The development, evaluation, approval and monitoring process is described in detail here: https://www.ema.europa.eu/en/human-regulatory/overview/publi...
And on to of that Russia and China are much further behind in the rollout to their own population than the EU itself - see https://ourworldindata.org/grapher/covid-vaccination-doses-p...
This is based on the theory that the immune system response to Oxford's virus vector is mostly negating the benefit of the second dose taken 21 days after the first. Gam-COVID-Vac gets around this by using different viruses for each dose, and has 90% efficacy results from their Phase III trial. Unfortunately, no one can yet manufacture it in anything like bulk quantities, but they have set up manufacturing partnerships with a whole bunch of countries from India to South Korea.
France allowed the Pasteur institute to fail - a much desired vaccine was stopped because it wasn't effective enough. Impossible to imagine the same happening in Russia, as Putin needs to project power.
Do you know if there are more trials underway to verify this? I'm guessing it ties in to AZ's encouragement for delaying the second dose i.e. wait until the immune response has died down. I think UK medical consensus is currently recommending 12 weeks rather than the original 3-4.
But what use is that when the availability of the vaccine will remain so limited for the foreseeable future? When the producers are unable to deliver what they have agreed to – or can only deliver much later?"
Personally, I blame part of the availability issues, caused by the Pfizer plant "shutdown" in Belgium, on that hatchet job. The Spiegel was among the first to use the unsatisfactory vaccine availability against von der Leyen. Fair enough, but as solution they called for increased ordering. Pressure built, frustration kicked in and then every news outlet demanded the same thing. Local politicians supported that narrative, they avoided discussions about their own fuck ups. Then the EU ordered more, demand exceeded capacity, and Pfizer reworks its plant. That resulted in even worse short term availability issues. So great job, I guess.
In terms of effect on effectiveness per person it is purely speculative.
Exploratory analyses showed that increased immunogenicity was associated with a longer dose interval (see Immunogenicity Table 3). Efficacy is currently demonstrated with more certainty for dose intervals from 8 to 12 weeks. Data for intervals longer than 12 weeks are limited.
https://www.gov.uk/government/publications/regulatory-approv...
As such the decision was very clearly made on the basis of getting more people some protection, whether or not they could be confident of the effect of the long term protection across the various vaccines.0
It's a reasonable gamble to take given the amount of spread, and is not a criticism (though the way the change was communicated was absolutely awful), but if it had been a decision taken based on available data one would expect the schedules actually tested by the manufacturers to be adhered to, even if different between the vaccine.
The Russian vaccine's "trial" was mostly a non-consensual trial carried out on their military. I expect this lowered confidence.
Does China have a vaccine with decent effectiveness yet? Last time I read about it, the number was around 50%.
https://www.google.dk/amp/s/mobile.reuters.com/article/amp/i...
Not on efficacy, but in reported efficacy. Basically: if you're willing to be unethical about testing X, why would we trust you to be ethical when reporting about X.
You can say that results are unreliable because they're not open about the details, or didn't provide enough data, or the data they provided doesn't make sense. Vaccinations being consensual or not is unrelated to the topic.
At least one EU country will soon be getting them. Hungary has approved [1] and also ordered [2] the Russian vaccine. Hungary has also approved [3] but not yet ordered the Chinese vaccine.
[1] https://www.dw.com/en/covid-hungary-fast-tracks-russian-vacc...
[2] https://www.aljazeera.com/news/2021/1/22/hungary-buys-russia...
[3] https://www.reuters.com/article/us-health-coronavirus-vaccin...
Obviously these magical mRNA vaccines with their 95% numbers are going to be more effective. But that's just a (very) happy scientific accident that they worked out. Historically vaccines haven't been anywhere near that effective and have still controlled disease. Hell, the flu shots we get are like 30% effective and they still save lives every year.
Well, last night a reputable Israeli HMO posted it’s real world data for Pfizer, and it’s 50% after 18 days and doesnt seem to get much better (but they don’t have enough data yet to know for sure).
And now, although everyone claims Pfizer says you get 50% after 1st dose and 95# after second, if you read the actual filing, that’s not what it says; efficiency is achieved at day 13 by Pfizer data almost fully; and the reduction in severe disease (the only interesting endpoint) is 75% with confidence interval 0-100%
The type of vaccine Israel has mostly used is the Pfizer/BioNTech vaccine with a small number of doses from Moderna. The two vaccines use the same technology, and in clinical trials were found to be about 95% effective. " https://edition.cnn.com/world/live-news/coronavirus-pandemic... Can you share your datasource claiming that efficacy is only 50%?
You’ll have to actually read it, or find a tldr from someone who knows what they are doing.
