U.S. FDA considers approving a second COVID-19 booster shot

(Reuters) -U.S. health regulators are looking at authorizing a potential fourth dose of a COVID-19 vaccine in the fall, the Wall Street Journal reported on Saturday, citing sources familiar with the matter. The Food and Drug Administration has been reviewing data to authorize a second booster dose of the messenger RNA vaccines from Pfizer Inc and partner BioNTech SE and vaccines from Moderna Inc, the report added. The agency last month cut the interval to get a booster dose of COVID-19 vaccines from Pfizer and BioNTech as well as from Moderna, in a bid to provide better protection sooner against the Omicron variant. The planning is still in early stages, and authorization would depend on determinations as to whether the second booster should be authorized for all adults or particular age groups, and whether it should target the Omicron variant or be formulated differently, the report said. It added that no decision was final and that it could be necessary to make booster shots available earlier if a new variant appears. The United States reported 2,323 COVID-19 deaths on Friday, bringing the total count to 936,523. NN: It is settled business typical of these types of vaccines like the flue Jap the vaccine wears off very quickly. In the case of the covid vaccines studies show in 4 to 5 months protection drops dramatically Say you get your booster shot in March. That means your timing would be right to receive the modified to new variants that should be available in August or September. Thats when it looks like the new subvariant BA.2 starts infecting people in mass. For the record its a mistake to open things all the way. Have we not learned anything. Every time they open things up within 6 months another wave is upon us. The BA,2 variant is now dominate in South Africa, India, England and Denmark. A recent Denmark study finds its 30% more infectious than the current variant.an it infects more fully vaccinated people then any other variant. This is very early data.

Meet your new monster the BA.2 Omicron subvarient

https://youtu.be/PoxC0FQGqFQ

(CNN)The BA.2 virus — a subvariant of the Omicron coronavirus variant — isn’t just spreading faster than its distant cousin, it may also cause more severe disease and appears capable of thwarting some of the key weapons we have against Covid-19, new research suggests. New lab experiments from Japan show that BA.2 may have features that make it as capable of causing serious illness as older variants of Covid-19, including Delta. And like Omicron, it appears to largely escape the immunity created by vaccines. A booster shot restores protection, making illness after infection about 74% less likely. BA.2 is also resistant to some treatments, including sotrovimab, the monoclonal antibody that’s currently being used against Omicron. The findings were posted Wednesday as a preprint study on the bioRxiv server, before peer review. Normally, before a study is published in medical journal, it is scrutinized by independent experts. Preprints allow research to be shared more quickly, but they are posted before that additional layer of review.

Continue reading “Meet your new monster the BA.2 Omicron subvarient”

Worst yet to come Omicron is evading vaccines

Omicron is widely known to be more contagious than previous Covid strains. Scientists believe the worst of the virus may not yet be over. In a highly secure clean room at the University of NSW’s Kirby Institute, experts studied the strain at the beginning of Australia’s Omicron wave in mid-December and found out just how adept the variant is at evading vaccines. While the Delta variant was 60 per cent better at evading antibodies than the original virus found in Wuhan – even in the bodies of the double-vaxxed, Omicron was 16.5 times better at evading immunity – 10 times more than Delta. That explains why Omicron surged so quickly when it arrived in Australia – going from 110,000 active cases nationwide on Dec. 30 to 835,000 on Jan. 17. It has since eased significantly, with numbers dropping around 80 per cent since. But while the Omicron wave is subsiding across the globe, scientists believe new variants may continue to emerge for years – particularly in winter. Research from the Kirby Institute shows exactly how much more adept Omicron is at evading immunity via two vaccines or prior infection (pictured). A booster provides more protection Continue reading “Worst yet to come Omicron is evading vaccines”

Moderna eyes COVID booster by August

BRUSSELS (Reuters) – An Omicron-specific booster could be ready by August, the CEO of U.S. biotech firm Moderna told Reuters, but the firm is still gathering clinical data to determine whether that vaccine would offer better protection than a new dose of the existing jab. Last month Moderna began clinical trials for a booster dose specifically designed to target Omicron but initial results from studies in monkeys show the Omicron-specific shot may not offer stronger protection than a new dose of the existing vaccine. Moderna chief executive Stephane Bancel said in an interview the company aimed to have a booster ready by August 2022, before next autumn when he said more vulnerable people may need it. Moderna’s vaccines use mRNA technology to provoke an immune response, similar to the shot developed by Pfizer/BioNTech.

“We believe a booster will be needed. I don’t know yet if it is going to be the existing vaccine, Omicron-only, or bivalent: Omicron and existing vaccine, two mRNA in one dose.”

