The state of the vaccines

There's no vaccine being promoted "without lengthy trials" except Gamaleya's Sputinik V vaccine, which got approved by the Russians ahead of phase 3, although now they are starting a phase 3 with 40,000 volunteers, after all.

All the other 8 vaccines currently on phase 3 *are* having the lengthy trials. Again, people need to understand that the rush is NOT in curtailing the trials, which are proceeding with appropriate numbers and appropriate pace. The rush is R&D, funding (including cost sharing that allows companies to plow ahead without fearing bankruptcy if their vaccine fails), production equipment, red tape, preparedness for distribution, etc.

 

Some Pfizer/BioNTech news:

They have enrolled 23,000 people already for their phase 3 trial of their BNT162b2 mRNA vaccine, so, they are getting close, 7,000 to go, and they haven't had any severe adverse reaction yet (unlike Oxford/AstraZeneca). So far, so good for them... but being very prudent in terms of remaining in the race, Pfizer/BioNTech have launched another vaccine, which they called BNT162b3, and are starting phase 1 for this one. This way, if their current one hits a road block like the Oxford/AstraZeneca one did, they have a second one coming right behind it. Smart move.

Pfizer continues to say that they will likely finish their BNT162b2 phase 3 trial by the end of October, thus likely becoming the first vaccine in the world to finish phase 3.

So, fingers crossed, folks. 7,000 subjects more, and if these don't have any severe reaction like the 23,000 haven't had yet, and if they do avoid infection as compared to the placebo group (say, they avoid 150 to 200 infections as compared to placebo) then Pfizer will be in a position favorable to earning regulatory approval, maybe the first one in Western countries to have it.

Russia has already fully approved theirs (ahead of phase 3; imprudent move) and China has granted emergency approval to three of them for special populations - health care workers and the military (also ahead of phase 3 conclusion); and it's not excluded that Sinovac/Butantan Institute's CoronaVac vaccine will finish phase 3 in Brazil and the Philippines about at the same time as the Pfizer one or shortly after that.

The two vaccines most likely to cross the "completed phase 3" line are the Pfizer/BioNTech's BNT162b2, and the Sinovac/Butantan CoronaVac. The latter is stable with minimum refrigeration. The former requires storage at -94 F. So, Even though Pfizer may end up crossing the line of regulatory approval first, Sinovac may cross the distribution line first.

I expect that in December regular people in China and Brazil will start getting the CoronaVac, and in January healthcare workers, and the old and frail will start getting the BNT162b2 in the United States, if neither vaccine bumps into a bad adverse reaction.

 

My uncle had transverse myelitis. The doctors thought he got it as a result of a mosquito borne virus of some sort. He basically woke up one day a paraplegic - no function below the waist. Over time he was able to walk with a cane, but he was never physically the same and took his own life some years later.

I would hate to think that others might be needlessly exposed to something that could have that impact if better alternatives existed.

 

Yes, terrible. I think that if it is confirmed that the Oxford vaccine has caused transverse myelitis, it's the end for them.

 

~ China says it already has a vaccine .

https://www.businessinsider.com/china-giving-coronavirus-vaccine-candidate-key-workers-2020-8

 

Yes. Back to the drawing board.

 

This has been known for a while, already. And it's not one, it's three. Like I said in post #131, "China has granted emergency approval to three of them for special populations". This article of yours is from August 24th, two and a half weeks ago, and it makes reference to a fact known since late July. Interestingly enough, their most promising one, the CoronaVac, was not the three they started using (CanSino, Sinopharm, and the China National Biotech Group). Go figure... the CoronaVAc from Sinovac is the one with the best phase 1 and 2 results but they started giving to their healthcare workers, the military, and border agents, the other ones... I wonder why.

