, Crotty said. “A lot of that is about the mechanics of immune memory generation — that it’s frequently taken three exposures to get that,” he said. Three studies published by the U.S. Centers for Disease Control and Prevention last week showed that although delta may be hastening a decline in the effectiveness of the Moderna and Pfizer-BioNTech shots at preventing SARS-CoV-2 infections, including among nursing home residents, the vaccines remained a reliable shield against hospitalization over a six-month period. Delta can cause breakthrough infections and illness in people with lower antibody levels, said Andrew Pekosz, a professor of molecular microbiology at the Johns Hopkins University Bloomberg School of Public Health in Baltimore. “The good news is that vaccine efficacy against severe disease is still maintained,” he said. In addition, fully immunized people infected with delta may be infectious for a shorter period compared with individuals lacking immunity, reducing their propensity to transmit the virus, Pekosz said. It’s possible the infectiousness of vaccinated individuals could be further reduced with third shots using a different inoculation, delivery via a nasal spray, or using smaller amounts of the same vaccine, he said.  “We are still working out the mechanics of how best to use these vaccines for maximum protection,” said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota in Minneapolis. “Our challenge is going to be how to continue to use these vaccines to maximize the most important aspect of public health: preventing infections.” Curbing spread is also key to preventing the emergence of variants even more dangerous than delta, he said. That goal must be sought globally with equity and solidarity, Osterholm said. “It’s a worldwide epidemic that will continue until you take care of it around the world,” he said. “From a humanitarian standpoint, this is obviously critical.” In the U.S., unvaccinated people are now swamping medical institutions in large swaths of the country, Johns Hopkins’ Pekosz said. “Vaccination would keep people out of the hospital, and that is the most important thing that vaccinations can do.” La Jolla’s Crotty estimates that more than 90% of SARS-CoV-2 transmission is from unvaccinated people. “In the U.S., we’ve got so many of those,” he said. “If you have two doses of vaccine, it’s way more valuable for those two doses to go to an unvaccinated person than people getting boosters if you want to talk about transmission,” Crotty said. “But if you can’t convince the people to get the damn things and somebody else wants them now, will it actually help the other person? Yeah, it will help them.”  Nick Note: Tell you what…BE a member of privileged society and get your 3rd booster shot. I have lived all over the world and we have always been privileged people.. better educated, freer, smarter and wealthier. Stop apologizing for GODS gifts and enjoy and appreciate them. One other thing. Americas are among the most hard working people in the world….. My opinion about third world shit holes is its hopeless… Poor people have poor ways…….. The poor will always be among you.

U.S. administers 360.6 million doses of COVID-19 vaccines – CDC

Aug 20 (Reuters) – The United States has administered 360,634,287 doses of COVID-19 vaccines in the country as of Friday morning and distributed 426,106,115 doses, the U.S. Centers for Disease Control and Prevention said. Those figures are up from the 359,623,380 vaccine doses the CDC said had gone into arms by Aug. 19 out of 422,175,735 doses delivered.

The agency said 200,421,787 people had received at least one dose while 169,998,983 people are fully vaccinated as of Friday.

The CDC tally includes two-dose vaccines from Moderna (MRNA.O) and Pfizer/BioNTech (PFE.N), , as well as Johnson & Johnson’s (JNJ.N) one-shot vaccine as of 6:00 a.m. ET on Friday. Nick Note: that means 170 million people need their 3rd dose and 200 million need their 2nd and 3rd dose. Lets suppose we lump them all together for 1 dose starting in September… You need to inoculate 370 million people…..And that is just to get marginal immunity to half the eligible people…….Herd immunity is an impossibility…. in fact you are not going to stop the delta spread never mind the two other variants that are coming..  Not enough vaccines soon enough to enough people to stop the slaughter, New Vaccination booster shots are not going to happen in time….. We get the vaccines tailored to the 3 circulating vaccines in February…… That means in 6 months you need to vaccinate 370 million people all over again….. Add the anti vaccers that are getting scared shit as their good old boy buddies go on ventilators and don’t come back to the country music bar.  You need to do 1 billion vaccines by next spring to save the majority of the population. Not going to happen. Save yourself and your loved ones. And rush to get your3rd booster shot in a few weeks.  In another 6 months get in February your 4th shot. And be prepared to get vaccinated every 6 months that the scientists always new would have to happen. As for the stupid money all i can say is fire up the cremation machines…..

