The state of the vaccines

Two interesting pieces of vaccine news:

The Johnson & Johnson adenovirus vector vaccine which is very exciting because it is single dose and doesn't require freezers, supposedly will have concluded its phase 3 on January 21st and will apply for EUA immediately thereafter. Fingers crossed; could be a huge game changer.

The CoronaVac had more detailed efficacy data from Brazil, and it is disappointing in some ways but encouraging in some other ways. It's the only maker that has released data stratified like this, so it's a different concept. Here is what it is:

The vaccine is only effective at a rate of 50.38% in preventing infection by the SARS-CoV-2, including, asymptomatic infection, a.k.a. cases of infection with no symptoms whatsoever.
The vaccine is effective at a rate of 78% in preventing cases of Covid-19 that have mild symptoms, so 12% of vaccinated people may still acquire mildly symptomatic Covid-19.
The vaccine is effective at a rate of 100% in preventing cases of Covid-19 that have moderate or severe symptoms, hospitalizations, and death,

So, the bottom line is, the CoronaVac does a lousy job preventing infection, which might result in carriers of the virus still passing it on to non-vaccinated others. But it does a spectacular job in preventing moderate or severe symptoms, so that anybody who takes this vaccine will at worst have a mild case of Covid-19, won't need to be admitted to a hospital, and won't die.

This, while worse than Moderna and Pfizer (which prevented infection about 95% of the time) may be just good enough for what really matters, that is, avoiding the moderate, severe, and fatal cases of the disease.

It is to be noticed that in Pfizer's trial, one vaccinated patient did have a severe case of Covid-19 (did not die). In the Moderna trial, no vaccinated patient had a severe case.

Anyway, the CoronaVac seems to be less good, but still good enough to be very helpful.

 

Is there any information on whether any of these vaccines prevent the known long term effects of infection?
Do the long term effects occur in non symptomatic or mild symptom cases or only in the more serious cases?

 

EMA now allows 6 shots to be drawn out of a vial with bioNtech vaccine.
With new production plants coming online, bioNtech and Pfizer have updated their production forecast to 1.5 billion shot for 2021.
BioNtech predicts its second generation shot will be out middle of the year, it will allow storage at around 40 degrees F.

Curevac and Bayer have signed a cooperation contract. It is expect that Curevac will have finished Phase 3 end of March. Its mRNA can be stored at 40 F.

 

In Italy today Moderna vaccine has arrived. Good.

As an aside note, EU is looking for a deal with the Russians for the Sputnik vaccine [I wonder if the collateral effect of that vaccine is that you "fly" to the space like after smoking marijuana ...]. We will discover this soon.

https://www.cnbc.com/2021/01/07/covid-vaccine-merkel-open-to-producing-russia-sputnik-in-the-eu.html

 

No, no information that I know of, given that the follow up for the vaccines was set at just 2 months for the Emergency Use Authorization (usually, 6 months are required) due to how urgent the pandemic is. Yes, some studies have shown even asymptomatic survivors of an infection with the SARS-CoV-2 to surprisingly still have suffered damage such as inflammatory myocarditis.

 

That is interesting, given that I have never fully trusted the data about the Sputinik V. Maybe I was wrong and it is good, after all. Certainly the Germans are very reliable, and if they endorse it, it must be more solid than I assumed.
LOL for the flying trip...

 

In that case a vaccine which only results in 50% immunity is not so great even if it stops you getting a serious case or death. In comparison to other vaccines, not no vaccine at all obviously.
I would not be happy if that was the one I was offered.

 

Yeah, which is why I said that the Coronavac "seems to be less good." Fortunately my wife and I got the Pfizer. But the way the situation is dire in Brazil, and given that they are set up to make the Coronavac on site, independently, it will still be a great resource for them. But it wouldn't have much traction here. I think the Coronavac will be the vaccine of the Third World... but will be shunned in more developed countries.

 

Also, and not trying to find fault here, your maths seems to be out.
I point this out only for clarity not nit picking. Is it the 12% or the 78% you got wrong? I assume the 12% but want to be sure.

 

Russia has issued an EUA for their second domestically-made vaccine, the EpiVacCorona (made by FBRI/VECTOR) – a peptide-based vaccine. They have already started using it to inoculate the population. It seems like the Russians couldn't care less for phase 3 trials...

 

Oops, yes, meant to be 22%. 78% is correct.

 

As an aside note, in Italy we have bet a lot on the vaccine which will come from Johnson & Johnson.
It will be the decisive weapon in second trimester, waiting for the Italian vaccine [which will be ready on late like everything Italian ...].