 

Thanks mate! A day I learn something new is never a day wasted

 

Day am! You could always sign up for one of our trials mate - fly into Aus get the shot and I am pretty sure we would come to you in quarantine then fly back to the states without breaching said quarantine. It actually might be a way to get ours field tested in the most meaningful way

 

Two pieces of news:

One: I knew it! It looks like the Russian data on safety and efficacy of their Sputinik V vaccine is fraudulent!!! Peer reviewers found that the article they sent to the Lancet is full of suspicious data, like two sets of 9 and 7 subjects all with identical antibody titres on day 21 and 28 despite having received different strengths of the vaccine. 29 scientists (mostly from Italy but also from the US, Australia, and other European countries, some from very prestigious universities) sent a letter of concern. It's been said that the statistical probability that these same numbers are true and the same for all these different subjects (who again, got different doses/strengths of the vaccine) is pretty much non-existing, showing manipulation of data.

https://cattiviscienziati.com/2020/09/07/note-of-concern/

What wouldn't Putin do? We can't trust data coming from Russia, and this is a reminder that we can't trust China either, so who knows if the CoronaVac is performing as well as advertised? At least the latter apparently had corroboration from the Brazilians who are much more reliable, but still...

I'm getting more hopeful the Novavax, American company, tests in Australia. We will be able to trust the data on that one.

Two: The Chinese started phase 1 tests for a vaccine delivered by nasal spray, which makes it much easier in terms of logistics of distribution and administration. Hopefully this will be good... but again... can we trust the Chinese that data won't be falsified and exported products won't be counterfeit?

 

~ Of course not.

 

Haha, Australia is a tiny bit too far... but thanks for the invite. Cheers.

 

Most United States voters would worry that a Covid-19 vaccine made available this year was rushed through rather than a scientific ... Kamala Harris opted not to say whether she would take a coronavirus vaccine put out by ... though Trump has claimed one could be approved before the November election.

https://www.forbes.com/sites/mattperez/2020/09/06/65-of-us-voters-would-be-skeptical-of-a-covid-19-vaccine-this-year/#471a28562bcb

 

While I'm rather irritated with Trump and have decided, after long consideration, to vote against him in November, I do not like this kind of thing, either, because it undermines people's confidence in a vaccine, when one is finally among us. It is *essential* if we want to beat this virus and restart our economy, that a significant proportion of the American population will accept the vaccine. It is VERY important to help people realize that the rush is NOT in the safety steps. Better proof, a safety concern halted the Oxford/AstraZeneca trial. The animal studies followed by phases 1, 2, and 3 of human trials are proceeding EXACTLY as they should, for ALL current vaccines on phase 3 except for the Gamaleya vaccine from Russia. There's been NO rush in terms of curtailing the size and duration of these human trials. What made the vaccine development much faster than usual was:

1- The concerted effort of a huge number of scientists around the world
2- The fact that governments have engaged in cost sharing and grants, which have allowed developers to proceed faster, without being terrified about going small step by small step, not to invest too much of the company's money on it until every step could be painfully and slowly scrutinized for financial security before the next step. So, with cost sharing, a small start-up like Moderna could jump into pre-production (in case the vaccine succeeded) in order to be ready to distribute day one after regulatory approval, without fearing bankruptcy if they invested all that and the vaccine failed. So, Oxford/AstraZeneca's one may fail... but the company won't suffer, which motivates that one and many others to be bold and forward-thinking and jump head on into R&D and advance production
3- Grants allowed small start-ups like Moderna to hire 100 additional scientists so that they could take turns in night shifts and weekends in order to continue R&D 24/7.
4- Infrastructure, machines, equipment, even glass vials, can be done faster if there is money
5- Planning for distribution is going on in many countries
6- Efforts are made to decrease red tape and expedite reviews of the data

But, the TRIALS THEMSELVES ARE NOT BEING RUSHED OR CURTAILED IN ANY WAY!!!!

Actually some makers are going above and beyond the usual number of subjects in these trials. They are SAFE and APPROPRIATE trials.

Don't trust the Russians... they seem to have faked their data on phase 1 for the Sputinik V vaccine... I'm not sure if we can trust the Chinese either (so far they haven't looked like they are faking stuff and international partners seem to confirm their data, but still...)

But yes, we CAN trust Pfizer/BioNTech, Oxford/AstraZeneca, Moderna/NIH, Novavax, Inovio, etc., to go through appropriate, complete, and well-designed phases 1, 2, and 3 trials.

If a vaccine candidate passes phase 3 with flying colors it WILL be safe, or at least as safe as other vaccines in the past (given that absolute safety can't be known until post-market data comes in, but all vaccines need to start somewhere).

