The state of the vaccines

Politics threaten to cloud EU countries' pause of Oxford ...
https://www.politico.eu › article › politics-threatens-clo...


Mar 16, 2021 — It's the second time numerous EU countries have diverged with the European Medicines Agency over the Oxford/AstraZeneca vaccine.

 

Sure it's politics. Because scientifically speaking, the benefits of the vaccine clearly outweigh the risks. Yes, there are risks, like for all medications and all vaccines known to men. The complications from the vaccines, though, are rarer than those caused by the virus. Still IN CASE A COUNTRY HAS SEVERAL APPROVED VACCINES I'd reserve the AZ shot to those who are at a much smaller risk for this complication (men and people older than 60). But if a country has no other option I'd continue the campaign.

 

Pfizer/BioNTech vaccine: effective 100% for kids 12 to 15, big help coming for school reopening.

 

Truly excellent news from Pfizer/BioNTech:
Their vaccine conserves efficacy for at least 6 months after the second dose, at 91.3%
SURPRISE: Unlike all others, it showed excellent efficacy against the B.1.351 South African strain, brace for it: 100%!!!
100% efficacy for children 12 to 15 like I mentioned before.
100% efficacy against severe disease in one definition, 95% in another one, for all populations.
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Moderna is starting the phase 1 trial (210 subjects) of their updated vaccine against the B.1.351.
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The United States is now at 29.11% of the population having received at least one dose of a Covid-19 vaccine.
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Good news above, but one bad news:
A mixing error at the factory spoiled 15 million doses of the Johnson and Johnson vaccine and resulted in the factory not being certified, which will delay their ability to meet the target of delivering 100million doses to the United States.

 

Germany now recommends that if someone is younger than 60 and got a first dose of AstraZeneca vaccine, the person shouldn't take a second dose but should rather take one of the mRNA vaccines 12 weeks after the first dose.

 

I don't think the Euro effort could be more screwed up.

 

Indeed. Disappointing. Gives great ammunition to Euro skeptics. Which is bad. I don't want to see more countries abandoning the European Union.

 

Which are least likely to be influenced by "new strains" ?



Moi

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Anybody interested in considerations about the CDC/FDA recommended pause of the J&J vaccination in the United States secondary to the VERY rare CVST blood clots the vaccine may cause (a move I absolutely disagree with), can consult this thread - I thought the issue deserved its own thread but it's good to put a link here because it is very pertinent to the State of the Vaccines topic:

http://www.politicalforum.com/index...due-to-blood-clots-is.586960/#post-1072566885

 

Vaccine efficacy stats in the United States: The CDC has released data that among 66 million fully vaccinated Americans, 5,800 got infected and of those, 396 needed hospitalization and 74 died.

What this means in percentage is that only 0.008% of fully vaccinated people caught the virus, and only 0.0001% died.

These are excellent news and demonstrate how HIGHLY EFFICACIOUS these vaccines are.

But I'm sure the anti-vaxxers and alarmists will rather focus on the 5,800 number, or the 74 dead, instead of focusing on how tiny the percentage is.

Nobody ever said that these vaccines are 100% protective, so breakthrough infections and even some deaths will continue to happen among the vaccinated, but percentage-wise, these are very very small numbers. These vaccines are an astounding success.

 

Piece of good news: the Moderna updated shot meant to curb the P.1 (Brazilian) and the B.1.351 (South African) strains worked well in animal studies, showing good immunogenicity against both the ancestral strain and the new strains.

https://www.biorxiv.org/content/10.1101/2021.04.13.439482v1

 

A large study in Chile involving 10.5 million people found that CoronaVac, the Chinese vaccine developed by Sinovac, performed well. It reduced hospitalizations by 85%, intensive care by 89% and deaths by 80%. This is not quite the performance of the Pfizer and Moderna vaccines but it is quite significant for the Third World. I'm happy for this result.

 

The CDC panel met today to consider the J&J vaccine. If the CDC director abides by their recommendation, we are to resume J&J shots, with a fact sheet and warning about blood clots and how to treat them.

