The state of the vaccines

Agreed. Vaccines are coming but will take a few months to reach everybody who wants one. Meanwhile people should remain prudent and wear masks, eye protection, and engage in social distancing and hand washing.

 

I saw a video explaining the Moderna mRNA vaccine and they mentioned at around 12 in the video some “Manufacturing at Risk” millions of doses and then dumping them if they fail the approval.



Most likely, just cover doctors…taking all the risks. Have to wait and see.

 

Yes, that's what I've been saying. That's the cost sharing built into the Warp Speed initiative. It allows a small company like Moderna to start manufacturing before approval, because if it's not approved and they have to dump the vials, they won't go bankrupt. This has nothing to do with covering up risks. The "Risk" being referred to here is the financial risk of investing in manufacturing before approval. This financial risk was taken care of, by a federal cost-sharing grant.

 

Another paused trial due to an adverse event (still unspecified), this time J&J's vaccine (AstraZeneca's remain paused in the US).

https://www.statnews.com/2020/10/12...ed-due-to-unexplained-illness-in-participant/

 

bioNtech has started the approval process in the EU.
Its partner Pfizer is expected to request the start of approval process in the US by end of October.
The bioNtech mRNA vaccine phase 3 has run as of today without a hitch.
bioNtech got a nonrefundable grand of 340 million Euro from Germany and is buying from a Suize pharma company a factory in Marburg and will be able to produce 750 million doses in 2021.

 

Funding allows researchers to uncover the secrets of COVID-19 immunity
https://www.uq.edu.au/news/article/...earchers-uncover-secrets-of-covid-19-immunity

You’re welcome

 

Good news. After 10 months it’s good somebody is interested enough to do comprehensive research in this area. Sounds like in two years we may have the answers.

All joking aside, this is interesting. Hopefully a lot is learned.

 

The Russians are pushing the gas pedal everywhere, in their sphere of influence.

The Gamaleya Institute, the makers of the Sputinik V, the first vaccine in the world that got approval from a national regulatory agency (their own, haha), has announced that they will make 1.2 billion doses. BRICS countries will help with production, with India, China, and Brazil making the Sputnik V too (as well as South Korea, not a BRICS member). The Brazilian operation was granted to União Química Farmacêutica National SA, a local private pharmaceutical company with 80 years of experience. They have 7 factories in Brazil, and they will be making the Sputinik V and selling it in the local market, both to governmental and private entities, and will be selling to all of Latin America (they say the price of each dose will be "reasonable and affordable." They are hopeful that the first doses will be distributed to the population in January.

Meanwhile, the proposed date of December 15 to start vaccination with the CoronaVac, the Chinese/Brazilian vaccine from Sinovac and Instituto Butantan, got postponed; they are adding an additional 4,000 volunteers (on top of the previous 9,000) who are healthcare workers directly taking care of Covid-19 patients, to get a better chance of finding cases among the ones who are given the placebo versus protection for the ones getting the active vaccine. By now the Brazilians are utterly convinced that the vaccine is safe as side effects have been minimal not only in the Brazilian trials but also the more numerous Chinese trials, but they aren't yet at the threshold point to be able to detect efficacy, so ANVISA (their FDA) is not willing to approve it yet, so now they find the December 15 date to be unrealistic. They did not mention another date in the future, just said it will be at some point in early 2021.

Currently in Brazil, phase 3 trials are ongoing for 4 vaccines: AstraZeneca/Oxford/Fiocruz with 10,000 subjects, Sinovac/Butantan with 13,000, Pfizer/BioNTech with 2,000, and Johnson & Johnson (Janssen-Cilag) with 7,600. ANVISA will consider data from abroad for these vaccines to reach the desired 30,000 subjects in phase 3, but does want local testing too, which is proceeding as above. However the proponents of the Russian vaccine are arguing that they don't need local testing because of the sheer number of Russian subjects taking it. As the first one to be approved by a government, the Sputinik V will end up being given to millions by year end instead of 30,000-50,000 phase 3 volunteers, offering a much better safety snapshot, so the Russian and Brazilian businessmen are arguing their case with ANVISA, saying that they should get direct approval. The State of Bahia, one of the Brazilian states, has directly purchased 50 million doses from the Russians, and the State of Paraná is also in negotiation with them.

