Yup. We are about to be up to our noses in vaccine doses if J&J and Astrazenca are both here around the same time.
The new coronavirus variant identified in South Africa poses even more of a risk than the strain discovered several weeks ago in England, Britain's top health official warned on Monday. His alarm came as scientists warned that the new strain sweeping through South African coastal communities could be resistant to the COVID-19 vaccines approved or awaiting approval in the U.S. and Europe. "I'm incredibly worried about the South African variant," Health Secretary Matt Hancock told BBC Radio. "This is a very, very significant problem... it's even more of a problem than the U.K. new variant." https://www.cbsnews.com/amp/news/covid-vaccine-new-strain-south-africa/
Some commentary on that UK study that showed zero reinfections among previously infected healthcare workers over a 6 month period. Extremely good news.
Well, the FDA made a statement yesterday that basically shut that door. Lack of data = risk. Risk adverse recommendation. FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines | FDA We have been following the discussions and news reports about reducing the number of doses, extending the length of time between doses, changing the dose (half-dose), or mixing and matching vaccines in order to immunize more people against COVID-19. These are all reasonable questions to consider and evaluate in clinical trials. However, at this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence. Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19. Those participants who did not receive two vaccine doses at either a three-or four-week interval were generally only followed for a short period of time, such that we cannot conclude anything definitive about the depth or duration of protection after a single dose of vaccine from the single dose percentages reported by the companies. Using a single dose regimen and/or administering less than the dose studied in the clinical trials without understanding the nature of the depth and duration of protection that it provides is concerning, as there is some indication that the depth of the immune response is associated with the duration of protection provided. If people do not truly know how protective a vaccine is, there is the potential for harm because they may assume that they are fully protected when they are not, and accordingly, alter their behavior to take unnecessary risks. We know that some of these discussions about changing the dosing schedule or dose are based on a belief that changing the dose or dosing schedule can help get more vaccine to the public faster. However, making such changes that are not supported by adequate scientific evidence may ultimately be counterproductive to public health. Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that health care providers follow the FDA-authorized dosing schedule for each COVID-19 vaccine.
On the FDA's defense, we Americans as a whole are stupid. Unless the single dose is as effective as two doses, any gains by doing one dose first will be undone by Americans gone wild.
It is not. But a single dose is more effective than the 50% threshold (from limited data) that the FDA had set for themselves. I think their argument of unknown risk that could be counterproductive is perfectly fine. Of course, covid IS an ongoing dangerous public health crisis so I would prefer to see a real attempt at weighting the risk and reward of delaying the 2nd dose vs it’s risky because we don’t have data from the “companies”.
If I recall correctly there was only 1 severe case between the 1st dose and 2nd dose in all of the trials. In those videos I have posted that doctor gets into the data from the trials. The reason why UK has decided to wait 3 months in between doses is because the data from the trials seems to indicate no difference or even a possible benefit (stronger antibody response) from waiting longer in between dosing. We don't know the optimal length of time between doses and it's a bit of an experiment, but seemingly a low risk experiment based on prior data. A single dose is FAR more effective than zero doses and would seem to nearly end severe cases of covid.
I'm not worried about the people that get the first dose. I'm worried about the stupid people making it more dangerous for the elderly who can't get first dose as they are not internet savvy and have difficulty competing with others in getting what's available. Get the elderly and other high risk groups both doses before unleashing the general public. At that point, I don't care as much. Not everyone is going to get vaccinated and I worry that the stupid is faster than distribution once it goes public.
Astrazenca is supposed to be by April. No clue why April considering the fact that UK and India have already approved it. J&J no clue but it sounds like possibly sooner. https://www.khou.com/article/news/h...tion/285-5aec885b-1d5f-4a9e-a00e-0f5da893035c Johnson & Johnson's single-dose vaccine next to seek emergency use authorization Experts say Johnson & Johnson’s vaccine could be a game-changer since it only requires one shot and does not require ultra-cold storage, like the Pfizer shots. HOUSTON — Johnson & Johnson says it plans to seek emergency use authorization in February, which would make it the third vaccine to be considered by the FDA. The shot was developed by Janssen Pharmaceuticals, a Belgium based division of Johnson & Johnson. It would be the first COVID-19 vaccine that only requires one dose. Johnson & Johnson’s adenovirus-based vaccine works differently than Pfizer and Moderna’s vaccines, which use messenger RNA. Doctors say it produces an antigen, or protein, which causes an immune response to protect against the novel coronavirus. The same technology was used to develop the Ebola vaccine. Experts say Johnson & Johnson’s vaccine could be a game-changer since it only requires one dose and does not require ultra-cold storage, like the Pfizer shots. More than 45,000 people over 18 are enrolled in the third phase of the clinical trial for the vaccine. According to a press release from Johnson & Johnson, preliminary results showing the vaccine's safety and efficacy are expected to be released by the end of January. If the FDA grants emergency use authorization, Johnson & Johnson says it plans to manufacture more than a billion doses to be distributed globally by the end of 2021.
My mom was contacted by UT health center to schedule her dose and she is getting it tomorrow. They called her today and they could have got her in today if she was able to make it. My dad said the VA has been contacting his old Army friends to setup shots. He was also chatting with his ex-wife who complains about everything and found where she can get vaccinated in Florida. I think a lot of it at this point is word of mouth, but I think things will become more organized over the couple of weeks based on my mom's experience. She basically did nothing and was contacted proactively.
There are about 15 of them in some stage of "phase 3" testing or approval state worldwide. Most of those are Chinese, Indian, or Russian, so it's unclear whether we'll see enough valid data results, and even if we did, even more debatable in some cases, whether they'd see the light of day in the US. lol. Many of them also use "old-school" inactivated viruses, too. This leaves about 2 in phase 3 that I know of that could see the light of day in the US "soon" : Curevac's and J&J/Janssen's vaccine candidates. Both should be in the next 1-3 months, I think. Jannsen/J&J's was supposed to be next. A few other ones are Canada's Medicago/GSK attempt which I think is in either Phase 2/3 being and id derived from the tobacco plant. Philip Morris is supplying some of the funding for that one (lol). Novavax just started enrolling people for Phase 3, I think in the US. Lastly Japan had one in Phase 3 -- can't remember who that was or if anything new was announced, however.
I went ahead and got the vaccine today, wasn't going to because I've had the real thing before and I'm in a very low risk group, but there was only a few hours till a batch was set to expire so I got one rather than have it go to waste.