He said a decision would be made in the coming months when clinical data becomes available. Bancel also confirmed that under the best-case scenario Moderna would have ready by August 2023 a so-called pan-vaccine which would protect simultaneously against COVID-19, flu and other respiratory diseases. He added that pricing for this vaccine under development would be “very similar” to that applied to the current vaccine. Moderna charges different prices for different regions of the world with a range between $15 and $37, according to UNICEF, a United Nations agency involved in the distribution of vaccines to poorer nations. NN: many people are delaying their 4th shot. It is because of bogus information being spread that their will be a booster in March with new RNA targeting the latest variants. That is just not true.Try August! If your last vaccine is more than 4 months old your protection has dropped. Lets face facts we are into a 4 times a year regiment. We are averaging 3 major new variants a year, The latest wave the Omicron variant has run its course. BUT unfortunately its just not that easy. Their are several variants that are warming up in the wings. Do not get all silly on me. Another wave is coming. The messaging has been dismal. Reality is the science is evolving like science is suppose to do. The reason the messaging keeps changing is simple. Their are new mutations and we learn more every day. Its the nature of the beast.

S. Korea: Daily virus cases at new record of 54,941 Germany: 7-day incidence rate at new record of 1474.3

SEOUL, Feb. 12, 2022 (BSS/Xinhua) – South Korea’s daily number of COVID-19 cases hit a record high amid the spread of the Omicron variant, the health
authorities said on Saturday. According to the Korea Disease Control and Prevention Agency (KDCA), the country reported 54,941 more cases of COVID-19 for the past 24 hours, raising the total number of infections to 1,294,205. The daily caseload was up from 53,926 in the previous day, hovering above 50,000 for the third consecutive day. The recent resurgence was driven by infections in the Seoul metropolitan area amid the rapid spread of the Omicron variant, which became a dominant strain here. Of the new cases, 13,189 were Seoul residents. The number of the newly infected people living in Gyeonggi province and the western port city of Incheon was 15,952 and 5,059 respectively. The virus spread also raged in the non-metropolitan region. The number of new infections in the non-capital areas was 20,628, or 37.6 percent of the total local transmission.Among the new cases, 113 were imported from overseas, lifting the total to 27,090. The number of infected people who were in a serious condition stood at 275, up four from the previous day. Thirty-three more deaths were confirmed, leaving the death toll at 7,045. The total fatality rate was 0.54 percent. The country has administered COVID-19 vaccines to 44,725,434 people, or 87.2 percent of the total population, and the number of the fully inoculated people was 44,207,093, or 86.1 percent of the population. The number of those who received booster jabs was 29,244,945 people, or 57.0 percent of the population.

Germany: 7-day incidence rate at new record of 1474.3

Germany’s seven-day incidence rate, which counts the number of people infected with COVID-19 per 100,000 inhabitants, came in at 1474.3 on Saturday, setting a new record high. The figure for new cases of the virus registered daily declined in comparison to the previous days, standing at 209,789. The tally of people that contracted the disease since the beginning of the pandemic thus rose to 12,219,501. Meanwhile, the count of deaths linked to COVID-19 went up by 198 in the previous 24 hours to 119,877.

Covid-Infected HIV Patient Developed Mutations, Study Shows

https://youtu.be/rOF-4Ka_qPI

The study adds to evidence that Covid-19 may mutate rapidly when harboured by immunosuppressed individuals such as those not taking medication to treat HIV, and this may lead to the development of new variants. The Beta variant, with which the patient in the study was infected, was discovered in SA, as was the Omicron variant. “This case, like others before, describes a potential pathway for the emergence of novel variants,” the scientists said, stressing it was a hypothesis. “Our experience reinforces previous reports that effective anti-retroviral treatment is the key to controlling such events.” SA has the world’s biggest HIV epidemic with 8.2-million of its 60-million people infected with the virus which weakens the immune system. The coronavirus harboured by the patient in the study developed at least 10 mutations on the spike protein, which allows it to bind with cells, and 11 other mutations, the scientists said. Some of the changes were common to those seen in the Omicron and Lambda variants while other were consistent with mutations that allow the virus to evade antibodies.

Omicron deaths in USA EXCEED DELTA PEAK

More signs emerged that the Omicron wave is taking a less serious human toll in Europe than earlier phases of the pandemic as U.S. data showed daily average deaths from the disease exceeding the peak reached during the surge driven by the previously dominant Delta variant. In the U.S., the seven-day average for newly reported Covid-19 deaths reached 2,258 a day on Tuesday, up about 1,000 from daily death counts two months ago, data from Johns Hopkins University show. That is the highest since February 2021 as the country was emerging from the worst of last winter’s wave. While there is a large body of evidence suggesting that Omicron is less likely to kill the people it infects, it spreads much more quickly and therefore infects many more people than earlier variants, epidemiologists say. Continue reading “Omicron deaths in USA EXCEED DELTA PEAK”

Fourth COVID vaccine shot raises resistance to serious illness for over-60s: Israel

A fourth dose of Covid-19 vaccine given to people over 60 in Israel made them three times more resistant to serious illness than thrice-vaccinated people in the same age group, Israel’s Health Ministry said on Sunday. The ministry also said the fourth dose, or second booster, made people over 60 twice as resistant to infection than those in the age group who received three shots of the vaccine. A preliminary study published by Israel’s Sheba medical centre last Monday found that the fourth shot increases antibodies to even higher levels than the third but “probably” not to the point that it could completely fend off the highly transmissible Omicron variant. Israel began offering a fourth dose of the Pfizer/BioNtech vaccine to people over 60 earlier this month as Omicron swept the country. The ministry said on Sunday the study it conducted with several major Israeli universities and the Sheba centre compared 400,000 people over 60 who received the second booster with 600,000 people in the age group who were given a third shot more than four months ago. As elsewhere, Israel has seen Covid-19 cases spiral due to Omicron. But it has logged no deaths from the variant.