The same calc that leads to 0.04% above would say overall covid mortality is 0.08% and is intentionally misleading - but no news media so far (in Israel or outside) has done any review. They are all parroting the misleading numbers.
Anything but primary data these days is suspect. (Pfizer’s own primary data, btw, says severe disease is 75% RRR with CI 0-100%. Did you see anyone reporting on that?)
Edit: to add: Israel is an a horrible bind right now. The vaccine is only 50% effective but gov has done very badly in handling the disease and promoted the vaccine as “our way out”, so the gov is attempting to hide that data. Unfortunately for them, Israel is too small and the culture not supportive of hiding this, even if at this point the mass media is cooperating with the government.
"We demonstrated an effectiveness of 51% of BNT162b2 vaccine against SARS-CoV-2 infection 13-24 days after immunization with the first dose. Immunization with the second dose should be continued to attain the anticipated protection."
I.e. if you take only the first dose of the two required then 13 days after taking it you already get an effectiveness of 50%. Therefore they recommend that people take the 2nd dose as prescribed. They don't mention effectiveness one week after the 2nd shot, which is what Israel considers to be immune (i.e. "green passport" status).
For severe disease, Pfizer had 4 in the control group, and 1 in the vaccine group. That’s 75% RRR, with a confidence interval that spans 0-100%.
Look at the graphs here and in Pfizer’s. Immunity seems to taper at 12-18 days and stay there. The 2nd vaccine does not seem to confer more immunity - just expected to last longer time. This article looks at more severe disease than Pfizer’s 95% endloint (though possibly not severe as their “severe disease” endpoint - I don’t remember what definition each uses, but just in Israel the “severe” definition has changed several times)
50% efficacy after the first dose is exactly the number that BioNTech reported in its Phase3 trial. So nothing unusual here. That is why the 2nd booster shot is needed to get to 95%.
The graphs, both in Pfizer’s original report and in this paper, show that past about two weeks, there is almost no change. Please look at the Pfizer graphs and tell me where the great advance is from 50% to 90%
Also, if yo actually read the Pfizer report, you’ll notice the 95% is for mild disease - a totally uninteresting result. For severe disease, it is 75% with a CI spanning the whole 0-100% range.
(1) If am right, then Covid is gone in Israel by end of March.
(2) If you are right, Covid will be still a huge problem in in Israel.
Also, there's a nature paper from last week that shows incredible correlation between Sun UVB at 34% of equator and the date that a wave starts. Covid will be gone by June, just like last year, thanks entirely to that effect (and possibly arrive again in Sep/Oct, or not). I'm not interested in meterology, but it's possible that even if I'm right, by end of March covid will be very dim in correlation with UVB exposure.
The amount of data actually attributable to cause and effect is incredibly miniscule. I do data science for a living. The headlines are basically all wrong, most discussions are, and quite a bit of the primary data cannot be right.
added: p.s - Did you actually read the papers before calling me a lier (or after?) or just did it based on headlines. I'm not holding it against you either way, just wondering.
Their initial results are actually very encouraging[0] in this regard.
[0] https://www.ynetnews.com/health_science/article/Hk2URcnku
The Israeli government failed miserably in dealing with covid. They were successful in getting the vaccines (and thanks to the HMOs and no thanks to the government, deploy them quickly) and selling the hopium that this will solve everything and make up for the failure so far.
So now they are in a very bad place. If they admit the real stats publicly before the vaccine project is done, people will stop getting vaccinated (not because 50% effective is bad - but because they’ve been misled). No one wants that. I suspect that’s why the media (ynetnews - a local USA Today equivalent, included) are all parroting the official statements without review comment or criticism.
The numbers in the ynetnews are not false but they are (likely intentionally) misleading. If you used the same arguments, you’d get an IFR that’s way lower than the flu, for example. They cherry picked a completely meaningless statistic that looks good, and claimed it is the vaccine efficiency. It is not.
They even say so explicitly:
> Second, our case definition was positive SARS-CoV-2 PCR test irrespective to presenting symptoms that defined COVID-19 cases in the RCT. This might explain the discrepancy in results.
So, this new research is not really contradicting the Pfizer paper in any way - they are simply measuring different quantities.
Still, it's nice to know that the vaccine also offers protection from infection, not just the disease.
Ynet is Yediot, which is either the biggest daily newspaper or the second-biggest depending on how you count, either way it has more influence than Yisrael-Hayom. They do neglect their English site, but this particular content matches their Hebrew publication. It can't be seriously compared to USA Today (which is one of those magazine you mainly get for free, and barely has any dedicated readership).
Nothing magical happens past day 12 from the first vaccine in the Pfizer paper, or day 18 in this paper. Seriously. Look at it.
Yes, ynetnews is ynet/yediot. Their reporting of covid is exactly parroting the government with no criticism whatsoever so far.
