The state of the vaccines

I agree, without data changing the regime for the Pfizer vaccine makes no sense at all.

Thanks for posting the data on the AstraZeneca trial, the data is a bit of a mess. It looks like they are looking at the data for the Brazil trial as the reasoning behind getting as many people to have their first injection. I see gaps in the analysis, the Brazil trial didn’t have any specific actions to look at the effect for older people around 70 plus as the focus was on health care worked 18+.

To me it would make sense to have a mixed approach, keep the Pfizer at 21 days, for older people with the AstraZeneca follow the Uk findings so within 4 weeks and within 12 weeks LD/ SD for others.

 

These questions will be answered in the American trial. I think they have recruited 29,000 people already. I wouldn't trust the AstraZeneca shot until a clean, standardized, valid trial without all these methodology burdens is performed.

I'm quite astonished at how badly AstraZeneca, an otherwise excellent company, botched this. And that's the one we bet the most on, here. We pre-ordered 300 million doses... if we had a clean set of data we would be able to have enough for almost half of our population. I'm quite dismayed at the mess that the AstraZeneca trial demonstrated. Not to forget, they did have a case of transverse myelitis. So in a sense, for us, Americans, it's good that you guys have approved it. We'll be watching what happens in the post-marketing phase (also informally known as phase 4) when you guys give it to millions of people. If transverse myelitis starts popping up with alarming frequency...

 

@CenterField, in the veterinary world we sometimes use different formulations by different companies for a booster. But we’ve done the research to know it works. I wasn’t aware there was ongoing research on doing this with the C19 vaccines, but if the research concludes it will work (which in theory it should, with mRNA being the unknown wildcard) I would be comfortable boostering with a different formulation. Without research—Hell no.

 

Yes, of course. This is why I said, a study is underway but hasn't concluded. Once it concludes, if it is all good, then, by all means. Before the study concludes, I think governments should stick with what the phase 3 trials did.

 

Another question/observation:
We hear for example that a vaccine achieved 95% efficacy calculated during the trials. So 95 out of every 100 are predicted to get immunity when given to a population. For those other 5 out of 100, can they achieve immunity if given another set of doses of the vaccine at a later date or do they have a biological difference to the other 95 people meaning that the vaccine will never work for them? ie just wondering if the body reacts to a vaccine in different ways depending on the time it is given or is there something in some people that destroys the vaccine before it had time to work

The Oxford vaccine has an efficacy of around 70%. If immunity achievement of people is random (depends on time given as explained above), then giving everyone two sets of doses (2 doses per set), say 3 months apart, will achieve 91% efficacy. The Oxford vaccine is cheap and easy to mass produce and easy to distribute.

 

OK, now we got a bad case in Mexico. A 32-year-old female doctor was hospitalized and admitted to an ICU with seizures, a rash, and trouble breathing, after receiving the Pfizer vaccine. Her treating doctors suspect encephalomyelitis. That's not good. While these reactions are not uncommon when a vaccine is delivered to millions, it is terrible for the vaccine's reputation and undermines public confidence.

 

With vaccines that use different platforms, it is conceivable that different people and/or different demographics may react differently to different vaccines.
Say, someone doesn't get a great result with an mRNA vaccine but gets a better result with a vaccine that uses inactivated whole virus or protein subunits. Certain age groups may react better to certain platforms than others. And other regimens may be more efficacious. Say, two boosters instead of one: day 1, day 21, day 42... who knows? These are all Emergency Use Authorization. We may have second generation vaccines a couple of years down the road or fine-tuned regimens that will do better than what we have now. But 95% efficacy is already super good and actually unusual for respiratory viruses.

Yes, the Oxford vaccine has advantages of being cheap and stable. And 70% efficacy is not all. You have to also look at the efficacy in not only preventing the disease (70%) but also preventing serious and fatal disease (might be as high as 100% since nobody in the vaccinated arms of the Oxford/AstraZeneca trials developed severe disease).