When Putin first announced that they were approving the Sputinik V - after having tested it in only 46 subjects - I anticipated that this would happen: that they would jump ahead of other makers, by simply giving it to millions of Russians and claiming that this is much better for the buyer's piece of mind than data from phase 3 trials with 30,000. It's interesting to see that I was right and they are already making their case like this. (Well, that would be true if we could trust data coming from Russia, which of course we can't).

The State of São Paulo, the owners of the Instituto Butantan that will produce the CoronaVac on site, has established that they will vaccinate all inhabitants (46 million) in mandatory bases. The federal government of Brazil, lead by Trump copycat president Jair Bolsonaro, said that they don't agree with mandatory vaccination, but the governor sustains that in his state, he has the authority to implement it. The feds did agree with purchasing 46 million doses of the CoronaVac directly from China, adding to the 100 million doses they have already ordered from AstraZeneca; both orders are contingent to ANVISA approving the CoronaVac and the Oxford/AstraZeneca vaccine. With those 146 million doses they hope to start vaccinating the people from other states, given that São Paulo will first vaccinate all their residents before they start distributing the vaccine to other states. Given that the CoronaVac and the Oxford/AstraZeneca are given in two doses, 73 million Brazilians from other states will get it, plus 46 million in São Paulo, plus 25 million in Bahia who will be getting the Sputinik V (also needs two doses).

So the current plans will vaccinate 144 million Brazilians, about two thirds of the country's population. Once this first phase is done, all three companies, the União Química, the Fiocruz, and the Butantan will continue to domestically produce, respectively, the Sputnik V, the Oxford/AstraZeneca, and the CoronaVac.

Sounds like Brazil has a Warp Speed that is speedier than the one we got here.

 

Rejoice, my American friends. We do NOT have the stupidest president on Earth in terms of managing the coronavirus pandemic.

President Jair Bolsonaro of Brazil, received in his Tweeter account a message from a 17-year-old Brazilian, asking his president to refrain from acquiring the "Chinese vaccine" because Brazilians would be guinea pigs.

Brazil's Ministry of Health had placed just the day before, an order for 46 million doses of the CoronaVac directly from China, yesterday, in anticipation of the domestic production (this vaccine has been licensed for local production, too). Well, reacting to the infinite wisdom of this 17-year-old child, Bolsonaro cancelled the order!!!

This, despite the fact that the CoronaVac is a joint effort of China AND Brazil, with the Brazilian partner being the world famous Instituto Butantan, a venerable, century-old, high quality biological institute that is the biggest vaccine make in South America and possesses extremely well-trained scientists, and is entirely reliable (sure, I also do doubt scientific data coming from China at times, but I do not doubt data coming from the Butantan).

I've personally worked with the Butantan scientists in a collaboration mission there a few years ago; I've been in touch with them, and from what they told me, it does seem like the CoronaVac is the most effective and safest vaccine to date... The scientists are thrilled with the preliminary results of their phase 3 trial, and eager to finish up and have it approved by the ANVISA (the FDA equivalent, there) in order to start the vaccination, which they planned initially for December 15th but then said it should happen at some point early in 2021. The director of the Butantan (someone I know personally) had traveled to the capital city to speak of the head of ANVISA, and the agency was impressed with the data, and promising to issue an emergency authorization as soon as possible, once the last pieces of data got collected.

So, that country has had 155,000 Covid-19 deaths, probably a gross undercount since when the pandemic hit them, they had a ridiculous low number of test kits so maybe twice this number is more likely to represent the real total of Brazilian deaths, given their shaky healthcare system and many urban areas featuring people living in poverty in crowded small quarters who were dying like flies, undiagnosed.

And the president there has stopped the purchase of what looks more and more like a safe and effective vaccine!!!

This follows the fact that their Congress passed a bill to distribute facemasks free of charge to the disadvantaged Brazilians who couldn't afford them... and it was vetoed by the president!

What a full-blown idiot!!!