 

Yes, the J&J data is imminent and if good, it will be a game changer given that it is a one-dose vaccine.
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Today, Turkey became the second country (after Indonesia) to approve the CoronaVac. They quoted 65% general efficacy. They have arranged to purchase 50 million doses from the Chinese.

 

The matter of the double dose can be a problem in these early phases. There is a temporal limit to get the second jab. And we are in winter. If it snows a lot some areas of Northern Italy can suffer of serious problems about transport. This is why in the North we are not using all the doses immediately, creating a bit of escort.
We have already known a delay about some supplies because of weather conditions.

A one dose vaccine [like the J&J] would avoid this kind of risk. And obviously it would reduce the logistic problems connected with a double mass vaccination: you don't have to vaccinate 60,500,000 Italians, but actually you have to use 121,000,000 of jabs.

Not only this: we don't know yet with accuracy the duration of the immunization generated by these vaccines [simply because there hasn't been time to discover this]. If they are seasonal, in July we will have to vaccinate again who has been vaccinated in January ... [while the mass vaccination will be still in progress]. To have a one dose vaccine would reduce the mess ...

Personally I tend to be ready, so that I start from the idea that the immunization will be seasonal. If in reality it will last for longer ... we will be very happy. But it's better to be in the conditions to manage an eventual second wave of mass vaccination while the first one is in progress.

 

Status of approvals around the world:

1. Sputinik V - (Russia, Argentina and Belarus)
2. Sinopharm Beijing (China)
3. Moderna - (USA, UK, Canada, and Israel)
4. CanSino - (China - limited use for the military only)
5. Vector - (Russia)
6. Sinopharm Wuhan (China and UAE)
7. Coronavac - (China, Turkey, and Indonésia)
8. Pfizer- (USA, Chile, Costa Rica, UAE, Kuwait, Ecuador, Mexico, Panama, Isarel, Singapore, Bahrein, Colombia, Argentina, European Union, Canada, Saudi Arabia)

 

ANVISA, the Brazilian FDA, has rejected the Sputinik V's EUA. Tomorrow, Sunday 1/17, they will rule on EUAs for Oxford/AstraZeneca and the CoronaVac.

The Sputinik V has been approved for use in Russia, Argentina, Belarus, Bolivia, Algeria, Serbia, and Palestine. But not Brazil.

 

When the Vacs become available for the general public, which one is best for Americans if we could choose : Moderna or Pfizer?

 

I slightly favor Moderna for two reasons: bigger dose (could be more robust in immunogenicity although there is also a downside to this, in the fact that Moderna's seems to cause more side effects that Pfizer's - hardly dangerous though, except in very rare cases) and it's more guaranteed that the cold chain wasn't broken given that the requirements for Moderna are less demanding. As far as I know, vaccine clinics are doing a good job with preserving Pfizer's deep cold requirements but one never knows if some local accident will go undiagnosed and someone will receive shots of the Pfizer vaccine that are less effective due to the storage temperature having been less than ideal.

Also, there is some data indicating that Moderna's first dose already results in some 90% of immunity after a couple of weeks, with the second dose bumping it up to 94.1%, while Pfizer's first dose may raise it up to some point between 50% and 82% (while Pfizer's second dose does bump it up to 95% - the reason for this large range is that Pfizer included in its analysis, data from the first week after the first dose so this may have artificially brought down the numbers to this 50% given that you don't have immunity during the first week, but some secondary data analysis does suggest that if you exclude the first 12 days and only consider data from day 13th through 21th, you do see some 80%). In this time of uncertainty regarding whether or not someone will receive the second dose timely, it might be a more sure thing to receive Moderna as one's first dose.

This said, both vaccines are fine and amazingly efficacious. I wouldn't hesitate in getting either if only one is available to you. I mean, I wouldn't refuse one in the hope of getting the other one later. Just get as soon as possible the first one that is available to you. But if you are truly given the choice between Pfizer and Moderna to be received the same day (meaning, you go to a vaccination clinic and they say "we have both here for immediate inoculation; do you want the Pfizer or the Moderna?"), then I'd recommend picking Moderna. Again, that I know, clinics are not allowing people to pick and choose. At least, not in my hospital. We have both, but given dose management and our attempt to maximize doses without wasting any, whoever shoes up gets what we give the person, not what the person might want to choose. The only option we give to our employees who are getting vaccinated, is whether or not they want a Covid-19 vaccine. If they say yes, we give them whatever is being used at the time of their appointment.