 

I've just learned from a foreign language news site, that as of today, 12,623,018 people have been vaccinated against Covid-19 in the world. This uses official data and I happen to know that due to a lag in reporting, here in the United States we have had about 700,000 doses that went into people's arms but haven't been counted yet. So, 13,323,018, roughly. Vaccines that have been delivered into people's arms around the world: Pfizer/BioNTech, Moderna/NIH, Sinopharm/Beijing, Sinopharm/Wuhan, Cansino, CoronaVac, Sputinik V, and Oxford/AstraZeneca. Two mRNA vaccines, 4 inactivated virus vaccines, and 2 adenovirus vector vaccines, so, 3 different platforms, varying in efficacy from 62% to 95% for the disease, and practically 100% protection against severe disease (in all trials of all vaccines so far, only ONE person - in the Pfizer trial - developed severe Covid-19 - but did not die).

Severe reactions to the vaccines, that I know of:

Four in the United Kingdom (two of which in trials - Oxford/AstraZeneca (transverse myelitis), and Janssen (stroke), leading to a temporary stop in trials - two post-marketing cases of anaphylaxis in Scotland)
Six anaphylaxis cases in the United States
One case of encephalomyelitis in Mexico (today)

Eleven people, none of whom have died so far, ten of whom have fully recovered; even the stroke case was mild and recovered nicely - the only pending case is the Mexican one; I do not know yet how the woman in Mexico is faring, she's been admitted to an ICU).

That's one serious but non-fatal reaction for each 1,211,183 doses. Even if the woman in Mexico dies, then it's 1 fatality in 13,323,018 cases.

I'd say, pre and post-marketing experience is showing that the the vaccines are safe.

Let's put this into perspective. Let's apply to these 13,323,018 people, the American current case-fatality rate (to be conservative; other countries have had numbers even higher) of 1.8%.

So, if these 13,323,018 people contracted the virus, we'd expect at least 238,814 deaths.

As for severe reactions, the virus steadily causes 20% of severe cases needing hospitalization. This number also matches the current estimates in sequelae. One in five.

So, for these 13,323,018 people, 2,664,603.

Do you guys realize the enormity of this? Without the vaccines, 238,814 deaths. With the vaccines, 0 or 1 deaths (in case the Mexican woman dies which is far from a given). Without the vaccines, 2,664,603 severe issues. With the vaccines, 11.

Anybody who's been saying that he/she doesn't want the vaccines; care to reconsider?

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PS - I do acknowledge two caveats:

1) Maybe these 13 million people wouldn't have a CFR of 1.8%, could be lower, as low as a third of that, 0.65%, due to asymptomatic and undiagnosed cases bringing down the actual IFR a(infection-fatality rate) s opposed to the CFR (confirmed case-fatality rate). But the 20% of estimated sequelae remain valid even for asymptomatic cases, like recent studies show (for example, 15% of heart damage in asymptomatic college athletes).

2) Maybe there's been more serious reactions in less transparent countries that we don't know of, like Russia and China.

Still, even with the caveats above, the benefits of the vaccines far outweigh the risks, but HUGE numbers.

 

India has just approved the Oxford/AstraZeneca vaccine, the second country to do so.

 

India has approved the Bharat Covaxin vaccine, a locally made one, BEFORE the conclusion of their phase 3 trial, thus joining Russia in being the only other country that has approved a locally-made vaccine without the proper safety and efficacy data. In the grapevine, it is suspected that the Covaxin has about 60% efficacy.

 

Operation Warp Speed is considering giving 50 micrograms of the Moderna vaccine times two doses to people aged 18 to 55, instead of the full dose of 100 micrograms, in order to increase the number of available doses, a position that Fauci has criticized. There is some data indicating that for this age group, half dose achieves the same immunogenicity. The FDA would have to approve the move.

I am ambivalent about it. Yes, we need more vaccines. But most likely we should stick with what the clinical trials have recommended and shouldn't deviate from the doses. More important than doing that, would be to expedite delivery and administration of our existing stock.

I'm kind of glad that the first dose of the vaccine my wife and I got, was the Pfizer one. So far, no plans are being made to change the regimen for the Pfizer vaccine. I'd rather have my second dose 21 days after the first one and at the right dose.

 

Bharat Biotech / Indian Council of Medical Research / National Institute of Virology product BBV152, nicknamed Covaxin, is the new kid to be approved by a country. Like the Sputinik V, it was approved by the country that makes it, India, WITHOUT a phase 3 trial, which only started in November and hasn't concluded. Their Phase 3 has enrolled 23,000 subjects. Their target is 26,000. India's FDA-equivalent, called DCGI, issued a full EUA for this vaccine.