Please, don't undermine the acceptance of vaccines... we need them.

The nine main makers, the FDA, and the NIH all said that they will NOT seek approval of a vaccine if safety trials are not complete.

Sure, Trump wants it sooner... but he won't succeed in this. The eventually approved vaccine or vaccines WILL be safe. Pretending otherwise is doing a disservice to public health.

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Yes, I understand that this cartoon is funny, and yes, I do have a sense of humor, but I don't think this pandemic is a laughing matter. As a healthcare worker, my main concern is public health, and this kind of thing is dangerous.

Without a vaccine a lot of MORE people will die or get maimed, and the economy will take a lot longer to recover.

Yes, we want the vaccine to be safe. But if it *is* shown to be safe, than we need to accept it, as numerous as possible.

 

Just a few minutes ago I was on the phone with a colleague from abroad. I can't give details as it is confidential, but the colleague (who is very reliable, ethical, competent, and is directly involved with the phase 3 trial) said that the portion of the phase 3 that is being done in his country for the CoronaVac vaccine does seem to confirm the Chinese data; no serious reaction has been seen, and immunogenicity has been excellent both in young/healthy people, and in elderly/less healthy people. He believes that this vaccine is a winner and that it will earn regulatory approval.

I'm always suspicious of Chinese data but this non-Chinese colleague does know what he is saying, and I trust him.

Fingers crossed, although it is not likely that this vaccine will help us here in the United States anytime soon, given the tensions between our country and China. But it's good to know that it seems like it *is* possible to develop a highly efficacious and save vaccine against the SARS-CoV-2.

 

Excellent news, my friends (or maybe not so excellent if safety is being a bit disregarded): the Oxford/AstraZeneca trials have been authorized to resume, by the British independent committee that looked into the two (like I said, by now confirmed to be two, not one) cases of neurological adverse reactions. Wow, record speed for a Safety Board review! I was expecting at least a couple of weeks if not longer.

It puzzles me because I think it's a hard-to-believe coincidence if these two cases are unrelated to the vaccine, but hey, I wasn't there to look into the evidence, and maybe there was a clear source for the problem that was indeed unrelated to the vaccine (I've mentioned the multiple possible causes of a case of transverse myelitis - post #128 above - and the first case, it's now been leaked that it was multiple sclerosis, more likely to be there before the vaccine was given; it would be harder to believe, given incidence, if both cases were transverse myelitis given its rarity, but the much more common MS not being related is more believable, and if it was only one case of TM, maybe indeed it was a coincidence).

They aren't releasing more details, according to them, out of respect for patient confidentiality (which again puzzles me because they could have said more without revealing any patient-identifying information), so I guess we'll have to take their word for it.

Now it's up to the other regulatory agencies to decide if their trials will resume too, in the US, Brazil, South Africa and elsewhere. The trials have been authorized to resume in the UK. We've learned that 18,000 people have been given the Oxford vaccine in trials (I thought they had a bit more than that, but fine).

From my friends abroad, I just got another phone call (I've been in constant touch with them) saying that out of 5,000 cases they managed in their local branch of the phase 3 trials for Oxford/AstraZeneca, nobody had a serious reaction. That's not enough to establish safety but it is good to know. So, up we go again, and Oxford/AstraZeneca, contrary to my concerns, are back in the game.

Meanwhile, Pfizer/BioNTech are making the very commendable spontaneous move of increasing the size of their Phase 3 trial to 44,000 subjects. I think Pfizer is trying to play the long game and enhance public confidence in their vaccine, and that's a good move. I always suspected that with their huge infrastructure and long experience and expertise, Pfizer would end up winning the vaccine race or at least being one of the winners (the Chinese CoronaVac remains strong).

 

I find it strange that this thread doesn't have a lot of traffic... are people not interested in a vaccine? I think vaccines are the most important, most hopeful way to beat this virus.

Anyway, here is a VERY long (I didn't have the patience to read it all) but quite interesting article about the backstage operations in the race to get a vaccine, including snapshots of White House meetings.

https://www.usatoday.com/in-depth/n...imeline-companies-progress-phases/3399557001/

 

If you have wandered through some of the other threads you will have noticed that a lot of our posters come here to spew propaganda/conspiracy theories and shout at other people. This thread is heavily laden with detailed, expert information and is not well suited to stupid arguments ans ill informed opinions.