I’m not antivax, I’m provad. 50% is pretty damn good for a first attempt. But everything has become so political, I go read primary data - and it is NOT remotely close to what the headlines say.
Original comment:
I don't know where you're getting this, but the Pfizer paper [0] clearly shows that disease prevalence is much lower after the second dose:
> Among participants with and those without evidence of prior SARS CoV-2 infection, 9 cases of Covid-19 at least 7 days after the second dose were observed among vaccine recipients and 169 among placebo recipients, corresponding to 94.6% vaccine efficacy (95% CI, 89.9 to 97.3).
> Between the first dose and the second dose, 39 cases in the BNT162b2 group and 82 cases in the placebo group were observed, resulting in a vaccine efficacy of 52% (95% CI, 29.5 to 68.4) during this interval and indicating early protection by the vaccine, starting as soon as 12 days after the first dose.
You are right about the severe cases though - they had 1 in the vaccine group and 4 in the placebo group, which is far too little data to draw any meaningful conclusions from (it's also worth noting that the single severe case in the vaccinated group occurred >7 days after the second dose, so there is absolutely no data to draw conclusions on severe disease impact with a single dose).
[0] https://www.nejm.org/doi/full/10.1056/NEJMoa2034577 [1] https://www.nejm.org/na101/home/literatum/publisher/mms/jour...
Indeed, maximum efficiency is achieved after 12 days in Pfizer data (and similarly in the Israeli data). That's the reason some countries consider giving just one - they suspect it won't be as-long-lasting without the booster, but that's from prior experience, not anything specific for this vaccine.
I'm incredibly frustrated at the amount of people parroting "yes, two weeks after the first vaccine it's 50%, two weeks after the 2nd it's 95%". Yes, that's what Pfizer said, and I think I managed to reproduce their calculation - and if I did, it is intentionally misleading.
It seems a lot of people are religiously believing the headlines without looking at the publicly available data. I thank you for looking at it.
What Maccabi did publish on the second dose, it was in a much more encouraging note. Granted, not a peer reviewed paper, that would be difficult given lack of time.
Claiming Yediot is parroting the government is delusional. I won't belabor about it, since most HN readers deserve better than Israeli politics or the eternal elections.
The Maccabi study was designed with this comparison in mind: they look at efficacy in days 1-12 and 13-24 after the first dose. They are mainly interested in comparing the Pfizer results for days 13-21 (89% efficacy) with real-world data. They show that the real world data is actually showing only ~50% protection in days 13-21, compared to 89% in the Pfizer data for the same period. This is somewhat disheartening.
HOWEVER, the Maccabi paper is not measuring the same thing as the Pfizer study. The Pfizer study only looked at symptomatic infections (Covid19 symptoms + positive PCR for SARS-CoV-2), while the Maccabi paper is also including asymptomatic infections.
Neither study includes sufficient data to accurately compare with the other one - the Pfizer study did not do PCR tests on anyone who didn't show symptoms, so we don't know how many asymptomatic infections they had exra; and the Maccabi study didn't record symptom information, so we don't know what percentage of those infected were symptomatic.
All of these numbers and facts are explicitly mentioned in the Maccabi study, it's not me reading into the data on my own.
We always knew that the the Pfizer vaccine has a lower chance of preventing transmissions, the original treatment regime was two doses, and we further know that the Pfizer vaccine wasn't originally tested vs B117 and the other mutations and it's quite possible it has lower efficiency vs those.
Still, there's a good chance two doses offer even higher protection, and frankly if all adult population receives only the 'symptomatic' protection the plague will be over as far as Israel is concerned (barring yearly(?) boosters) - hearing there's any protection for asymptomatic infections is heartening.
The political rather than medical decision making in Israel is out in the open, there’s no need for conspiracies.
It took @RanBalicer 3 days to acknowledge the abysmal data, and it was not “gee, we might have made a mistake in the model”, it’s always “an unexpected twist in the mutation/behaviour/population”. It is beyond embarrassing. But I digress.
Let’s just agree that the 95% RRR for “reported mild symptoms” is meaningless, and that the 50% number from Maccabi is actually good news, and we should use that number in models and predictions?
50% efficacy after the first dose is exactly the number that BioNTech reported in its Phase3 trial. So nothing unusual here. That is why the 2nd booster shot is needed to get to 95%.
Please prove that you actually read the Pfizer report and not just repeating headlines before calling me a lier.
I might have misread some data, but I see no indication that you are in a position to judge that.
Is this an actual spelling in some dialect of English?
It looks interesting. In medicine, when I see “gy” I’m thinking gynolocologist.
I'm more concerned about lack of efficiency than safety. The problem is that after they get one of the vaccines, they won't have any chance to get more from the Pfeizer vaccine when it arrives.
