Covid-19: Treatments, Cures, and Vaccines

AstraZeneca to seek EUA from the FDA for its antibody combo drug targeted for use in those who do not tolerate the vaccine or are immunosuppressed.


"AstraZeneca has requested emergency use authorisation from U.S. regulators for its new treatment to prevent COVID-19 for people who respond poorly to vaccines because of a weakened immune system.
In a statement on Tuesday, the Anglo-Swedish drugmaker said it included data in its filing with the Food and Drug Administration from a late-stage trial that showed the drug reduced the risk of people developing any COVID-19 symptoms by 77%.
The antibody therapy called AZD7442 could protect people who do not have a strong enough immune response to COVID-19 vaccines or to supplement a vaccination course for those, such as military personnel, who need to booster their protection further, AstraZeneca has said.
While vaccines rely on an intact immune system to develop targeted antibodies and infection-fighting cells, AZD7442 contains lab-made antibodies designed to linger in the body for months to contain the virus in case of an infection."

https://news.yahoo.com/astrazeneca-files-u-approval-drug-062420195.html

 

It's amazing how quickly these drugs have made it to the market. Crazy how fast things can go without a million regulatory hurdles. Sure, we need to make sure of safety and efficacy, but I think the fact that these drugs were developed, made and distributed so fast shows just how much red tape there is when it normally can take a decade for a drug to get to market.

 

They are throwing an inordinate amount of taxpayer money at this. Outside of cancer or aids, i doubt any disease has had nearly this amount of govt $$$ thrown at it for funding R&D. Esp in such a short amount of time.

 

Development money has nothing to do with the amount of time and regulations that are normally required to bring a drug to market. There are ridiculous wastes of time by the FDA when it comes to medical devices and drugs that have nothing to do with efficacy and safety. It can take up to 6 months to get simple questions answered by the FDA. The fact that these drugs are being zoomed through shows just how inefficient and bureaucratic the FDA is. They're inefficiency is one of the main factors that adds to the exorbitant cost of developing drugs.

 

https://www.nejm.org/doi/full/10.1056/NEJMoa2114583?query=featured home


Study of Israel data shows Pfizer vaccine tends to wane faster for men vs women and old vs young.

 

In fairness, many other drug reviews are being delayed, however, your point is well taken. The FDA is choked with gross inefficiency.

On the other hand, the copies amounts of money are enabling vast, well organized trials that are expediting data collection and question answering.

I think it is going hand and hand in this case.

 

I think another factor that allowed things to move so quickly is the vast number of trial candidates and the ease of signing them up.

My issue with the FDA is the needless waste of time and the antiquated way they do things. Sometimes something as simple as a quick email reply can save companies hundreds of thousands to millions of dollars and months and months of time. I remember when a company I worked for wanted to change the color of a label on one of our products that had zero to do with safety and efficacy of the product and it took nearly 8 months to get an OK from the FDA. And FDA rules give them up to six months to reply to questions company's may have about NDAs. You always can count on them delivering the answer to your questions on the very last day of that 6 month period.

 

My ex wife was a pharmacist. She knew more about medication than almost every doctor I have ever been to. Not sure why she used to make me foxglove tea though. Jk

 

Was she a beneficiary of your life insurance?

FOXGLOVE: Overview, Uses, Side Effects, Precautions, Interactions, Dosing and Reviews
Also, jk

 

I wouldn’t say the FDA is “efficient” by any measure, but this is hardly a model for what an agency like FDA could typically do either (or how we’d ideally want them to operate). COVID drugs are effectively cutting in line on process, they are cranking out emergency use authorizations as soon as the trials are done.

Odd that you think $10’s of Billions has “nothing” to do with it. That money allowed the drug producers to blow right into phase 2 and 3 as soon as a safety profile was established, and the financial backing allowed them to have everything ready to be manufactured at scale without worrying about a failed trial at an earlier stage. So even before we get to “emergency use authorization” which itself is a fast tracked approval, the entire process is expedited and not repeatable without that $$$ and emergency prioritization.

 

Delta does not appear to make children sicker; Secondary immune response stronger after infection than after shot (msn.com)

