The state of the vaccines

I was just thinking how excited we would have been 3 months ago if we had a therapeutic with such results.

 

New research by my colleague Michel Nussenzweig of the Rockefeller University found that both the Moderna and the Pfizer vaccines are highly likely to be effective against both new variants, the B.1.1.7 (British) and the B.1.135 (South African), contrary to other concerning findings by other groups. This is such a relief!!!

 

The Moderna vaccine seems to cause fewer anaphylactic reactions than the Pfizer vaccine.
Pfizer, 21 in a sample of 1.8 million, that's 1 in 85,714
Moderna: 10 in a sample of 4 million, that's 1 in 400,000
Paradoxically the Moderna vaccine seems to cause more non-allergic side effects.
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By the way, my 2nd dose of the Pfizer vaccine, now given 36 hours ago, caused a sore site of inoculation, some muscle pain, some joint pain, mild fatigue, a tiny headache and a temp of 99. By now all symptoms are gone and my temp is back to 96.5. I was able to work all day today. My wife's second dose - also Pfizer - caused much more pronounced side effects. She felt generalized muscle and joint aches, more severe headache, nausea, was very fatigued and sleepy, with general malaise and dizziness. She went to work this morning at 8 but couldn't get through her day; came home at 12 noon and slept the whole afternoon. She never measured her temperature but thinks she had a fever. She woke up now, 36 hours after her second dose as well, hungry and feeling refreshed and with no other symptoms. A colleague of ours who got the Moderna was knocked out for two full days. Anyway, small price to pay for being immune.

 

Excellent and cute drawings explained the DNA Non-replicating Adenovirus-vector Covid-19 vaccine made by Johnson and Johnson. The page also contains links to very useful graphs about the pandemic.

https://www.nytimes.com/interactive/2020/health/johnson-johnson-covid-19-vaccine.html

 

Merck's two vaccines (one of them with the Pasteur Institute) have failed and were withdrawn. They will not continue to work on a Covid-19 vaccine. They quoted disappointing immunogenicity for the V590 and the V591.

 

The news has come out that, evidently, as in general circulation now, the Moderna vaccine is not effective against the powerful, rapidly-spread new strains of the virus in Brazil and South Africa.

Moderna is now working on a 'booster' shot that I presume would be given in addition to the two shots in the 'vaccine'...(?) Will this also be the case with the Pfizer vaccine, and possibly the other vaccines produced in other countries, by Russia, et al, or does anybody know yet?

This stuff changes nearly every other day, it seems. Does anyone know if the J & J vaccine which is now in Stage 3 trials (and which reportedly will require only one shot) will also have to be supplemented with a 'booster', too? It makes you nuts to try to keep up with all this.

Although we're eligible for the vaccine(s) now, we're waiting for those 'in the know' to arrive at a determination about what's what.... The information posted here by @CenterField is the most up-to-date and reliable that I know of, honestly.

 

I'm not aware of the vaccines being entirely ineffective against the South African and much less the Brazilian strains. Beware of alarmist lay press. Both the Moderna and the Pfizer vaccine appear to be effective against the South African strain although less so than against the previous dominant strain, but still plenty. I do not know of anything being already concluded about the Brazilian strain. If you have anything different, please post links.

Both Moderna and Pfizer have started working on booster shots for the South African strain, just in case. These would be given 6 months to one year after the second dose.

J&J hasn't even concluded their phase 3 trial yet (expected at some point this week) so much less, knowing if their vaccine retains neutralizing effect over the South African and Brazilian strains.

Both the Moderna and the Pfizer vaccines are highly effective against the British strain.

The South African strain hasn't been found in the US yet. The Brazilian one has.

This said, I haven't checked any of my sources today; too busy. As of yesterday I think the above was current.

 

Thank you, as always, @CenterField . I trust your statements about the virus and the vaccines more than I do anyone else's frankly. You've never been wrong, or even "kinda-wrong" like a number of others in the healthcare sector have been, over and over....

 

Interesting article about the mess the Chinese government made of their vaccines, which is a pity. Another example of how politicians screw everything up, damaging the good work done by scientists.

https://www.yahoo.com/news/china-wanted-show-off-vaccines-195223627.html

So, the issue is, Pfizer and Moderna did set the bar very high with their 95% efficacy. But the CoronaVac is not bad at all! It's a question of how to look at it.

So, it had efficacy around 70% to 91% in Indonesian and Turkish trials (which matches a vaccine like AstraZeneca's). In Brazil it was only 50.4% but that's in great part because the trial in Brazil used exclusively healthcare providers who work directly with Covid-19 patients and are constantly exposed to huge viral loads.