Just as an example Sinovac is not even used in old people in China as far as I know.
There’s a similar question with AstraZeneca right now, German vaccination committee would like to see more Phase 3 data on old people before moving into Phase 4.
On the other hand, they might just wring out the best response possible at a slightly greater risk. Here I'm assuming your parents shouldn't try a PRC vaccine, so it's virus vector Russian or mMRA Pfizer, both essentially accomplishing the same thing, both with high overall efficacy.
Or look at it this way: if they don't get a good result from either of these two vaccines, they're not likely to fair well from a real infection. Maybe. We really don't known why even at their age most people survive.
The other factor is how much you trust quality control. Pfizer > Russia >> PRC in my book, but I have absolutely no read on Russian quality. But also note Pfizer/BioNTech is useless if not properly handled to its strict temp and physical requirements.
Ouch. Reading this from Canada hurts.
(We are way behind EU and I would be very surprised if we get ahead of them at any point).
You don't appear to be behind the EU in any substantial way. (2.61 doses/100 administered for EU, 2.49/100 for Canada)
https://www.bloomberg.com/graphics/covid-vaccine-tracker-glo...
----
You've purchased more vaccine relative to population than basically anyone else in the world and you appear to be higher than the EU in terms of the line for deliveries.
https://www.bloomberg.com/graphics/covid-vaccine-tracker-glo...
It has been an unfolding story for the past couple of weeks. I wish I know of an article which summarized everything with a timeline, but I do not. The gist of it is that, Canada has purchased many vaccines, but they will not be coming soon enough. It also lacks the leverage that US, UK, and EU have in terms of the production being domestic. So when Pfizer ran into production issues, initially they planned to cut Canada's deliveries by ~50% for 4 weeks but EU's by a 8% for 2 weeks. Of course the issue has developed since then, but the central issue remains the same: Canada is not a priority for getting vaccines, and does not have the leverage to make itself the priority. I am deeply concerned that EU would simply block exports to Canada to make up for the shortfalls in its share of the vaccines. Even before the new laws, that was close to what was happening in practice, with deliveries to Canada being affected most and to EU the least.
Also, Canada's not being far behind is because we started earlier. We have seen our vaccine doses administered per capita ranking go from 6th to 21st. Most of the countries that got ahead of us are the EU countries. And every day, we fall behind more and more EU countries, as our deliveries have been deprioritized compared to EU's. Or at least so it seems. We won't know the full truth until the dust settles. Probably a year from now.
This is simply because of different contractual obligations to the different parties. If I owe you $100 by the end of year, but owe someone else $20 by end of month, I'm going to give full priority to repaying the other person.
> I am deeply concerned that EU would simply block exports to Canada to make up for the shortfalls in its share of the vaccines.
Unwarranted: they've explicitly said they won't. Lots of articles on your news source of choice. one random example: https://www.nationalobserver.com/2021/01/28/news/eu-health-o...
As a fellow Canadian, it simply doesn't seem to be a big deal yet. May become one, but whatever.
I am not so sure. Canada was the 4th country to sign a contract with Pfizer. We were ahead of the EU. The initial statements by the Canadian government about the reduction in Pfizer production capacity was that they expect all countries will be affected similarly, but the next day we learned that Canada will be affected an order of magnitude more that Europe. It's unlikely that the government did not know what their contract said when they made those statements. In retrospect, Pfizer probably calculated that pissing off Canada is preferable to pissing off Europe and acted accordingly. Now we see that Canada accepted the slowdown gracefully, but Europe threw its weight and started changing the rules. Politically, they made the most expedient decision. But it was and is unfair to Canada.
I'm just not that concerned about it personally. There'll be a political price to pay if it doesn't work out, as well as a contract violation price for the manufacturers. I don't expect I'll be able to get a vaccine until August at the earliest anyway.
I wish addressing climate change was covered with the same urgency by media (mainstream, niche, social, all of the above)
So if there is a need for a new vaccine, we can likely deploy it with a shorter interval to availability and much larger initial volume.
We can also become more disciplined. We don't need to go all the way to a strictly enforced lock down to improve on the social distancing that we've done the last year (at least, not in the US). And we can try to get people to more widely accept contact tracing/tracking.
I'm saying there's reason to be optimistic that we will be able to respond successfully even if the current vaccines don't end the pandemic (and it likely would be reasonably quick too, our tools are much better now than 12 months ago).
At some level of production capacity, convincing people in high risk areas to social distance and convincing people to get another vaccination are the hard parts.
People don't even want to talk about that, as if those alternatives don't exists. Non-EU countries in Europe are getting them. Serbia(6.1) and Turkey(2.3) are already close to EU average(2.6) or better on the vaccination process.