 

The end of a long soap opera: Brazil's ANVISA has approved the CoronaVac and the Oxford/AstraZeneca vaccines.
After much delay due to the anti-vaxxer moron who is that country's president, vaccination in Brazil will start as soon as tomorrow.

 

Brazil actually didn't wait for Monday. They started vaccination minutes after ANVISA issued the approval. A 54-year-old female nurse in São Paulo was the first person vaccinated after the approval, with the CoronaVac. João Doria, the governor of São Paulo and front runner as the main opposition presidential candidate for 2022, won the war against anti-vaxxer president Jair Bolsonaro. This will likely give Doria a lot of momentum in the presidential race.

 

Thousands of Vaccines Wind Up in Garbage Because of Govt Guidelines

 

OK, the CDC said that by March the more infectious B.1.1.7 strain will be the dominant strain in the United States.

https://www.cdc.gov/mmwr/volumes/70/wr/mm7003e2.htm?s_cid=mm7003e2_w

As of yesterday, it had been found in 15 states:

Utah, New Mexico, Nebraska, Wisconsin, Maryland, Indiana, Minnesota, Connecticut, Texas, Pennsylvania, Georgia, New York, Florida, California, and Colorado.

https://bestlifeonline.com/new-covid-strain-states/

In some other regions of the world, we've seen this strain getting from one case to dominant status in three weeks. It is about 56% more contagious. There is no evidence that it is more lethal or causes more serious disease, and there is evidence that both the Moderna and the Pfizer vaccine are protective against it. However, the concern is that since it spreads faster, it will contribute to overwhelming the healthcare system. Certain areas like Arizona are reaching capacity, and the new strain hasn't even be found in Arizona yet; when it gets there, Arizona will be in more trouble.

One big problem is that by now everybody is sick and tired of epidemiological precautions and prone to dropping them. It should be the opposite, since now we are facing an even more infectious virus. So we should become more careful, not less; but my hope for that is slim.

Given that epidemiological precautions are not very likely to stop this strain, what we need is faster rollout of the vaccines. We need to be vaccinating at least 1 million people per day, ideally 2 million, but we're vaccinating about 400,000 per day. More needs to be done. Get the National Guard involved, train more people to administer the vaccine, do a huge push in all levels (federal, state, county), get Moderna and Pfizer to produce more... And at this time I'd accelerate the approval process and issue an EUA for the Oxford/AstraZeneca vaccine.

We are in a race against the virus. Several reputable countries have approved the Oxford/AstraZeneca vaccine already. It is already being used in millions of people. Sure, the company botched their trial with the different dose strengths and the different intervals between doses 1 and 2, which caused the delay for the American approval: the FDA wants to see a new trial with standard doses and interval. But even if the efficacy is as low as 62% like in one of the AstraZeneca data sets (in all other data sets it's higher than that), it does seem that for the 48% that receive this vaccine but still catch the virus, the resulting illness is not serious or fatal and doesn't require hospitalization, so there is at least partial protection. We've approved flu vaccines with lower efficacy than 62%, and the FDA has established that 50% is the minimum threshold. So, get it done, FDA!

See, Oxford/AstraZeneca is the maker we contracted the most with, pre-ordering 300 million doses (while we pre-ordered only 100 million from Pfizer and Moderna each, initially).

So at this point and facing the rapid spread of the more infectious strain, we should be getting those 300 million Oxford/AstraZeneca doses. The FDA must speed this up.

This is terrible. Indeed, the guidelines were too complicated and restrictive. No vaccines should be going to waste because of guidelines.

Here is what guidelines should be: a suggestion. Follow them if possible, but if there is a surplus of vaccine about to lose validity and there are no takers around because of all these categories (1a, 1b, 1c, 2a, etc.) then give the vaccine to whoever wants it, dammit!

 

If you can, avoid NSAID drugs like Ibuprofen and others of its class at least two days before your Covid-19 vaccination. They can blunt the effect of the vaccines.

https://www.jimmunol.org/content/186/1_Supplement/45.18

http://www.ucihealth.org/covid-19/covid-vaccine-faq

If you take aspirin 81 mg to prevent cardiovascular events, you should continue.

Talk to your doctor about these drugs in advance of an appointment to have the Covid-19 vaccine.

 

Seems like about 1,300 participants of the Brazilian CoronaVac trial who received their second dose 3 weeks apart instead of the 2 weeks recommended by the protocol, had an efficacy of 70% rather than 50.4% for the 2-week group. Apparently the 2-week interval is too soon.

 

But the Feds could take some responsibility.
Another case of more is better.