 

You are so nice to the President, full blown idiot, that is a compliment.

But always look at the bright side, it will clean out the slums, social problem solved, the Natives, too, they are a pain, those Amazon people and their darn forest.

 

A volunteer for the AstraZeneca trial has died in Brazil of complications of Covid-19. 28 years old medical doctor, recent graduate. Shame. The family has disclosed to a journalistic source that he took the placebo. While the company is not saying due to confidentiality agreements, it seems like it's the case because the investigation rapidly concluded that the trial should continue. The deceased's name was Dr. João Pedro Rodrigues Feitosa.

 

When I read the story I was very worried that he died of complication from the vaccine. But than the story, was up-dated.
Sad for the young man and very sad for his family, what a loss of live, just 29, a Dr. what could his live could have been.
60 years wiped away.

 

Yes, terrible. And so young, and then people here keep minimizing the danger of this virus and keep saying that it's just for the old geezers to worry about.

 

Darn am I lucky, I aint a old geezer, just a geezer.

 

"Oxford coronavirus vaccine works 'perfectly' and builds 'strong immunity to virus, researchers find - providing hope to millions and quelling fears that it might only lessen the severity of infections"

https://www.dailymail.co.uk/news/ar...fectly-safely-triggering-immune-response.html

 

AstraZeneca and Johnson & Johnson have been both authorized to resume the US phase 3 trials. Good news.

 

Say, the CoronaVac ends up being the best and safest vaccine (many insiders are thinking so now, and likely the Novavax one will be second best). It won't ever come to us, at least not under Trump, given that I doubt the current administration would endorse a Chinese solution. As a matter of fact it is already available for $300 in private clinics in China. So medical tourism would be possible to go get it.

Could a wealthy foreign tourist go there to get it? Certainly but I wouldn't necessarily trust a private clinic in Shanghai. The product might be counterfeit, just to get money from the rich tourist. On the other hand it will be also made in Brazil and they are more reliable.

But depending on what happens to our vaccines (say, they become a total failure and the pandemic continues to rage and worsen), how much would cost to chart an executive jet to take a family of four to Brazil to get the CoronaVac, bypassing the risks of commercial flight (even in first or business class, passengers would still share small bathrooms with strangers that could leave an aerosol cloud behind, and even with dedicated check-in and lounges, commercial flight still involves being close to many strangers)?

Say four families (four siblings/cousins, for example, and their spouses and children) get together and chart an executive jet with space for 16 passengers. This would cost each way about $105,000 to $120,000 from New York to São Paulo. So $210,000 to $240,000 divided by 16 times four, this little trip to get the vaccine would cost about $52,500 to $60,000 per family just for the air travel part. Not to forget, they'd have to stay in Brazil for some 16 days given that the vaccine is given in two doses, 2 weeks apart. So, 4 people paying for secure lodging, food and drinks, internal travel (safer would be rental car not to have to deal with drivers in a small car cabin; also safer would be to rent a house rather than staying in hotels, but in order to avoid being sitting ducks - 16 wealthy Yankees in a large house for 16 days might become easy targets for the bad guys - they might even need to hire a good security firm to keep them safe). All things considered this little adventure would cost some $80,000 or $20,000 per person.

Haha, quite crazy. Definitely pocket change for the top 1%, though.

If our mRNA and adenovirus vaccines fail, we should better root for the more promising Novavax one, to make this slightly expensive trip unnecessary, LOL.

If you were a person with very high risk, would you pay $20,000 for the best vaccine? Sounds like a crazy thing to do. But I bet some people will do just that.

 

How are the phase 3 trials proceeding and how close to recruiting all the volunteers they need?