Immediately 10 countries manifested interest in purchasing it, despite the lack of data. There is a rumor that the vaccine is 60% effective after a second dose. It is a vaccine made with inactivated whole SARS-CoV-2, therefore comparable in platform to the products from Sinopharm Beijing, Sinovac/Instituto Butantan, and Sinopharm Wuhan.

An association of PRIVATE health clinics in Brazil has immediately jumped into purchasing 5 million doses; likely it will be given to rich people, outside of the national vaccination program.

 

Correction for post #383 - I counted the platforms wrong. I should have said 2 mRNA vaccines, 3 inactivated virus vaccines, and 3 adenovirus vector vaccines currently being given to people outside of trials. With the Bharat Covaxin, another inactivated one, the platforms now currently already in use are 2 mRNA, 4 inactivated virus, and 3 non-replicating adenovirus vector.

The next two that should earn approval, should be the Novavax, and the Janssen. This will introduce another platform, the protein subunit for the Novavax, and add another adenovirus vector vaccine (4 of these, them).

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There are three a bit more obscure others that have reached phase 3 too. I have little information about them.

One is from the Research Institute for Biological Safety Problems of Kazakhstan, Inactivated virus, called QAZCOVID-AN.
One is from Anhui Zhifei Longcom Biopharmaceutical, a Chinese vaccine that is a protein subunit vaccine.
One is from Curevac, and is an mRNA vaccine

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So, I anticipate that in about three months, the world will have 14 vaccines in use:

3 mRNA (Pfizer, Moderna, Curevac)
5 inactivated virus (Sinopharm Beijing, Sinopharm Wuhan, CoronaVac, Bharat Covaxin, and Qazcovid-In)
4 non-replicating adenovirus vector (Oxford/AstraZeneca, Gamaleya Sputinik V, Cansino, Janssen)
2 protein subunit (Novavax, Anhui Zhifei Longcom)

Here are the ones we know efficacy data for, and approximate numbers, alleged or confirmed:

Pfizer 95% (rock-solid number, phase 3 completed) - approved and in use in the USA, Mexico, most of Europe, some Middle Eastern countries
Moderna 94.1% (rock-solid number, phase 3 completed) - approved and in use in the USA
Sinopharm Beijing alleged between 79.3% and 86% (no details provided, phase 3 supposedly completed but not yet published) - Approved and in use in China, Bahrain, and United Arab Emirates
CoronaVac >60%, <90% is all that the Brazilian scientists said so far; the Turkish ones said 91.25% preliminary (phase 3 completed in Brazil, ongoing in Turkey) - in use in special populations in China, not yet approved elsewhere
Oxford-AstraZeneca, controversial, between 62% and 90% due to a botched dose variation in trials, more likely 70% (phase 3 completed, then restarted to resolve controversy) - Approved and about to start use in the UK and India
Gamaleya Sputinik V, 91.4% if we trust the somewhat suspicious data, sizable preliminary data, phase 3 ongoing - Approved and in use in Russia and Argentina

Vaccines in phase 3 with no efficacy data publicly known yet (asterisk denotes vaccine already in use or starting use this week, despite lack of efficacy data):

Curevac
Sinopharm Wuhan* - in use in special populations but not approved for general use yet
Bharat Covaxin* - approved, about to start use this week
Qazcovid-In
Cansino* - in use in special populations but not approved for general use yet
Janssen
Novavax
Anhui Shifei Longcom

 

We got to 4.23 million doses administered to people in the United States, as of now.

 

Number of vaccines administered per country (second number is the most recent; repeated when it's the only info available)