15 cases of blood clots were found, a dozen of which were CVST, and 3 of which died. All 15 were in women aged 18 to 50. No cases were found among men. No cases were found in people over the age of 50. The 15 cases were found out of nearly 8 million recipients.

If the director of the CDC signs off on this recommendation, J&J shots will resume in America in a matter or hours to days.

It remains to be seen how the public will react to this. Of course, men have nothing to fear. Women over the age of 50 have nothing to fear. But women aged 18 to 50 might want to prefer Moderna or Pfizer, despite the risk being statistically very small and much smaller than the risk of blood clots brought about by Covid-19 itself.

Given the less than 0.0002% risk of blood clots for the vaccine versus 16% to 21% for the virus itself, I sustain that it's a no-brainer that the vaccine's benefits far outweigh its risks, but since we do have the alternatives of the Pfizer and the Moderna vaccines, I'm fine with the idea that women aged 18 to 50 should prefer one of the other two vaccines, and that's what I intend to tell my patients.

 

The Israelis are investigating reports of myocarditis (inflammation of the muscle fibers of the heart) associated with the Pfizer vaccine. Before people panic if they get this from anti-vaxxer sites or lay journalists, let me clarify:

1. These cases seem to be transient and harmless
2. These cases seem to be very rare
3. These cases DO NOT appear to be statistically more frequent than those spontaneous myocarditis cases expected in the non-vaccinated general population, making it likely that it's not the vaccine that is causing them
4. There is NO proven relationship whatsoever between these cases and the Pfizer vaccine
5. The SARS-CoV-2 virus itself causes myocarditis in HUGE numbers, including in mild and asymptomatic cases, and including in young people with no pre-existing heart conditions; stats in studies have varied from 30% (a study by the Ohio State University, including in young college athletes that had mild or asymptomatic cases of Covid-19) to a whooping 60% (a study out of Frankfurt, Germany that also found other heart issues, for a total of 78% of Covid-19 survivors including those with mild and asymptomatic cases who came out of it with some heart issue) - I've repeatedly published links to these studies, before.

For me, the most likely explanation is that these cases were caused by the SARS-CoV-2 virus itself. Most likely people had mild or asymptomatic cases of Covid-19, didn't even know they had it, and got the vaccine when their appointment came up... I assume the vaccine is indicated in Israel for people who have had Covid-19; at least here in America, it is. So, if you go looking for myocarditis in vaccinated people, you'll likely catch cases among those who have had Covid-19 unbeknownst to them, and then had the vaccine, and it's the virus that caused it, not the vaccine.

Pfizer has issued a statement saying that they did not find any case of myocarditis in their clinical trials associated with their vaccine.

For me, this is another alarmist piece of news, and it is regrettable.

Here is the REAL risk of myocarditis: the SARS-CoV-2 virus.

Take the vaccine.

 

Another coronavirus vaccine has achieved mass inoculation in at least one country.

Kazakhstan has started mass vaccination with their own vaccine called QazVac.

They have limited production capacity. They made so far 50,000 shots. It's supposed to be given in two shots, 3 weeks apart.

It is still in phase 3 trials (supposed to conclude in July) but they decided to approve it and start vaccination anyway (like the Russians did with the Sputnik V). Preliminary results point to a possible efficacy of 96%.

This vaccine is based on inactivated virus (like the Chinese CoronaVac) and is stored at 2 to 8 degrees centigrade.

Kazakhstan also makes on site the Sputnik V, out of an agreement with Russia.

Their population of 18 million people so far has received about 1 million doses of Sputnik V.

Despite the small production capacity, Kazakhstan is proud of having joined the elite club of countries capable of developing and producing their own Covid-19 vaccines: the United States, the United Kingdom, Germany, Russia, India, and China. Other countries about to cross this threshold are Cuba, Italy, and Brazil. Australia tried but did not succeed; the same happened in France.

 

Regulators in Brazil (ANVISA, their FDA) rejected the Sputnik V vaccine.

The Russians claimed it's political because Brazil's president Jair Bolsonaro is generally against Russia and China, and there is a suspicion that he placed loyalists into ANVISA.