J&J - target 60,000, completion months away
CanSino - 45,000, months away but given to undisclosed number of Chinese soldiers
Pfizer/BioNTech - 44,000, 90% recruited, less than a month away
Oxford/AstraZeneca - 54,000, six months away
Moderna - 30,000, fully recruited
Novavax - 39,000, months away
Sputinik V - 43,600, 30% recruited, months away. Running into trouble. Their grandiose plans for mass vaccination are on hold as they are having trouble keeping the vaccine stable and scaling up production.
Sinopharm, 2 vaccines - 60,300 total, one large with 45,000, almost fully recruited (weeks away), the smaller ones months away. Also, these two vaccines in total have been given to 350,000 front line and consular Chinese workers under an EUA.
CoronaVac - 28,000, the Brazilian segment with 13,060 90% recruited, weeks away. One of the small ones, fully recruited. The other small one and the other large one (Turkey), months away. However it's been already given to 50,027 employees of the company outside of a trial but with follow-up; 0.03% serious reactions with no deaths, a bit more than 5.3% of moderate reactions.

So the Russians are running into trouble, and the front runners are Moderna, Pfizer, and the CoronaVac.

Interesting to notice that with the trouble that Oxford/AstraZeneca had (transverse myelitis and MS) they are no longer front runners.

It's been leaked that the J&J case that halted temporarily their trial was a stroke in a young man. It's been considered unrelated to the vaccine so the trial resumed. The young medical doctor (28 years old) who died in the Brazilian CoronaVac trial received placebo so that trial did not halt.

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My trust in Moderna has been deteriorating. They never published their phase 2 results with 600 patients. It's been reported that their chief medical officer has been selling stock at a profit rate of one million dollars per week. What's up with Moderna? They published phase 1 and another small subgroup of phase 1. Their side effects are higher end. I wonder how successful this one will be, although it's the only one that has achieved a phase 3 target.

I think the biggest hopes now are the Pfizer vaccine for the American population (but it's the one that needs deep cold chain) and the CoronaVac for the other countries that are part of it (won't be coming to America).

 

The big news that I somehow missed yesterday (I was distracted with the presidential race) is that Pfizer has announced that after the independent Data and Safety Monitoring Board (which knows who is taking placebo, who is taking the active shot) looked at 94 infections in the volunteers, their vaccine appears to be 90% effective. This opens the door to an application for FDA Emergency Use Authorization by the end of November. Such authorization would likely be approved by the FDA given that they have established the threshold at 50%. Pfizer then would move to delivery of the first batch of vaccines by the end of December, and immunization of high risk populations, healthcare workers, and first responders would ensue, followed by more segments of the general population in the first semester of 2019. Pfizer said they are in the measure to offers some hope.

The funny thing is that Mike Pence immediately moved to giving credit to Pence and the Warp Speed initiative, which was immediately followed by the company clarifying that they were not part of the Warp Speed initiative and took no R&D money from the US government.

I've been saying here forever that Pfizer wasn't part of the Warp Speed Initiative, and it seems like the freaking Vice-President of the United States and supposed chairman of the Covid-19 Task Force doesn't know it, LOL. Or more likely, simply does, but wants to mislead the public anyway. Liar, liar, pants on fire; Pfizer took care of fact-checking his bluff right away.

It is ironic that in the twilight of this disastrous administration, it seems like an effective and safe Covid-19 vaccine is coming after all, is the first one and the winner of the race, but has NOTHING to do with their Warp Speed initiative. That is, without the Warp Speed, this would be happening anyway. So much for Trump's attempt at a positive legacy on Covid-19 after his disastrous mismanagement of it...

 

Now all you have to do is convince enough people to take it.

 

With 43,358 participants in their Phase 3 Trial, Pfizer reports "no serious safety concerns have been observed." Great news.

Pfizer has signaled that the two months required by the FDA to observe the volunteers for adverse reactions will conclude by the third week of November, opening the door to the application for the Emergency Use Authorization before the end of November.

 

That's a big hurdle. I know that I will take it as soon as available and so will my wife; it should be available to us sooner than for the general population, given that we are healthcare professionals. But the latest data I saw regarding polls asking that question, I don't recall the exact numbers but I remember that the number of people saying that they would take the vaccine was in the 40%'s. The flu shot is only accepted by about 46% to 48% of the adult population, and apparently acceptance of the Covid-19 shot will be even lower. A very strong educational campaign would need to happen.