Now get this: even in this highly exposed population, the CoronaVac had a 78% efficacy in avoiding moderate cases of Covid-19... and 100% efficacy in avoiding severe cases that needed hospitalization and/or resulted in death.

So, you get a severely exposed population, made only of healthcare professionals tackling the second worst outbreak in the world (only smaller than the United States'), and this, in developing country conditions of over-crowded hospitals with fatigued and poorly equipped staff... and NOBODY in this population who got the CoronaVac developed a severe case of Covid-19, NOBODY needed to be hospitalized, and NOBODY died, only 22% had moderate disease, and all the others either had very mild disease or asymptomatic infection or no infection at all... and this vaccine is being mocked as a failure???

If Pfizer and Moderna hadn't set the bar so high, the CoronaVac would have been considered to be an astounding success!!!

Think of it, if say, in late April in the middle of the first surge, someone came up and said "Hear hear folks, I have this vaccine here. It avoids infection in 70% to 91% of regular folks... and get this, even for the most exposed people of them all, doctors and nurses directly working with Covid-19 patients, it avoids infection in 50% of them, the next 28% of them have at worst mild if not asymptomatic infections, and the final 22% have at worst moderate disease that won't require hospitalization and won't kill them... that is, NOBODY who takes this vaccine will need to be hospitalized or will die of Covid-19 even when faced with a huge viral load... how about that? Who wants it?

People would be celebrating this result wildly and would be running to get it and fighting each other to be first ones to get it.

And the vaccine is cheap, extremely safe (to date practically no severe reactions have happened with the CoronaVac), can be kept at regular fridge temperatures, and its technology can be easily transferred to developing countries so that they manufacture it on site...

Look, in my book the CoronaVac is nothing short of a great success and quite important for the Third World. Sure, we fancy pants people here in the First World will rather have the Pfizer (the one I got) and the Moderna, and that's fine; we are lucky to be First World citizens in more ways than this one. Given the choice, of course I'd rather have the Pfizer or the Moderna...

But the CoronaVac is still excellent and very helpful to the Third World. So, instead of marketing the vaccine like this, the Chinese politicians had to initially try to hide the 50.4% efficacy, trying to merge the Brazilian results (which are highly reliable and provided by a very ethical and competent group at Instituto Butantan) with the Turkish and Indonesian ones - ultimately the Brazilians refused because these trials were heterogeneous in the kind of populations they targeted, and the information from the other two countries was not as reliable, so the Brazilians ended up releasing their own data independently. Then instead of simply touting the fact that even if the CoronaVac only avoids completely the infection at a 50% rate in the most exposed populations, it does protect against hospitalization and death at a 100% rate, the Chinese had to try to spread misinformation about the Western vaccines, smearing them with false claims...

So now, NOT thanks to the scientists, but thanks to the politicians, everybody is suspicious of the CoronaVac. Bravo, politicians. You got in the way again, and screwed up, as usual.

 

Preliminary Novavax results for their protein subunit vaccine: 89.3% efficacy in the UK's B.1.1.7-dominated environment but only 49.4% in South Africa's B.1.135-dominated environment.

https://ir.novavax.com/news-release...-vaccine-demonstrates-893-efficacy-uk-phase-3

This is the first indication that indeed the vaccines work much worse for the South African variant. Novavax has already started working on a new vaccine that would also hit this variant.

And the South African variant has been found in South Carolina today, two cases, geographically distant, and they haven't traveled, so, it's already in the community.

These are very bad news.

This result comes from a very small number of cases so the 95% confidence interval varies from 6% efficacy to 73%. So, still preliminary.

But this is not good.

 

Thank you VERY much for staying right on top of this, @CenterField!

It's interesting to consider 'who-knows-what'. Today I told a friend of mine in Germany about the Johnson & Johnson vaccine that is in 'stage 3' trials over here, and although my friend stays very up-to-date with all the 'virus' news, he had heard NOTHING about the J&J vaccine at all. Nevertheless, in Europe, people are getting quite spun-up about this whole thing.

I hope that in the 'stage 3' trials for the J&J vaccine that the testers are taking the new virus mutations into account....

 

Yes, given that the ENSEMBLE phase 3 trial by Johnson and Johnson has South Africa as one of the sites, we may get some sub-set of data that will shed some light into the efficacy of the vaccine for the South African variant of concern. It will be a smaller sub-set, though. Their trial is being done in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States. Results are coming early next week.