However, international scientists actually agree with the Brazilian scientists who vetoed the Sputnik V. The issue was, the Brazilians discovered that the second shot, the one with the Ad5 (Adenovirus strain #5, as opposed to Ad26 that the Russians used for the first shot) was replication-capable.

This adenovirus-vector vaccine is suppose to have non-replicant adenovirus. However it seems like the Ad5 re-acquired the genes necessary to replication, during cell culture to make the vaccine.

What is the problem with that? None, for healthy individuals. Adenoviruses are benign common cold viruses. But it could be a problem for immunocompromised individuals. And it is a quality-control issue. These adenoviruses were not supposed to reacquire replication capacity. That's a manufacturing default.

So the Russians are saying that it is not true.

But it's not the first time the Sputnik V presents manufacturing issues. Scientists in Slovakia have complained that the batches they received did not contain the same formulation of the Sputnik V used in clinical trials.

Gamaleya Institute should embrace these manufacturing problems, say oops, and work to correct the issues in a transparent manner.

But... it's too much to hope for transparency from the Russians.

So, the Sputnik V now adds its troubles to the long list of issues that some of these Covid-19 vaccines have presented, which is not good for public confidence.

Oh boy, am I glad that my wife and I got the Pfizer shot!

 

At the risk of sounding prejudiced- why am I not surprised? If the vaccine manufacturing is at the same level as Russian auto manufacturing....................

 

We have mucked up the roll out something fierce! The government here decided all healthcare professionals had to do about six hours of mandatory online learning that is so badly constructed that you are down to randomly guessing answers to some questions : roll:

 

Covid-19 mRNA vaccines substantially better than natural infection to provide immunity:

https://www.biorxiv.org/content/10.1101/2021.04.15.440089v2

 

The FDA is about to approve the Pfizer shot for kids aged 12 to 15. Efficacy in this population, 100%.

 

No. It's not even a vaccine. I do not want any gene therapy death jab.

 

Pfizer and BioNTech have applied for full FDA approval for their shot, with 6 months of data and no additional safety concerns being raised. The FDA looks at 6 months to two years of data, in general, depending on the magnitude of post-marketing data and likelihood of long-term, tardive effects. It does make sense to apply for full approval with 6 months due to the sheer number of shots already given to people, 134 million Pfizer shots which is so much more than a 40,000-people trial (actually 20,000 because the other half is placebo). Also, the likelihood of tardive side effects is very small in this case (mRNA vaccines degrade in 8 hours... if what they do triggers for example an auto-immune reaction, it will be apparent in weeks, not months or years). Still, Pfizer anticipates that the FDA will take a few months to approve, and they are submitting rolling data to distance themselves more and more from the 6-month mark. Anyway, I had anticipated full approval only in 2022; I guess we'll have it in 2021, which is great because there will be the ability for employers, especially governmental, to require the vaccination rather than just suggest it. Full approval is also a psychological landmark. While the EUA merely indicates that the FDA believes that a vaccine has the potential to have more benefits than risk, a full approval is a seal of endorsement that the vaccine definitely has more benefits than risks, meaning that it is reality rather than potential.

So, I'm crossing my fingers that the FDA will issue a full approval relatively soon.

 

I am told spiritually that these "vaccines" (All or which ones i do not know) are dangerous and have no reason at all not to trust my source.

 

New kids:

CureVac and Novavax are close to regulatory approval (the former in Europe, the latter in the United States, Europe, South Korea, Canada, and the UK). CureVac's vaccine is mRNA (final efficacy data not yet in but expected within a month; approval could come within one or two months), and Novavax's is recombinant nanoparticle vaccine, with an efficacy supposed to be a whooping 96%.

Sanofi/GSK withdrew its vaccine due to low immunogenicity in the elderly. Now they refocused on making a new vaccine for variants, adjuvanted recombinant protein-based. They are running trials and hoping for approval in the fourth quarter, if the trials are successful this time, as opposed to their first candidate. GSK is also working separately on another mRNA vaccine, in partnership with Translate Bio.

 

My brain is going to explode at someone point in the immediate future.

Does this mean we will need the first vax and a second one for variants? Will this become an annual thing like the flu shot?