As expected Moderna has filed for full COVID vaccine approval. They had to wait until until a full six months follow-up data from their Phase 3 trial was available and compiled. Pfizer filed a couple weeks ago. Moderna officially seeking FDA approval for its COVID-19 vaccine https://www.cbs17.com/community/health/coronavirus/moderna-officially-seeking-fda-approval-for-its-covid-19-vaccine/amp Moderna announced Tuesday it has officially filed for full approval from the U.S. Food and Drug Administration for its two-dose COVID-19 vaccine. The vaccine is currently only authorized for emergency use in the United States. Full approval would signal the FDA’s full confidence in the vaccine and would be granted based on more data. Moderna said in a press release it will continue to submit data to the FDA on a rolling basis over the coming weeks with a request for a priority review. The development comes just weeks after Pfizer and BioNTech sought full approval for their COVID-19 vaccine in the United States. Moderna has an agreement with the government to supply 300 million doses of its COVID-19 vaccine. More than 151 million doses of Moderna’s vaccine have been distributed around the United States, with roughly 124.5 million shots administered as of Monday, according to the Centers for Disease Control and Prevention. Moderna said in April its vaccine showed strong protection against the coronavirus six months after people received their second shot, with the efficacy of more than 90% against all cases of COVID-19 and more than 95 percent against severe COVID-19. Under an emergency use authorization, the FDA makes a product available to the public during an emergency based on the best available evidence, without waiting for all the evidence needed for full approval or clearance. Full approval for the vaccines, which are at the forefront of global immunization efforts, could be an important step in allaying vaccine hesitancy, a growing concern in the United States and other wealthy nations. The FDA previously authorized changes to Moderna’s vaccine to provide extra doses from each vial. The agency said it approved new vials from Moderna that can contain up to 15 doses each, compared with the original vials designed to hold 10 doses. Additionally, regulators said providers can safely extract up to 11 doses from the original 10-dose vials. Those changes will be added to instructions for health care workers.
Israel offers a glimpse of life after herd immunity: With 80% of adults vaccinated, cases have dropped to 15 per day https://www.businessinsider.com/israel-vaccinated-most-adults-covid-herd-immunity-2021-6 Israel lifted some of its last COVID-19 restrictions on Tuesday as new cases declined to 15 per day. Some experts think Israel has reached herd immunity by vaccinating 80% of adults. But international travelers could still bring the virus in, despite Israel's tight travel restrictions. As the US scrambles to incentivize people to get vaccinated, Israel is reaping the benefits of its successful vaccine rollout: The nation reported just 15 new daily coronavirus cases, on average, in the last week — its lowest count in more than a year. The decline in infections has been so encouraging that Israel lifted some of its last remaining coronavirus restrictions on Tuesday. Businesses can now operate at full capacity, and residents no longer have to show proof that they've been vaccinated to enter restaurants, sporting events, or entertainment venues. Even before the new rule, Israel's schools were fully open, masks were no longer required outdoors, and mass gatherings were taking place across the country. Now Israel's only barrier to normal life is a requirement to wear masks in public indoor spaces — a rule that could be lifted as soon as next week, according to Israeli health officials. "This is probably the end of COVID in Israel, at least in terms of the current strains that we know," Dr. Eyal Zimlichman, deputy director general at Sheba Medical Center, Israel's largest hospital, told Insider. "We've obviously reached herd immunity." Scientists previously estimated that getting to herd immunity — the threshold beyond which the virus can't easily pass from person to person — would require countries to fully vaccinate 70% to 85% of their residents. But Israel has vaccinated just 60% of its citizens, or roughly 80% of its adult population, so far. Vaccines haven't been authorized there for children under 16 yet. That's a sign that other countries could vanquish their outbreaks with similar vaccination levels, Zimlichman said. He estimated that around 70% of Israeli citizens now have immunity to the virus, either through vaccines or natural infection. "We know now for sure that this number is enough to create herd immunity," he said. Israel's vaccine passport created an incentive Experts are hopeful that the US is following Israel's trajectory: The nation has fully vaccinated 52% of adults and 41% of total residents so far. But an April Kaiser Family Foundation poll found that 13% of Americans never plan to get vaccinated, while 15% are still waiting to decide. Another 6% said they would only get vaccinated if shots were required for work, school, or other activities. "I'm optimistic about actually getting to 60%, but the daily reported doses have been decreasing since around mid-April," Jorge Alfaro-Murillo, an associate research scientist at the Yale School of Public Health, told Insider. "The first people who get the vaccine are of course going to be the ones that were more willing to take it." The US is vaccinating less than 1.2 million people per day, on average, compared to 3.3 million at its peak in mid-April. States are now incentivizing people to get vaccinated by offering lottery tickets, vacations, or cash prizes. Israel took a different approach to vaccine incentives: Its Green Pass system allowed people to enter restaurants, sporting events, museums, gyms, and hotels only if they showed proof of vaccination or a negative COVID-19 test. "Life became much easier for you if you were vaccinated and that was another incentive for people," Zimlichman said. "They didn't want to feel like second-level citizens." None of this has been true in the Palestinian territories, however. Less than 5% of the Palestinian population has been fully vaccinated. (Palestinians in East Jerusalem have access to Israeli health insurance, but that doesn't extend to Palestinians in the West Bank and the Gaza Strip.) Several human-rights organizations have called on Israel to