Slow down buddy. India hasn't even published Phase II results (which China published a few in July), lets not even talk about Phase III. Besides, China's vaccines were submitted to COVAX and will likely be approved before the western ones.
Coronavirus 2019-2020 thread (no unsubstantiated rumours!)
- Thread starter localizer
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Slow down buddy. India hasn't even published Phase II results (which China published a few in July), lets not even talk about Phase III. Besides, China's vaccines were submitted to COVAX and will likely be approved before the western ones.
Is there any record of people having very little to no reaction to the vaccine? It would be interesting to know if the Moderna and Pfizer type of vaccines are producing the more severe reactions because of the type of vaccines they are, whereas the more traditionally made vaccines elicit less serious reactions?Anyway it would be nice to have a choice of vaccine types from which we can individually choose.
vesicles
Colonel
Well, if you look at Pfizer's published clinical data (link below), Figure 2 shows that about 70-80% of the subjects who received the actual vaccine (as opposed to a placebo) experienced some degree of side effects. So to answer your question, ~ 20% of people won't feel anything. Based on my own experience, almost everyone that I've talked with experienced some discomfort. The most common would be a sore arm. Almost everyone has had it. And local pain at the injection site is expected since this is a typical immune response to a vaccine. The pain is a signal that our immune cells are generating the appropriate cytokines, which stimulates the ion channels and pain receptors. That leads to pain. So this means the appropriate antibodies must have been made along the way since antibody generation is a part of this whole process. The sensation of pain is generated to warn us to protect the "infected sites" and to be careful about our activities. It's a warning signal associated with the whole complex immune response.
Even before vaccination, I myself sorta wished that I would at least have a sore arm. This would mean the vaccine is definitely working. Of course, feeling nothing at all does NOT mean the vaccine is not working. Everyone is different. Your immune system may react in different ways. Also, everyone's pain threshold is different. With the same level of pain, one person may react as if this is the end of the world, while another one may not feel a thing... So it's possible that you simply have a higher threshold for pain and discomfort and don't feel the responses your muscles are signaling to you.
About the potential comparisons between new-tech vaccines and traditional vaccines. I haven't seen any data with the traditional vaccines just yet. With that being said, I don't expect to see any significant differences. Why? Our body is not responding to the genetic materials injected into us. We are responding to the viral proteins generated from the genetic materials, namely the spike protein of the virus. And with the traditional vaccines, our body is responding to the same proteins. I would expect a similar levels of side effects. We will find out soon when the clinical data of the Chinese vaccines come out, hopefully soon.
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vesicles
Colonel
A UK study of 46,000 healthcare workers (13,000 vaccinated vs. 33,000 unvaccinated) shows that those with only the first shot of the Pfizer vaccine were 50% less likely to get infected. This is actually closer to the clinical trial data. I know that this is different from the ~33% efficacy from an earlier Israeli study. But this is real-world data. Some variations make sense. A good development.
In Israel, they've vaccinated 90% of people older than 60. And this group is showing a 40% drop in infection. This is not observed in younger groups, majority of which has not been vaccinated at all. Also, the current lock down may not be a factor in the observed drop in the >60 group since a similar lockdown back in September last year (before vaccines) did not yield any significant changes in infections among the >60 people. A good development.
Sinovac needs to explain why the efficacy rate is not consistent or even close for these two trials.
The phase III trials conducted in Brazil and Turkey evaluated the efficacy of the vaccine candidate in healthcare workers who provide treatment to COVID-19 patients. Both trial studies were randomized, double-blind, and placebo-controlled. The two trials shared the same primary endpoint of an efficacy rate 14 days after the vaccination with either vaccine candidate or placebo.
As of December 16, 2020, there were 12,396 health workers over 18 years old enrolled. A total of 253 positive cases were collected during the observation period. After 14 days following vaccination with 2 doses of vaccine following a 0, 14 day schedule, the efficacy rate against diseases caused by COVID-19 was 50.65% for all cases, 83.70% for cases requiring medical treatment, and 100.00% for hospitalized, severe, and fatal cases.
