The state of the vaccines

Three international pieces of news:
Argentina has issued an EUA for the Sputinik V.
Mexico will start vaccination with the Pfizer vaccine tomorrow, 12/24.
Non-vaccine related, but covid-19 related: a ventilator used for Covid-19 exploded in a hospital in Turkey, killing 9 people.

 

CoronaVac efficacy in Turkey was said to be 91.25%. In Brazil, they say "it didn't get to 90% over here."
So, as I suspected, Sinovac didn't allow their Brazilian partners to divulge the number, because they were hoping that the Turkey and Indonesian numbers would be better so they wanted to pull together, all three, before a final announcement.

 

My mother had her first dose of the Phizer vaccine on Monday.
No ill effects at all.
She's 80 and has dementia.

 

One doctor in Boston had a severe allergic reaction to the Moderna vaccine. He self-administered his epi-pen (had a history of shell-fish allergy) and a couple of hours later was fine and discharged from observation.

 

The CoronaVac has been tested on at least about 21,600 people in their phase 3 trial: 13,000 in Brazil, 7,000 in Turkey (only preliminary results in 1,322 of these are available) and 1,600 in Indonesia. Some more in Chile but I don't know how many. Sinovac had planned a large phase 3 trial in Bangladesh but it didn't take off due to local issues.

That is a bit thin, and the contradictory leaked data undermine credibility. What we know is that Turkey mentioned 91.25% efficacy (but based on only 29 infections), Brazil reached sufficient number of infections for a meaningful number but did not reveal the number (they were prepared to announce it on 12/23 but Sinovac invoked a confidentiality agreement, stating that they wanted to combine data from all four countries before revealing one definitive number); the Brazilians did say that in their trial efficacy was bigger than 50% but smaller than 90%. Indonesia mentioned 97% then retracted that number saying that their data were still insufficient to reach a number, and Chile didn't say anything.

Sinovac said they will have the analysis of all four countries combined by mid January and will then release the number.

Scientists from two universities in Queensland in Australia have lamented these fragmented leaks, saying that the Chinese do not have a good track record on the safety issue, therefore, for the CoronaVac to be trusted, they would like to see very solid data.

Given that many developing countries are looking at the CoronaVac as a solution (it doesn't require refrigeration), the developing world anxiously awaits the final numbers.

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More vaccine news:

Meanwhile Argentina bet on the Sputinik V, and they have started mass vaccination with the Russian product, becoming the third country to approve it (after Russia itself and Belarus).

In Europe, several countries have started mass vaccination with the Pfizer/BioNTech product: the UK first, and now, France, Spain, Belgium, Germany, Hungary, Italy, Liechtenstein, Spain, Croatia, Cyprus, Czeck Republic, Denmark, Finland, Greece, Malta, Romania, Slovakia, Serbia, Switzerland, and Poland.

Other countries that have started vaccination campaigns: USA, Canada, Mexico, Costa Rica, Kuwait, Oman, Quatar, Saudi Arabia, and the United Arab Emirates.

Italy, an early epicenter, is in good shape: they have secured 202 million doses of the Pfizer/BioNTech vaccine, more than enough to vaccinate their entire population of about 60 million people (remember, two doses are needed, so they have enough for 101 million people, therefore they will have enough to vaccinate their entire population twice - given that the vaccine is not supposed to be given to youth younger than 16). So they are even prepared for a booster if immunity doesn't last very long.

Putin said he will be vaccinated with the Sputinik V on national TV. Russia has reiterated that subsequent data continues to point to an efficacy of 91.4%.

Singapore gave approval to the Pfizer vaccine and they have received their first shipment but haven't started the vaccination yet. The almost Covid-19 free country is seeing high number of doubters, wondering if they need the vaccine after all given that they successfully controlled the outbreak by other means. The prime minister said he will be the first to receive the vaccine, in order to set the example to the population. The "other means" saw some questionable moves by the authoritarian government: guest foreign workers were confined to their crumped quarters so that they don't contaminate the citizens.

India may become the first country to approve the Oxford/AstraZeneca vaccine. They are supposed to do it this week.

 

Novavax is starting its phase 3 trial in the USA, becoming the 5th company to do so. Other than the already authorized Pfizer and Moderna, AstraZeneca and Johnson & Johnson are already in phase 3 - as you know, AstraZeneca could have finished theirs but got into trouble with the half-dose controversy then expanded the trial to solve the question, and Johnson and Johnson is hoping to finish theirs by late January or early February. J&J hopes to apply for EUA in February if their vaccine is successful.