give Palestinians vaccines right away. "In the Palestinian communities, if they're not vaccinating as much and then there's a new strain that comes up that can evade the vaccine protection, then that's going to be a big issue," Alfaro-Murillo said. Mass gatherings in Israel put vaccines to the test Israel's vaccination campaign has effectively ended already. "We're not seeing more people get vaccinated — it's pretty rare at this point," Zimlichman said. "Those that wanted to get vaccinated had more than enough opportunities at every age level over the age of 16." Now the country's vaccination rate is being put to the test by mass gatherings. In late April, tens of thousands of Israelis gathered in Galilee for Lag B'Omer, a Jewish holiday — the largest public gathering in Israel since the start of the pandemic. A stampede at the event killed dozens and left around 150 people hospitalized. Then last month, many Israelis crowded in bomb shelters amid the violent clashes between Israel and Gaza. All the while, infections continued to drop: Israel's average weekly coronavirus cases have declined 80% in the last month. "If you came to Israel, the sense would be that this is a country that doesn't have any COVID," Eyal Leshem, an infectious-disease specialist at Sheba Medical Center, told Insider. Israel is still closed to most travelers Part of Israel's success may have to do with the nation's tight travel restrictions. It's is still closed off to most tourists, and incoming travelers are required to quarantine for two weeks, then take a COVID-19 test on their ninth day in the country. Israeli citizens must get special permission to travel to nine countries where infection rates are high or coronavirus variants are spreading widely: Argentina, Brazil, Ethiopia, India, Mexico, Russia, South Africa, Turkey, and Ukraine. The US, by contrast, just recommends that Americans avoid countries with high transmission. Residents are allowed back into the US by presenting a negative COVID-19 test. Fully vaccinated Americans don't have to quarantine after returning to the country. "We're much bigger than Israel and we also have a lot more people that are coming in and going out of the country," Alfaro-Murillo said. "I don't feel like this is going to be over until the whole world is where Israel is right now."
Eighty-percent of adults is a good vaccination rate but their immunity rate is higher because - and I don’t know why we ignore this - they are not counting people with natural immunity. We are in a much stronger immunity position than we think. I don’t know if I’ve ever seen a greater failure in information reporting universally. And there are plenty of unanswered and very important questions going forward with regard to natural immunity. Two big ones are: 1. how long does immunity last 2. What differences are there between natural antibodies and vaccinated antibodies It’s important to note that natural immunity is very strong. For example, when we seek plasma donations for antibodies we don’t want vaccinated people donating, we want people with natural immunity.
From an earlier post on April 12th - https://www.elitetrader.com/et/threads/the-biden-covid-vaccine.352858/page-31#post-5363566 Let's walk through some basic math. Even when 50% of the U.S. adult population achieves full vaccination we are still nowhere near herd immunity. 255 Million people in the U.S. population are 18 and older (2019) out of our 328 Million population. This is 77.7% of our population. If 50% of the U.S. adult population is vaccinated; this means that 38.8% of the U.S. population is vaccinated for a total of 127.5 Million people vaccinated. However we need to take in account the percentage of the adult population who have lasting natural herd immunity from catching COVID. The U.S. has experienced 32 Million COVID cases. For each proven case there appears to be 3 infections that were not caught with testing. This implies the U.S. has experienced 128 Million cases. Of these (following population distribution) 99.5 million were in adults 18 and over. Studies have shown that only 60% of people who caught COVID have antibody levels which provide immunity after 6 months. This means that 40% of people who caught COVID are not immune. This implies that only 76.8 Million of the people who caught COVID would have natural herd immunity in the U.S. However the accounting does not stop here; approximately 50% of the adults who previously got COVID have also been vaccinated. This means that (99.5 million adults * 60% effective * 50% got vaccinated) = 29.9 million adults must be subtracted from the "natural immunity" total since they actually are on the vaccinated list. This leaves 76.8 million minus 29.9 million people for a total of 46.9 million people in the U.S. have natural immunity which will last longer than 6 months. This means that 127.5 Million adults are vaccinated plus 46.9 million people with natural immunity (not on the vaccination list). This gives 174.4 Million people in the U.S. with immunity not accounting for that vaccines only have 78% to 95% efficacy. Herd immunity for COVID will require 70% of the population (229,6 Million people) to have immunity at minimum. We currently are only at 174.4 Million people (53.2%). We are making progress but there is further to go. Also there is a concern that herd immunity for a population will require closer to 85% of a population for COVID rather than 70%. Of course this calculation does not even consider that vaccines are less effective against COVID variants and that people who caught COVID are probably not immune against most variants.
https://www.sciencemag.org/news/202...s-heart-inflammation-and-covid-19-vaccination Israel reports link between rare cases of heart inflammation and COVID-19 vaccination in young men Science’s COVID-19 reporting is supported by the Heising-Simons Foundation. The COVID-19 vaccine made by Pfizer and BioNTech appears to put young men at elevated risk of developing a heart muscle inflammation called myocarditis, researchers in Israel say. In a report submitted today to the Israeli Ministry of Health, they conclude that between one in 3000 and one in 6000 men ages 16 to 24 who received the vaccine developed the rare condition. But most cases were mild and resolved within a few weeks, which is typical for myocarditis. “I can’t imagine it’s going to be anything that would cause medical people to say we shouldn’t vaccinate kids,” says Douglas Diekema, a pediatrician and bioethicist at Seattle Children’s Hospital.