Rain puts a halt to New York comeback concert in Central Park

NEW YORK — Rain and thunder brought a halt to the city’s comeback concert at Central Park on Saturday night. Music luminaries and thousands of New Yorkers had been partying like it was 2019, hitting a hopeful note late in the second summer of COVID-19, before rain and thunder came in the middle of Barry Manilow’s set. Organizers were hoping for better weather to resume the show, but it’s unclear if it the show will go on. Bruce Springsteen and Paul Simon were among those yet to take the stage before the show was halted. The show was meant to herald the return of New York City, even as Hurricane Henri set its sights on the Northeast. Throngs of vaccinated music fans — some masked, most not — filled into the 55-acre field long before the first act. Concert staff asked for proof of shots at the gates. Many concertgoers draped beach towels over the grass on a sticky, hot evening in Manhattan. They scouted out spots in the shadow of a stage and light display that screamed “NYC” in imposing lettering. Brooklyn-raised music mogul Clive Davis booked the show’s star-studded lineup, a list that also included opera tenor Andrea Bocelli, rapper LL Cool J and guitar genius Carlos Santana. Bocelli, one of the first acts, sang “You’ll Never Walk Alone,” a folk song that became a pandemic anthem, with its optimistic encouragements for the lonely. “We crossed a terrible storm this year,” Bocelli told the crowd. Not long after, Santana performed a boisterous rendition of “Maria Maria” as New Yorkers swayed.  Also on the bill were Brooklyn-born balladeer Barry Manilow, punk powerhouse Patti Smith and hip-hop star Wyclef Jean. Davis, 89, said ahead of the concert that the selections were meant to “do justice to the full range of great New York music.” The event, broadcast on CNN and branded the “Homecoming Concert,” put an exclamation point on a week of concerts across the five boroughs in celebration of New York’s comeback. The city coordinated the concert along with Davis and Live Nation, an entertainment company. Many tickets were free, though passes were tricky to acquire. Mayor Bill de Blasio, proud of the city’s rebound from a crisis that in the spring of 2020 turned its streets grim and ghostly, had crowed for weeks about the concert. And he appeared fired up when he took the stage shortly after 7 p.m. “This is the greatest concert in the history of New York!” de Blasio thundered. “Let’s thank the front-line workers of New York City who brought us back.” Many celebrities made appearances. Stephen Colbert, host of “The Late Show,” was spotted dancing on the grounds with Senate Majority Leader Chuck Schumer, who lives in Brooklyn. Meanwhile, balloons and beach balls bounced above the crowds on the Great Lawn. A palpable sense of joy overcame the ongoing threat posed by the ultra-contagious delta variant. And locals came from far and wide to soak in the celebration. Al Cartagena, 55, traveled from the Throgs Neck neighborhood in the Bronx to see the concert, which he said was a once-in-a-lifetime moment for him and his wife. They dished out about $88 apiece for their tickets, he said, and took the subway and the bus to get the park by around 2:30 p.m. With whipping winds and rain churning up the East Coast, the couple were ready for wet weather, Cartagena said about an hour before the concert began. Henri was expected to make landfall on Long Island on Sunday. “I’m glad we’re here before the storm,” he said. “We’re ready. We’ve got our ponchos.”  But despite brief moments of pre-concert drizzle, a positive sign from above arrived as the concert revved to rock at 5 p.m. The sun peeked out from behind the clouds, and washed Central Park in golden light. All looked good — for a while. Then the rains came. Nick Note: This proves the denial people are in and the lack of leadership. First of all this concert was suppose to celebrate the end of the covid plague… Just as the variants are coming and lockdowns will soon be the order of the day.  I watched the concert on CNN. I had a lot of cousins and friends who despite my warning about the coming hurricane and the fact it was a super spreader event they went any way. I watched as the clouds built and thought to myself why would you throw a outdoor concert when a hurricane is coming/// I guess NY authorities do not get weather reports. So they shut down the concert. A point in fact the night of the concert saw the most rain fall EVER in central park…… People are doomed. For the record people were suppose to be vaccinated…. even if it was only one shot. And they threw the concert with no testing,  no masks are even an attempt at social distancing…. And then the rains came to throw cold water on their ha ha ha celebration…….

Britain reports 32,058 new COVID cases, 104 deaths

LONDON, Aug 21 (Reuters) – Britain recorded 32,058 new cases of COVID-19, government data showed on Saturday, and reported a further 104 deaths within 28 days of a positive test.The data compared with 37,314 new cases reported on Friday and 114 deaths. Nick Note: we do not have enough data to understand what is really going on. It appears to me vaccines are failing after 6 months. And although its not readily admitted fully vaccinate people are not only getting infected by dying at alarming rates. Its much to early to tell what the third booster shot will do. It is obvious that we need the the fourth  booster shot with the antibodies for the  the 3 new variants.

More than one million dead in Latin America as variants spread

Experts say Latin America is fast becoming the new epicenter of the COVID-19 pandemic. More than one million people there have died. The only exception is Chile, where 80 percent of the population are fully vaccinated. Otherwise, health systems are struggling to cope. COVID-19 has claimed the lives of nearly 200,000 people in Peru, where the vaccination campaign is only slowly getting underway. Just 16 percent of the population are completely inoculated. The country is battling several coronavirus variants. Colombia is experiencing one of the longest peaks of infection since the coronavirus arrived in the country. This third spike has put the national medical system to the test. Quarantine measures have been struggling to strengthen an already strained system. ICUs in the country’s second largest city Medellín are over 95 percent occupied. Doctors insist the national model of pandemic care has failed.

Russia reports 20,564 new COVID-19 cases and 762 deaths

MOSCOW, Aug 22 (Reuters) – Russia reported 20,564 new coronavirus cases on Sunday, including 1,661 in Moscow and 1,481 in St. Petersburg, which took the national tally to 6,747,087. The Russian coronavirus task force said 762 more deaths of coronavirus patients had been confirmed in the past 24 hours, bringing the official death toll to 176,044. Rosstat, the government statistics agency, keeps a separate count from the pandemic task force and says it has recorded about 315,000 deaths related to COVID-19 between last April and June this year. Russia has reported about 463,000 excess deaths from April 2020 to June this year, according to Reuters calculations based on the latest Rosstat data. Some epidemiologists say excess deaths are the best way to measure the real death toll from COVID-19.