It would help a lot to have Trump be the champion of that educational campaign while he is in office, so that the half of the country who support him, see the vaccine more favorably. I don't expect that Trump, a selfish antisocial, will do this, though. I think he will adopt a scorched earth strategy and will do his best to sabotage the Biden administration, so he will do nothing that would contribute to a Biden effort to bring this pandemic under control.

I don't doubt that the Biden administration will try to promote the safety and the efficacy of the vaccine, but then, the other half of the country won't listen to him, especially with Trump's ongoing efforts to delegitimize the results of the election.

 

This interview angers me.

https://www.yahoo.com/lifestyle/experts-weigh-in-pfizer-covid-19-vaccine-171625902.html

Way to go to undermine public trust, ass..h... (this is for Dr. Poland).

The operational words here are these:

"But Dr. Gregory Poland, a renowned vaccinologist and head of the Mayo Clinic’s Vaccine Research Group who is on the review board for several COVID-19 vaccines (but not Pfizer’s)"

You guys need to understand something about big pharma and academia - almost everybody in a high position of leadership in research organizations has ties with, gets money from, and has interests in many of the big pharma companies.

The first vaccine to cross the threshold will be a THREAT to competitors. Not as many people will enroll as volunteers in the other trials, being blind to a 50-50 chance of getting a placebo, and having to show up for 2 years worth of antibody tests, if the person can get an approved, safe, and efficacious vaccine from the nearest Walgreens, guaranteed not to be a placebo. The existence of an approved vaccine will undermine other phase 3 tests; subjects will drop out or not enroll.

So, Pfizer having their product approved first, will be a huge blow to the competitors.

So, this guy highlights what we know as post-market experience (without naming it; it intentionally appears like the hundreds of thousands he is talking about relate to some sort of additional study needed that neglectfully wasn't done, when it's not like this that we proceed. This is true for ALL vaccines and also ALL medications, for that matter. We won't know the post-marketing data until, duh, the vaccine is approved and in the market. But that's not something needed for approval and distribution, dammit! 43,000 subjects in a phase 3 is more than enough!

Yes, the virus could mutate, but that's precisely why the sooner we get this vaccine distributed to our population, the better, because if we can catch the virus before it mutates, and if enough people accept this vaccine (at 90% efficacy, which is GREAT), we can interrupt the chain of transmission before the virus mutates.

Also, he falsely characterized the Pfizer phase 3 trial as not looking into minorities and older populations. In fact the company spontaneously extended its Phase 3 trial from 30,000 subjects to 43,000 and change, exactly to include these populations.

This guy is clearly, under the guise of being concerned and under the guise of quoting some correct ideas (yes, of course we'll need the full data rather than the press release, but it's coming), trying to undermine the Pfizer product, and I don't like it.

 

The same day we got the good news from Pfizer, we got bad news from Brazil. Their FDA, ANVISA, has halted the CoronaVac trial, due to a serious adverse event. No specification of what the adverse event was. Just, that it occurred on 10/29, which is strange; it usually doesn't take 10 days for that. There is a rumor that it was a death. It's even more unbelievable that a death would stay uncalled, for more than 10 days. I have no more details at this time. Will try to learn more.

 

OK, I got more news from Brazil. Dimas Covas, the head of the Butantan Institute, said he is appalled at ANVISA's decision to halt the trial, because yes, it was a death, but UNRELATED to the vaccine. Although he didn't say so, it appears clear that this is another manifestation of the war the Feds in Brazil, under far-right president Bolsonaro, is waging against governor Doria of São Paulo, who is from an opposition party, the PSDB (Social Democracy). The State of São Paulo owns the Instituto Butantan. São Paulo and the Butantan have been negotiating with China, and the Feds oppose China and don't want the CoronaVac, but rather, want the Pfizer and the Oxford/AstraZeneca products. OK, so, it seems like it's a case of politics influencing science.

Two other strange aspects: the death happened more than 10 days ago. If ANVISA's concerns were justified, they would have stopped the trial immediately. The delay smells of political pressure being the culprit. Second, ANVISA didn't even notify Dimas Covas. He learned it through the press!!!

This is not kosher. I think this is president's Bolsonaro's doing. He is trying to damage the CoronaVac, for political purposes. Like I said, Bolsonaro is worse than Trump.