Only one antibody treatment works against omicron — and it’s running out

As the omicron variant became the dominant strain in the U.S. this week, health care providers are left with fewer options to treat positive COVID-19 patients as most of the existing treatments have been found to be less effective in fighting off the new variant. Up until recently, the U.S. Department of Health and Human Services (HHS) had been distributing three types of COVID-19 antibody treatments, Regeneron monoclonal antibodies, Eli Lilly’s antibody treatments and GlaxoSmithKline’s sotrovimab monoclonal antibody. Regeneron gained national attention when former President Trump contracted COVID-19 and was treated with Regeneron under a “compassionate use program” that allowed rare, exceptional circumstances to use the treatment. However, as omicron emerged and scientists around the world scrambled to understand how current vaccines and available therapies could fight the new variant, Regeneron and Eli Lilly both announced their antibody treatments didn’t work as effectively in diffusing omicron. On Dec. 16, Regeneron announced its antibody treatment had “diminished potency against omicron.” In a statement to a local Fox News station, Eli Lilly confirmed that its antibody treatments showed “reduced neutralization activity,” against omicron. That leaves one COVID-19 treatment available to treat omicron infections, and in early December, GlaxoSmithKline (GSK) announced that its sotrovimab monoclonal antibody “retains in vitro activity against the full known omicron spike protein.” Meaning that GSK’s treatment could fight against all tested variants of COVID-19. It gained emergency use authorization by the U.S. Food and Drug Administration in May this year. George Scangos, CEO of Vir, the company partnering with GSK to develop sotrovimab, told The New York Times that when developing their antibody treatment they looked at the blood of people who had survived the 2003 SARS epidemic, instead of those who survived COVID-19 infections. Through this method, they identified an antibody from SARS that could also protect against the coronavirus that caused COVID-19. “I think we got here not by good luck, but by a thoughtful process,” said Scangos. However, currently health care providers are left with slimmer treatment options, as HHS data indicates that as of Dec. 17 the government had stopped distribution of Regeneron and Eli Lilly’s COVID-19 treatments and had only shipped 55,000 GSK treatments. Since mid-September, the HHS had shipped 1.2 million doses of Regeneron to states and around 670,000 doses of Eli Lilly’s antibody treatment.

According to the Times, hospitals in New York have recently said they would also stop giving patients the two most commonly used antibody treatments, made by Regeneron and Eli Lilly.

Ralph Madeb, New York Community Hospital’s co-chief medical officer said, “if I had a choice I would give GSK.” Supply of GSK’s sotrovimab monoclonal antibody is currently limited, but the White House is in discussions with the pharmaceutical company to secure more doses that could be delivered early next year, according to the Times. Along with sotrovimab, federal regulators are expected to authorize antiviral pills from pharmaceutical companies Pfizer and Merck, which would add to health care providers’ toolbelt of treatment options for COVID-19 patients.

Mosh Staff member tested positive with Symptoms

Mosh part of our research staff is in isolation with symptoms. Mosh refused to get his 3d shot never mind his fourth. After his second shot he became fixated on the rare Myocardial Infarction COVID-19 Vaccine Side Effect. Of course he was banned from the compound. The last time he was here (last week) he was not allowed to enter the compound and he did not have on our “ugly” mask with the ULPA biolab filters we developed. He trusted the CDC guidelines to use the coffee filter SHIT N95 ha ah ha ha ha mask. In the strongest terms available to me I warned him. As is often the case with millennials he did not listen. Muttering something about he was staying away from people……. I guess that did not work out so well for him…… Friday he came down with symptoms and used one of our antigen test kits to confirm he is infected. He is very tired and has flue like symptoms. Mosh is severely overweight and pre diabetic. I AM VERY WORRIED. We do not require staff to be vaccinated it a personal choice. But we recommend vaccination, isolation, “ugly” mask and our immune system booster vitamins it in the strongest possible terms. Back to Mosh. We have our staff Doctor prescribe a 5 day course of Ivermectin AND we are striving to get him the only big pharma monoclonal antibody treatment that works. Sotrovimab by GlaxoSmithKline cost $3000 if you can find it. I am worried… I AM WORRIED. I take keeping you all healthy as Job1…. Job2 is making you wealthy.