Novavax has a phase 3 trial already ongoing in the UK, and a phase 2b in South Africa. This current phase 3 trial will be done in the USA and Mexico and will involve 30,000 subjects.

Remember, Novavax's vaccine uses a protein subunit platform, completely different from the mRNA used by Pfizer and Moderna, the chimpanzee adenovirus vector RNA vaccine from AstraZeneca, and the human adenovirus 26 vector DNA vaccine from Johnson and Johnson (the latter is also studying a one-dose regimen).

 

Interesting article about China's struggles with their vaccines in terms of other countries trusting them:

https://www.yahoo.com/finance/news/china-struggling-world-trust-vaccines-210022111.html

 

Thanks for that link.

While not exactly on topic it occurred to me that the difficulty that China is having getting other nations to trust their vaccine is evidence that REFUTES the absurd conspiracy that China deliberately engineered and released the virus.

 

One of the two Sinopharm vaccines, made of inactivated virus, got efficacy data of 79% in Chinese trials and 86% in United Arab Emirates trials.
The Sinopharm shot has been approved in Bahrain and the United Arab Emirates.

 

A nurse in California developed Covid-19 symptoms 6 days after getting a dose of the Pfizer vaccine. The nurse works in a Covid-19 unit and most likely, due to incubation period, got infected at least 4 days after getting the vaccine if not earlier, so the vaccine did not have the time to help him. Pfizer has stated that the vaccine needs 10 to 14 days to start inducing some immunity, which then gets to about 50% protection, and only one week after the second dose this protection raises to 95%.

Before the conspiracy theorists say it, no, the vaccine didn't give Covid-19 to the nurse; that's impossible given that the vaccine only contains a fraction of the virus' genetic code.

 

Wrong thread, oops

 

The United Kingdom has approved the AstraZeneca/Oxford vaccine, the first country in the world to do so.

 

Is the Oxford vaccine single dose?

 

two doses

 

The plan is to give the first dose to as many as possible then follow up with a second dose within 12 weeks. This way as me any people as possible get some protection

 

That is the plan, yes, but is it a single dose vaccine (like the Johnson and Johnson one) or a two-dose vaccine? That was the question by the other user, and the answer is, it is a two-dose vaccine. The AstraZeneca vaccine, unlike the J&J one, was never studied as a single-dose one.

 

Two more pieces of vaccine news:

The US anticipates that emergency authorization for the AstraZeneca vaccine won't be possible before April 2021, when hopefully their American phase 3 study will conclude, given that the FDA is unlikely to approve the EUA while the controversy between half dose and full dose is not yet solved (big blunder by AstraZeneca, if you ask me - they should simply have invalidated the half-dose numbers as the mistake that it was, and reported only the full-dose result of 62% which is sufficient for an EUA (which only requires 50%); by being greedy and trying to use those numbers to average to some 70% they shot themselves in the foot - and appeared untrustworthy, spooking the FDA).

Sinopharm Beijing, one of the five Chinese vaccines in late phase, released today an efficacy number of 79.3%, in a 2-line statement with no other details. I'm not sure if I can trust this information, but to be complete and to keep readers of this thread informed of the latest developments, I'm reporting it here.

Just for a recap, Sinopharm has two vaccines; one by the Beijing branch which is the one that released results today, and one by the Wuhan branch, of which we have no info yet. The much smaller company Sinovac is a different one, and is the one involved with Brazil, Turkey, Indonesia, and Chile. China also has in late phase a vaccine by Cansino, and the latest comer, just starting their phase 3 this month in Uzbekistan, is a company called Anhui Zhifei Longcom Biopharmaceutical. Unlike the first four, this one is a recombinant subunit vaccine (similar to the Novavax one). They also plan to test it in Indonesia, Pakistan, and Ecuador.

 

Astra Ze has a similar problem with the EU. EMA requested more data.

 

Two points:
1. On radio phone ins we've already had listeners asking if they can refuse the Oxford vaccine and wait for the Pfizer vaccine to become available because of the higher success rate.

2. The vaccine companies were promised guaranteed payment for a fixed number of doses whether they passed the trials or not. Yet now we are waiting for the doses to become available. Why wasn't the production stepped up as soon as the later trials were started hence ensuring that the full purchase numbers would be available once vaccine was approved? Were there get out clauses in the purchase contracts

 

It takes several month to retool those factories. For mRNA vaccines you need bio reactors. There are not to many manufacturers in for those around.
bioNtech bought a factory from a Suisse pharma company in the city of Marburg. The deal was completed early December and is now retooling it. Pfizer retooled one of its factories in Belgium and is working on 3 in the US.
All 4 of those bio/pfizer factories should be fully operational by end of January.
Remember bioNtech was only a research lab and has already built a production line at its headquarters and is producing as much as possible. Naturally there is the supply line of the super high quality of ingrediency, which has to be ramped up. Than each new factory has to get certified, samples have to pulled and checked, etc. etc.