Moderna plans mix of COVID-19 vaccine doses with new Lonza deal https://www.reuters.com/business/he...ne-boost-moderna-covid-19-vaccine-2021-06-02/ Moderna is gearing up to halve the dose of its COVID-19 vaccine, the U.S. drugmaker said on Wednesday, so that it can also be used to combat variants and inoculate children. It has agreed a deal with Swiss-based drugmaker Lonza (LONN.S) which said a new drug substance production line in Geleen, Netherlands, will have capacity to make ingredients for up to 300 million doses annually at 50 micrograms per dose. "We're assuming that as of 2022, we are going to have a mix of dose levels on the market," a spokeswoman for Moderna said, following the announcement of Lonza's new production. Moderna, which has been studying lower-dose versions to help stretch supplies of its vaccine, has been delivering an approved 100-microgram dose to date. The drugmaker has said early booster shot data for a 50-microgram version showed it helped protect against emerging virus variants. Lower-doses may also be given to children who may not require a full one. read more Combined with a previous deal with Spain's Rovi (ROVI.MC), Moderna's pact with Lonza brings 50-microgram production in Europe to up to 600 million doses annually, with the capacity due to come on line this year. Pfizer's (PFE.N) and BioNTech's (22UAy.DE) mRNA shot has been approved for 12-15 year olds in Europe and the United States, and Moderna is aiming for approval for teens as data showed its shot has been found safe and effective. read more Moderna aims to deliver up to 3 billion doses in 2022, up from 800 million to 1 billion doses this year, but has not specified the dosing mix. In addition to the planned Dutch production, Lonza has three production lines in Visp, Switzerland, where it is ramping up annual capacity to 300 million doses at 100 micrograms per dose. In April, it announced plans to double Visp production by next year. read more The Swiss drugmaker also produces ingredients for Moderna in the United States. Sweden's Recipharm (RCPHF.PK), Samsung Biologics (207940.KS) as well as ThermoFisher , which inked a deal with Moderna this week, also have roles in making the shot. read more
Sinopharm still running into problems and negative press out in the real world. It has been going on for quite a while. But, yes the finally got approval for emergency use and to have it included as a covax vaccine so that WHO/UN/American dollars can be used purchase it. Realistically, if China wanted WHO approval it was never in doubt. Nevertheless, real live people in real countries are asking: "Does this shiite work or no." Yeh, other than that, they are on track to be the leading supplier to the third world. OR NOT. We have seen these reports before, eh. Just sayin it does not seem to be getting better. I am pretty sure that bilions and billions of American dollars will be spent on this shiite before it is over. We have given WHO over six billion for the covax program. In otherr words, we fund, but WHO chooses the suppliers, and which country does WHO answer to? Of course a bad pandemic among a vaccinated population would be something that gets attention, if that happens, more than already, that is. China’s great vaccine hope, Sinopharm, sees reputation darkened amid covid spikes in countries using it Last year, Bahrain became one of the first countries to throw support behind China’s Sinopharm vaccine, granting it emergency use approval in December — a substantial boost for Beijing’s global ambitions for the vaccine, despite doubts on the part of some scientists over lack of public safety and efficacy data. Now, the Persian Gulf country is the latest to raise doubts about the vaccine’s effectiveness. Bahraini officials told news outlets this week that it would be offering Pfizer-BioNTech doses to certain high-risk individuals who have already received two Sinopharm jabs, suggesting they no longer saw two doses of the Sinopharm vaccine as enough, in the face of a new wave of coronavirus infections. The policy comes just weeks after the World Health Organization granted Sinopharm emergency use listing, making it the first Chinese-developed vaccine to receive the global health body’s stamp of approval. The vaccine, developed by Sinopharm with the Beijing Institute of Biological Products, makes up a significant chunk of China’s own supply of vaccines for domestic use. Though slow to start, China’s vaccination drive is ramping up, with officials suggesting 80 percent of the country could be immunized by the end of the year. In Bahrain, however, a vaccination drive that relied heavily on Sinopharm has so far produced at best mixed results and failed to curb a rise in new cases. https://www.washingtonpost.com/world/2021/06/03/bahrain-seychelles-sinopharm-vaccine/
Commiefornia attempting to hold on to every last drop of state power and control right to the end. Even vaccinated workers in California may have to keep masks on https://www.kcra.com/article/even-vaccinated-workers-california-may-have-to-keep-masks/36621274#