Personally I'm happy enough for folk to leave this place for information drops and informed comment/question. Bit of a unicorn thread this.

 

Pfizer is confident that they will have efficacy and safety data by the end of October and will deliver the vaccine to the US by the end of December, if it earns regulatory approval. They are already producing the vaccine, just in case (which is one of the items I addressed above, about the rush being in other phases of the R&D to consumer, not in the safety and efficacy checks which are proceeding in standard manner).

https://www.marketwatch.com/story/p...in-us-by-end-of-year-2020-09-13?mod=home-page

 

I can see how the tone of addressing the scientific side of vaccines and how the race is developing, is not exactly conducive of a lot of political arguments although I've noticed that some posters have tried. I have only a partial view of this because by now I have a number of rude trolls and conspiracy theorists on Ignore.

I can imagine that certain good news about vaccines don't interest some political operatives. Maybe some people want the vaccines to fail or at least to be delayed well past the elections, not to have a huge impact on public opinion. Also, I'm sure that anti-vaxxers don't want to hear good news.

I'm also very convinced that some vested interests don't want the United States to get out of this pandemic through a very safe and very efficacious, widely distributed and accepted vaccine. There is objective evidence of this: a member here (whom I've placed on Ignore) has posted a Russian source that attempts to discredit some of the Western vaccines, even suggesting that they can cause cancer and infertility. They also say that the Westerners are rushing a vaccine... which is ridiculous because they approved theirs after 28 days of testing in 38 subjects... while ours are being tested over several months, with 30,000 to 44,000 subjects...

So they are starting their massive vaccination campaign... apparently FOR THEM vaccines are good... while at the same time they are trying to suggest in Russian web sites published in English, for the consumption of Americans and other Westerners, that our vaccines cause cancer and infertility... I'm sure that Russians will be delighted if they come out of their contagion with vaccines while the Westerner countries continue to struggle, in case they can sow enough misinformation to have an impact on the acceptance of a vaccine among us. That would give them an economic advantage. So I wouldn't believe in anything that the Russians say... either about the alleged efficacy and safety of their vaccine, or about the supposed lack thereof of our vaccines.

 

Some of them will always try, but generally they scuttle off to troll elsewhere once it becomes clear that they are making fools of themselves.

You must have a large and rapidly expanding ignore list.

Most of the hard core political operatives will just echo the relevant political imperative. The human consequences aren't really front of mind. As for anti-vaxxers, I pity those who are suffering from mental illness that profound, but pity doesn't compel me to pay attention to their opinions.

If you assume that anyone who cites Russian media or admires Putin is a pro-Moscow troll or a moron you will be right better than 95% of the time. We have a serious Putinist infestation here. They will parrot Moscow propaganda at every opportunity and insist it is the absolute truth. You have correctly assessed the nature & purpose of the propaganda - concern for human life doesn't enter into it. Your scientifically based doubts over their vaccine won't get you anything but more propaganda or abuse.

Again, your ignore list will be getting a workout.

After all that I should add my thanks for your forbearance. You have consistently provided not only good quality information, detail and, when required, well laid out argument. For those of us with a genuine interest but no medical training or access to that level of information it has been invaluable.

 

Congratulations on using your first post on this thread to prove my point about the sort of people who do & don't contibute to this thread. At least the quality of your contributions is consistent.

 

Oxford/AstraZeneca trials have resumed in Brazil too, in addition to the UK.

 

What I like about BioNtech and Pfizer their refusal to take government money, no strings attached.

Those glass vials, there is a German company, which basically has a monopoly in Europe, they will make a killing.
The race for a vaccine is just one side of the problem, vials, boxes, syringes, needles and than distribution is the other side.
Curevac is spending so much money already on the production side, that Elon Musk went to Germany to have look. One of his Tesla subsidiary in Germany is building the bio reactors.
The moneys involved, world wide, is mind boggling

 

I think there may be many, like me, who are informed enough to realise we have nothing to contribute to this thread but who are none the less very interested in a vaccine.
Keep up the good work.