Pfizer got the snub from Warp Speed, concerning ingrediencies, political game

 

Are you in the UK? I suppose so because the US will not approve the Oxford vaccine before at least April. I think people should take whatever vaccine is available to them first. The sooner the better, given the new infectious strain, and possibility of further mutations. There is one VERY important factor to consider regarding the Oxford vaccine: nobody got serious Covid-19 and nobody died of it in the vaccinated arm of the trials. So even though it is less protective than the Moderna and the Pfizer ones for acute infection, it is protective against serious and fatal disease. So if Oxford/AstraZeneca is what is offered to you, take it.

Not true (at least not in the US). You may be mixing up R&D grants with advance purchase contracts. The former don't need to be repaid, but the latter are ONLY valid if/when the vaccine gets approved by the nation's regulators. At least, that's what was done here in the USA. I don't know about the UK.

It is extraordinary that we have vaccines, at all, less than 11 months after the virus was sequenced, and that they are already finding their way into people's arms, although the doses are still scarce. I think these companies are truly doing the best they can to ramp up production. But there are other issues, such as ingredients, and even glass vials. We can't accomplish miracles. People need to be a bit patient. We're all proceeding as fast as we can. Here in the US we got 14 million doses delivered but only about 3 million doses in people's arms. I had mine today. It was a long process with forms to fill, consents, disclosures, plus 15 minutes of observation to make sure I didn't have anaphylaxis. My organization is a bit behind in getting us all vaccinated (we have thousands of employees) but everybody is working hard to get it done. There is a learning curve involved in handling the Pfizer requirements (both paperwork-wise, and the deep cold handling), getting people signed up through the State Registry to make sure the right kind of people are getting the vaccine and people are not jumping the line, etc. We had to consult every employee because they're allowed to decline (unlike the flu shot, paradoxically). The intake person needs to check if the employee is registered, got the classification of priority tier 1a, accepted the disclosures, etc.

 

China has approved the Sinopharm Beijing vaccine for use by the general population.

 

The UK is playing with fire. They are talking about giving just the first shot so that they don't need to cut the number of vaccinated people in half. They are extending the 2nd dose wait period to 12 weeks and recommending mixing different vaccines. None of it has scientific evidence, yet. Desperation makes for impulsive action that results in mistakes.

https://www.yahoo.com/news/uk-covid-19-vaccine-recommendations-044003531.html

Pfizer has strongly spoken against what the UK is doing. No evidence that their vaccine protects beyond 21 days if the booster shot is not given. And while there is a study of mixing different vaccines, it hasn't concluded yet.

 

Don’t think they are recommending mixing vaccines, but they are starting a trial to look at the effect of mixing vaccines as there is a potential to have increased protection.

Don’t agree with them in delaying the Pfizer second does as this has not been tested, not sure about the Astra Zeneca vaccine but I think it’s up to 12 weeks.

I can see what they are trying to do with getting as many people as possible to have their first injection to provide some protection, around 70%.

 

I understand the reason for the strategy (getting some protection to more people) but I find it risky.

Yes, they are suggesting it: "The British government is suggesting that people could mix and match their two COVID-19 shots, if need be."

The AstraZeneca phase 3 study press release talked about the second dose "at least one month apart."

The Lancet study with their phase 3 in the UK, Brazil, and South Africa is here:

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32661-1/fulltext

The sites had slightly different methodology. You can see that the UK study got 4 weeks for the booster shot. In Brazil the "target" was 4 weeks but the second doses were given up to 12 weeks due to an amended protocol. All the subjects in South Africa were given a booster in 4 weeks.

The Phase 3 study in the United States schedules the second dose 4 weeks after the first one:

https://clinicaltrials.gov/ct2/show/NCT04516746

I don't think the Pfizer vaccine delivers 70% protection with one dose. We don't even know how long the protection is. We only know that at 21 days (the time of the second dose) protection is around 50%. It could fade without the booster. That's what I find risky.

As for the AstraZeneca, who knows? Their numbers were all over the place.

The AstraZeneca trial was incredibly messy (not only with the variable booster dose, but the blunder of the incorrect half-doses), which is why our FDA hasn't considered them yet. We want to see a clean American trial (the one I linked to above) before we consider approval.