There are two stages of the phase III clinical trial in Turkey. Participants comprised health care workers in the first stage (K-1) and the general population in the second stage (K-2), with all participants ranging from 18 to 59 years old. As of December 23, 2020, there were 918 participants enrolled in K-1 and 6,453 participants in K-2, for a total of 7,371 participants. Among them, 1,322 participants completed the two-dose vaccination and entered the 14-day observation period after receiving the second dose of the vaccination. Based on an analysis of 29 cases, the efficacy rate for COVID-19 prevention was 91.25% after 14 days following the two-dose vaccination, in adherence with the 0, 14 day schedule.
Sinovac has officially filed conditional market authorization for CoronaVac with China’s National Medical Products Administration (NMPA). Sinovac continues to actively seek regulatory approval for CoronaVac in other countries while contributing to making the COVID-19 vaccine accessible and affordable on a global basis to ensure the prevention and control of the COVID-19 pandemic.
Sinovac Announces Phase III Results of Its COVID-19 Vaccine
BEIJING--()--Sinovac Biotech Ltd. (NASDAQ: SVA) (“Sinovac” or the “Company”), a leading provider of biopharmaceutical products in China, today announced phase III results. Sinovac had started its phase III trials on CoronaVac, its COVID-19 vaccine, on July 21, 2020. Trials were conducted in Brazil, Turkey, Indonesia, and Chile. In compliance with the principles of Good Clinical Practice (GCP), the trials were conducted with the vaccine candidate produced from the same lot and following the 0, 14 day schedule. There have been a total of 25,000 participants enrolled in the trial across those four countries.The phase III trials conducted in Brazil and Turkey evaluated the efficacy of the vaccine candidate in healthcare workers who provide treatment to COVID-19 patients. Both trial studies were randomized, double-blind, and placebo-controlled. The two trials shared the same primary endpoint of an efficacy rate 14 days after the vaccination with either vaccine candidate or placebo.
As of December 16, 2020, there were 12,396 health workers over 18 years old enrolled. A total of 253 positive cases were collected during the observation period. After 14 days following vaccination with 2 doses of vaccine following a 0, 14 day schedule, the efficacy rate against diseases caused by COVID-19 was 50.65% for all cases, 83.70% for cases requiring medical treatment, and 100.00% for hospitalized, severe, and fatal cases.
There are two stages of the phase III clinical trial in Turkey. Participants comprised health care workers in the first stage (K-1) and the general population in the second stage (K-2), with all participants ranging from 18 to 59 years old. As of December 23, 2020, there were 918 participants enrolled in K-1 and 6,453 participants in K-2, for a total of 7,371 participants. Among them, 1,322 participants completed the two-dose vaccination and entered the 14-day observation period after receiving the second dose of the vaccination. Based on an analysis of 29 cases, the efficacy rate for COVID-19 prevention was 91.25% after 14 days following the two-dose vaccination, in adherence with the 0, 14 day schedule.
Sinovac has officially filed conditional market authorization for CoronaVac with China’s National Medical Products Administration (NMPA). Sinovac continues to actively seek regulatory approval for CoronaVac in other countries while contributing to making the COVID-19 vaccine accessible and affordable on a global basis to ensure the prevention and control of the COVID-19 pandemic.
Quite simple, 253 positives in the Brazilian trial and 29 cases in the Turkish trial.
Turkish trial needs more subjects.
Both need more subjects tbh.
Also the Brazilian trial was all healthcare workers who were likely exposed to higher viral load thus worsening overall outcome.
Sinopharm trial was much more comprehensive (>60000 subjects) and across 10 countries.
I'd like to think Sinovac's vaccine efficacy is similar in efficacy to Sinopharm's due to similar technologies. Both are inactivated vaccines with alum adjuvants.
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Did the efficacy in the Brazilian trial rise from 50.4% to 50.65%? This is a rare case where such a small change is actually important. Since it rounds up to 51% and 51% sounds a lot better than 50%. With 50%, it sounds like 'oh it only works half the time', whereas with 51%, it sounds like 'it works most of the time.' It's silly, but psychologically important.
I’m not sure China is doing this out of the goodness of its heart. Those vaccines do cost money you know. It isn’t like they are being given away for free.
That's why I am puzzled why Sinovac released this interim result now. It isn't like we didn't already know these results. What Sinovac needs right now is clarification.
Cansino is moving forward and seeking approval from Mexico. The biggest advantage of CanSino it is that it requires only one dose. Russia is seeking cooperation with CanSino for combining its Sputnik with Cansino vaccines.