Argentina 700 in Dec 29 32,013 in Dec 31
Austria 6,000 in Dec 30 6,000 in Dec 30
Bahrain 51,556 in Dec 26 60,689 in Jan 3
Bulgaria 1,719 in Dec 29 4,739 in Jan 1
Canada 48,884 in Dec 26 112,246 in Jan 2
Chile 8,337 in Dec 26 8,648 in Dec 27
China 4.50 million in Dec 31 4.50 million in Dec 31
Costa Rica 2,455 in Jan 3 2,455 in Jan 3
Croatia 7,864 in Dec 30 7,864 in Dec 30
Denmark 6,145 in Dec 27 40,541 in Jan 3
England 786,000 in Dec 27 786,000 in Dec 27
Estonia 207 in Dec 28 2,517 in Jan 3
Finland 1,767 in Dec 31 1,767 in Dec 31
France 332 in Dec 30 516 in Jan 1
Germany 21,566 in Dec 27 238,809 in Jan 2
Greece 1,763 in Dec 30 3,001 in Jan 2
Hungary 1,094 in Dec 28 5,110 in Dec 31
Iceland 4,875 in Dec 30 4,875 in Dec 30
Ireland 1,800 in Dec 31 1,800 in Dec 31
Israel 279,300 in Dec 26 1.09 million in Jan 2
Italy 8,361 in Dec 29 114,349 in Jan 3
Kuwait 2,500 in Dec 28 2,500 in Dec 28
Latvia 573 in Dec 29 573 in Dec 29
Lithuania 2,270 in Dec 28 2,270 in Dec 28
Luxembourg 1,200 in Dec 30 1,200 in Dec 30
Mexico 6,824 in Dec 27 24,998 in Dec 30
Northern Ireland 31,016 in Dec 27 31,016 in Dec 27
Oman 1,717 in Dec 29 7,231 in Jan 2
Poland 2,000 in Dec 28 47,600 in Dec 31
Portugal 4,828 in Dec 28 26,850 in Dec 30
Romania 2,066 in Dec 28 13,596 in Jan 3
Russia 800,000 in Jan 2 800,000 in Jan 2
Scotland 92,188 in Dec 27 92,188 in Dec 27
United Kingdom 944,539 in Dec 27 944,539 in Dec 27
United States 1.94 million in Dec 26 4.23 million in Jan 2
Wales 35,335 in Dec 27 35,335 in Dec 27

World 4.53 million in Dec 26 12.34 million in Jan 3

 

@CentreField
Now the new strain discovered in South Africa has been shown to have mutated protein spikes and may not respond to the current vaccines will we all need two versions of the vaccine?
One to cover the old strains and another to cover the new one?

 

It's possible. Or one new vaccine as the new strain is likely to become dominant. But let's not panic yet. It's not been demonstrated that the new strain will evade the vaccine. It's possible that it will but not a given yet. The main issue with the two new strains is that they seem more infectious. Look at this:

 

The FDA has issued a strong declaration that all these ideas and attempts to change the authorized doses and schedule are inappropriate. These vaccines should be given full dose and with the established interval (21 days for Pfizer and 28 for Moderna). Period. Until a time when evidence from trials might exist that it is safe to do otherwise, people trying to change it are playing with fire.

https://www.fda.gov/news-events/pre...authorized-dosing-schedules-covid-19-vaccines

 

A third country (after the USA and Canada) has approved the Moderna vaccine: Israel.

 

BBC Urges NYT to Correct “Misleading” Coronavirus Article
Eric Worrall
The BBC and British Medical Journal has accused the New York Times of getting their facts wrong on Coronavirus vaccines, but the NYT appears to have doubled down on their…

 

Yes, absolutely. No changes in dosing and schedule should occur without data. Enough of these approaches that ignore Science. Injecting bleach doesn't work either.

 

It's a difficult one with the Oxford vaccine, a cheap vaccine. The UK is facing a huge number of deaths and cases and not enough vaccines. So a balance is needed - the benefits of vaccinating twice as many people with one dose quickly as possibly achieving a lower efficacy compared to half of the people achieving a higher efficacy in the same time frame. Though not tested in the trials perhaps three doses with the last two doses being given at the recommended time schedule

 

A doctor died in Florida of a hemorrhagic stroke on 1/4/2021, a couple of weeks after he got the first dose of the Pfizer vaccine on 12/18/2020. His wife, as far as I know not a qualified physician or scientist, posted on Facebook blaming the vaccine for her husband's death. According to doctors who treated him, he presented thrombocytopenia, a decrease in the number of platelets, which can lead to internal and external bleeding as it affects the ability to form blood clots. Yes, thrombocytopenia can cause hemorrhagic strokes, typically if it falls below 20,000; under 50,000 is very concerning; under 20,000 is critical.