I'm surprised that your friend doesn't know about the J&J trial. See if your friend knows about the Janssen trial. It's the same one but Europeans may know the company better by its European Janssen division. Everybody is excited about the J&J (a.k.a. Janssen) vaccine because it is a one-shot vaccine, unlike all the others that require two shots. It is also a bit different than the others. It uses DNA inside a non-replicating viral vector, therefore the genetic material is very well protected and then, doesn't need to be kept in freezer temperatures.

 

J&J data are in. I'm a bit disappointed.

Overall, J&J's study found the shot to be 72% effective in the US, 66% effective in Latin America, and 57% effective in South Africa. So, that's another vaccine with markedly diminished effect against the South African B.1.351 strain.

J&J said its vaccine was 85% effective across all regions at preventing severe cases of COVID-19. This is also far inferior to some others that reach up to 100% at preventing severe cases.

Oh well, at least the vaccine did make the 50% threshold, and the safety record is good, so it did make the minimum requirements for FDA approval, and they will file for approval soon. In about 3-4 weeks we should have the J&J shot, added to the Pfizer and Moderna ones.

But the result is not brilliant. One wonders what it would have been, if they also did a 2-doses regimen. I guess if someone can't have the Pfizer or the Moderna, getting the J&J is better than nothing...

 

Today Mrs. Hays and I received our Pfizer first dose shots. Second dose 20 February. It is worth pausing to give thanks for the massive effort that produced this result.

 

J&J is not extraordinary, anyway it's more effective to protect from heavy forms of the disease. And in any case it as effective as a common anti flu vaccine.

Also about Astrazeneca there are problems: Italian drugs authorities are suggesting its usage only for persons between 18 and 55.
It seems that it's not so effective for older individuals. Furthermore Astrazeneca vaccine seems to be less effective than Pfeizer BionTech and Moderna.

So now for Italian general population we've got Pfeizer BionTech, Moderna and Astrazeneca; for persons above 55 only Pfeizer BionTech and Moderna.

 

As an aside note, I would underline what Alert Bourla [Pfeizer CEO] has said: vaccines could become ineffective in a not far future.
https://www.businessinsider.com/pfi...vid-19-vaccines-wont-be-effective-2021-1?IR=T

This is useful to underline that we are navigating through a not so known sea on a side [new vaccine tech], but through known waters [how virus like SARS-Cov-2 can mutate quickly, like the flu virus].

So, it's important to vaccinate a large part of the population in a not too long time, but it's also important to develop the technologies to be ready to produce an upgrade of the existing vaccines in some months [the CEO mentions the notorious 100 days].

 

Is it because it is less effective for older individuals, or merely because of a lack of data? I haven't followed the AstraZeneca data so closely, but if I'm not mistaken, the issue was that their phase 3 trial didn't have enough elderly subjects. So, given that it is inconclusive, and given that Pfizer and Moderna did include them (with good results) it is wise to prefer the Pfizer and Moderna for the elderly. But it doesn't necessarily mean that the AstraZeneca is ineffective for them; maybe with more data it will be shown that it is.

It is true that the AstraZeneca seems to be overall less effective to avoid infection; however it is effective against severe disease and deaths, so I think it is a valuable tool and I lament the fact that it hasn't been approved, this side of the pond.

Now, about J&J, I wonder if it was hindered by its decision to go for 1 shot. If you think of it, its efficacy is significant when you think that it is achieved with 1 shot. I wonder if it wouldn't be just as good as the Pfizer and Moderna, with 2 shots. Also, the J&J was tested against two new variants, the B.1.1.7 and the B.1.351, while the Pfizer and Moderna were only tested against the previous and less aggressive variants. So I wonder, if we were to repeat the Pfizer and Moderna phase 3 trials using the same population used for the J&J trial (especially, including South Africa), if the two wouldn't be comparable in efficacy to the J&J. The Moderna and Pfizer trials happened in a time when the new variants hadn't emerged. J&J, lagging behind, was unlucky in the fact that they were tested against harsher variants.

[I hold no J&J stock... just saying.]

 

Here we have to become technical.
You know that some vaccines increase their efficiency with a second shot. Not only this [I'm not going to say which one], a vaccine seems to work better with 1/2 shot plus 1 shot.

But these vaccines are the ones which require an extreme cold chain.

We know why a flu vaccine records an efficiency only a bit above 60%. We know how flu vaccines have produced.
You analyze the ongoing flu pandemics. Ok. You collect information about the flu variants ... during Spring the flu migrates to the Southern hemisphere where it will mutate ... researchers simply "guess" which will be the most important variants to come back next season and they pass this information to the producers of the vaccines.