Delta variant does not appear to make children sicker

The Delta variant of the coronavirus does not appear to cause more severe disease in children than earlier forms of the virus, a UK study suggests. Earlier this year, the research team found the Alpha variant of the virus did not appear to make children sicker than the so-called wild, or original, form of the virus, first seen in China. New data suggests that kids also do not get any sicker from Delta than they did from Alpha. Researchers compared two groups of school-age children with COVID-19: 694 infected with the Alpha variant between late December 2020 and early May 2021, and 706 infected with Delta between late May and early July. As reported on Thursday on medRxiv Illness characteristics of COVID-19 in children infected with the SARS-CoV-2 Delta variant ahead of peer review, children infected with Delta had slightly more symptoms. But in both groups, very few children needed to be hospitalized and long periods of illness were uncommon. In both groups, half of the children were sick for no more than five days. The researchers lacked information on differences between the groups that might have influenced the results, such as whether lockdowns were in place, and the effects of different seasons. "Our data suggest that clinical characteristics of COVID-19 due to the Delta variant in children are broadly similar to COVID-19 due to other variants," the researchers concluded. That appears to jibe with data reported by the U.S. Centers for Disease Control and Prevention (CDC). "Although we are seeing more cases in children ... these studies demonstrated that there was not increased disease severity in children," CDC Director Dr. Rochelle Walensky said of the Delta-driven wave in a statement. "More children have COVID-19 because there is more disease in the community."

Secondary immune response stronger after infection than vaccination

In COVID-19 survivors, important components of the body's immune response called memory B cells continue to evolve and get stronger for at least several months, producing highly potent antibodies that can neutralize new variants of the virus, a new study has found. By comparison, vaccine-induced memory B cells are less robust, evolving for only a few weeks and never "learning" to protect against variants, researchers reported in a paper published on Thursday in Nature https://go.nature.com/3AjGx2B. COVID-19 vaccines do induce more antibodies than the immune system does after a coronavirus infection. But the immune system response to infection appears to outshine its response to vaccines when it comes to memory B cells. Regardless of whether antibodies are induced by infection or vaccine, their levels drop within six months in many people. But memory B cells stand ready to produce new antibodies if the body encounters the virus. Prior to this study, there had been little data on how vaccine-induced B cells compare to infection-induced B cells. The researchers caution that the benefits of stronger memory B cells after infection do not outweigh the risks that come with COVID-19. "While a natural infection may induce maturation of antibodies with broader activity than a vaccine does, a natural infection can also kill you," said study leader Michel Nussenzweig of Rockefeller University, in a statement. "A vaccine won't do that and, in fact, protects against the risk of serious illness or death from infection.

 

Wrong thread for this....please move this discussion to the appropriate thread. Thanks.

 

Covid News: New Study Finds Pfizer Vaccine Provides Strong Protection Against Hospitalization


https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02183-8/full text

The Pfizer-BioNTech coronavirus vaccine is 90 percent effective at preventing hospitalization for up to six months, with no signs of waning during that time period, according to a large new U.S. study conducted by researchers at Pfizer and Kaiser Permanente.

The vaccine also provides powerful protection against the highly contagious Delta variant, the scientists found. In a subset of people who had samples of their virus sequenced, the vaccine was 93 percent effective against hospitalization from Delta, compared with 95 percent against hospitalization from other variants.



The vaccine’s effectiveness against infection did decline over time, however, falling from 88 percent during the first month after vaccination to 47 percent after five months.

 

Merck and Ridgeback announce that they have filed for EUA for Molnupiravir to treat mild or moderate COVID in adults and who are at risk of the disease worsening.

https://www.usatoday.com/story/news...molnupiravir-antiviral-pill-cases/6083682001/

 

Interesting commentary by a couple of HIV virologists. They are very concerned the virus can/will quickly adapt to the RNA protease inhibitor (Molnupiravir) and become immune to it. HIV did the same thing at first. They are suggesting that the RNA Protease inhibitor will have to be placed with a Protease inhibitor (Pfizer is in Phase 3 trials now) and a third drug like Ritanovir (used in HIV to keep the active anti-viral drugs in the system longer). Should be interesting to watch this all unfold.

Additionally, the drug Molnupiravir reduced the liklihood of COVID to progress to severe disease by 50% over the control group. However, there were ZERO deaths in the Molnupiravir group while there were 8 deaths in the control group. These results are pretty exciting.

 

The regeneron clinic in Jacksonville has slowed to a crawl this week. Initially 300 plus were utilizing the free treatment before dwindling down by about 100 people per day to the point that we are only seeing between 40 to 80 people a day now. Most who have been utilizing the treatment are unvaccinated or partially vaccinated who either have covid or were exposed. Seems as though many are unaware the treatment centers exist and there has been very little public education about their existence. Just a bit of random info.

 

What was the wait time for a treatment at the peak? Just curious, since you are correct, very little coverage about such a good free service.

 

In the beginning they only had 3 registration stations so there was a wait. They have up to 13 now and there is no wait time. In fact we have to scale back now due to low volume.

 

AZ atnibody cocktail showed excellent results when given in the first week of infection, as well as it has shown excellent results in a separate trial where it was used to prevent disease when given to those exposed to COVID but not yet demonstrating symptoms.

AstraZeneca antibody cocktail study shows success treating COVID-19

 

Interesting over a decade of Tamiflu and there is some resistance but not much.