Now, the issue is, many medical conditions and medication can cause thrombocytopenia. For example, some cancers, some forms of anemia, heavy drinking, several viruses, some genetic conditions, toxic chemicals and some medications such as Depakote, diuretics, chloramphenicol, etc. In the Pfizer trials no case of thrombocytopenia was seen. To be fair, it is not impossible that this is related to the vaccine as it's been rarely seen in other vaccines like the MMR, but it is far from likely or proven.

A vaccine being given to millions, will be also given to people who will die of other causes, given that the only requirement for a human being to die, is to be alive in the first place. Yeah, people die. They regularly do. If you vaccinate millions, among these millions people will continue to die of whatever would have killed them even without the vaccine.

So it is irresponsible for this wife to prematurely go on Facebook and blame the vaccine. Sure, I feel for her loss, but while I do acknowledge that it is marginally possible that this vaccine might be associated with thrombocytopenia in rare cases, it warrants investigation (which is ongoing) to see if causality can be established, or if this is merely a correlation. Statistically speaking the odds of merely a correlation are overwhelming, given the multiple other causes of thrombocytopenia and the absence of any impact on platelets during the Pfizer trials (which, yes, doesn't completely exclude it).

If any person who dies of some unrelated cause after taking the vaccine is attributed in social media to the vaccine, we'll run into acceptance problems among the population, resulting in a lot MORE people dying.

The lay press is likely to bombard us several times per month with bombastic articles about someone dying after taking the vaccine.

 

This is tempting and sounds like good common sense, but it isn't. Read the reasons why, in the FDA statement I linked to, in post #393. Thanks.

The main issue is, we have no evidence whatsoever that the proposed regimen change will work. For all we know, if NOT given the booster timely, immunity may drop dramatically, creating what the FDA warns against: that people assume they are protected when they aren't, and then they more easily engage in risky behaviors, ultimately increasing (rather than decreasing) the overall risk.

Also, doctors and organizations willing to alter the terms of the Emergency Use Authorization, at least in the USA, are playing with fire in terms of malpractice. It is inevitable that if people then contract Covid-19 and die or survive but with permanent organ damage, they will sue the provider, given that the provider disrespected the currently authorized terms. And I'll tell you what: these plaintiffs would easily win those lawsuits, especially after the FDA issued the warning I've just mentioned. Imagine the plaintiff's lawyer saying in a court of law, in front of a jury: "You call yourself a doctor, but you ignored this explicit warning by the learned scientists of the FDA and the learned scientists from the company that made this vaccine??? Then, look at what happened to my client!!!"

 

Great new, the phase 3 data on efficacy and safety of the CoronaVac, the inactivated virus vaccine developed by Sinovac from China in collaboration with Instituto Butantan from Brazil, were finally released.

This is the result: the vaccine is 78% efficacious in preventing infection with the SARS-CoV-2. The best part: it is 100% efficacious in preventing moderate and severe infection, and hospitalizations. Nobody in the vaccinated arm developed any worse than a mild case of Covid-19 and nobody needed to be hospitalized. Also, the safety profile is excellent with no serious reactions whatsoever; seems safer than the product of some competitors.

The Instituto Butantan has filed an Emergency Use Authorization application with ANVISA, the Brazilian FDA. Brazil has voted a bill into law that says that if a vaccine has been approved by one of four FDA-equivalent agencies: the American one, the European one, the Japanese one, or the Chinese one, ANVISA must rule on the application within 5 days of it being filed, and if they don't, then it's considered to be approved. Given that with this result, most likely the Chinese FDA will approve it, the Brazilians are in good shape (finally) to have a Covid-19 vaccine, after the obstructionism sponsored by their idiotic president Jair Bolsonaro.

I follow this with great interest because in the past I worked in Brazil several times in collaboration projects, I still have close friends there, and I speak fluent Portuguese. So I hope they get this done because they direly need it, and it would be good to see Bolsonaro's anti-scientific efforts to thwart the vaccine, fail. Jair Bolsonaro has managed to be even worse than Donald Trump, in his botching of the pandemic response. Trump at least promotes vaccines, while Bolsonaro works against them, has said literally that people will turn into alligators if they take it (LOL, no kidding), and has said he won't take the vaccine himself if one is ever approved. He has tried to sabotage purchasing orders as well. What a full-blown idiot! Meanwhile his country has the second biggest death toll in the world.