But in the case of Covid-19 we do know SARS-Cov-2, so that, at least in the brief term, researchers haven't to guess. This is why the best vaccines against Covid-19 can record and efficiency above 90%.

And this brings us back to the CEO of Pfeizer: he's right ... Covid-19 could develop into "Covid-21" which could be so different to make vaccines ineffective.

Personally I hope in an other species jump [with a return to the human species].
But it's still early to think about this.

 

True. The Oxford/AstraZeneca vaccine had this weird fluke of the half dose/full dose with 90% efficacy. And yes, the Oxford/AstraZeneca and the Janssen (J&J) do not require freezing temperatures for their cold chain, which is a great distribution advantage especially in less developed countries and rural areas of more developed countries.

The analogy with the flu shot is great. If a vaccine, while not being as efficacious as the Pfizer and Moderna ones to avoid infection, still avoids severe disease, hospitalization, and death, that vaccine is a great asset.

Covid-21 is indeed not impossible... unfortunately. This possibility scares the hell out of me.

 

Important:

Even the "less effective" vaccines as compared to Pfizer and Moderna are still highly effective to prevent hospitalization and death.

On that, all five of the vaccines — from Pfizer, Moderna, AstraZeneca, Novavax and Johnson & Johnson — look extremely good. Of the roughly 75,000 people who have received one of the five in a research trial, not a single person has died from Covid (including in the South African trials with the new and scarier variant), and only a few people appear to have been hospitalized. None have remained hospitalized 28 days after receiving a shot.

To put that in perspective, it helps to think about what Covid has done so far to a representative group of 75,000 American adults: It has killed roughly 150 of them and sent several hundred more to the hospital. The vaccines reduce those numbers to zero and nearly zero, based on the research trials.

Zero isn’t even the most relevant benchmark. A typical U.S. flu season kills between five and 15 out of every 75,000 adults and hospitalizes more than 100 of them.

These vaccines make of Covid-19 a disease milder than the flu. That's good enough for me.

 

Surprise: Lancet article today, finally the phase 3 trial for the Sputnik-V, and this time, it seems like they did publish credible data, endorsed by independent commentators. Their vaccine appears to have an efficacy rate of 91.6%, with a sizable study this time, involving 14,900 subjects in the active arm.

Despite the bold approval ahead of data, and the controversial first publications, it seems like their gambit paid off and their vaccine is actually very good.

So, now the world has another valid tool. The Sputinik-V is in use in Russia, Argentina, Algeria, and other countries.

Here are the countries that have received stocks of the Sputinik-V although it hasn't been approved in all of them yet (some countries got it in anticipation of approval):

Algeria
Argentina
Belarus
Bolivia
Brazil
Egypt
Hungary
India
Kazakhstan
Mexico
Nepal
Palestine

In addition to these 12 countries that have received shipments, 38 others are placing orders.

Here are the countries that have approved it:

Algeria, Argentina, Armenia, Belarus, Bolivia, Guinea, Hungary, Palestine, Paraguay, Russia, Serbia, Tunisia, Turkmenistan, United Arab Emirates, and Venezuela.

These four countries are equipped to, and willing to make the Sputinik-V on site and add to international sales: Brazil, China, India, South Korea.

It seems like, after all, the Sputinik-V is turning into a huge success story!

I confess that I'm surprised. But I said in the very beginning of this thread that it was possible that Putin's bet would pay off. Seems like it did.

 

Two interesting new facts: the AstraZeneca shot conserves protection with one dose of 76%, until 12 weeks, and delaying the second dose actually increases protection; so it seems like the British strategy of spacing out first and second dose was correct after all.

People who have had Covid-19 before develop antibodies 10x more with one vaccine shot, so they may need just one as a booster instead of two shots.

 

Another strain has been found in the UK similar to the South African strain and similar to the one now referred to in the UK as the Kent strain. This virus is mutating much faster than initially thought it would. This new mutation is on the spike which is a concern.

 

Yes, I posted about it in my thread about the variants.

 

All in all in all... knowing only what our understanding of vaccines has been refreshed with as of today, 2 Feb 2021, I'm going to opt for the Johnson & Johnson vaccine, even though it isn't even 'out here' in the world yet....

It's ONE shot, and it doesn't require transportation and storage using almost unbelievably deep, DEEPLY-frozen temperatures to keep it from getting 'going bad'.

The J&J vaccine is a bit less 'effective', they say, than the ones put out by Pfizer and Moderna -- but, it is, nevertheless, VERY effective against the worst-case kinds of infections which put you in the HOSPITAL, or, which can KILL you.

So when will the J&J vaccine be available throughout the United States? They haven't gotten around to telling us that yet....