The state of the vaccines

The J&J vaccine got 22 yesses, 0 noes, and 0 abstentions. Approved, with a score better than the Pfizer's and the Moderna's.

 

How does the Johnson & Johnson vaccine compare to other coronavirus vaccines? 4 questions answered
Charles Rotter
The adenovirus vector vaccine is safe because the adenovirus can’t replicate in human cells or cause disease, and the SARS-CoV-2 spike protein can’t cause COVID–19 without the rest of the…

 

As you all know, the FDA issued yesterday the EUA for the Johnson & Johnson vaccine. Like I said before, it can only get into people's arms after the CDC also approves it. The CDC's committee is meeting today and tomorrow to issue a recommendation to the agency's director, so it is likely that the CDC committee will approve it by tomorrow and on Tuesday the head of the CDC, Dr. Walensky, will approve it too, so that it can start getting into people's arms on Wednesday. The company has 4 million doses for immediate shipping and will supply 16 million more by the end of March and 80 million more by the end of June, to complete the 100 million ordered by the US government. Given that this is a one-shot vaccine, it will protect 100 million Americans.

This vaccine is less efficacious than the Moderna and the Pfizer in preventing mild and moderate disease, but it is as efficacious as the other two in preventing what matters: hospitalizations and deaths. It is also less reactogenic with fewer side effects.

And like Jack Hays said above, it is perfectly safe. The adenovirus vector that it uses to deliver the genetic material is non-replicating. It is able to enter the human cells to deliver the cDNA that will teach the cell how to make the virus' spike protein so that the body makes antibodies against the spike protein (much like the mRNA vaccines by Moderna and Pfizer do, but using a slightly different mechanism), but it is not able to reproduce. Even if it were, adenoviruses are benign viruses that at most cause the common cold. The vaccine doesn't cause the common cold. The adenovirus it contains, just delivers the cDNA to the human cells and does nothing else. Oh, and don't pay attention to conspiracy theorists who say that this vaccine will alter human DNA. It does no such thing.

Given that this one-shot vaccine that withstands regular fridge temperatures is very efficacious to prevent hospitalizations and deaths (if I'm not mistaken no cases of critical illness anywhere - including in South Africa and Brazil - has happened among people vaccinated with the J&J vaccine), it is a welcome addition to our arsenal against the SARS-CoV-2.

If you are given the opportunity to take this vaccine, get it immediately. Don't hold back trying to wait for an opportunity to get the Pfizer or the Moderna. While these two indeed are more efficacious to prevent mild and moderate cases, it is way more important to prevent hospitalizations and deaths and the J&J does this part beautifully. Also, do realize that Pfizer's and Moderna's efficacy data were obtained when there weren't any variants around, unlike J&J, so, we don't even know if the numbers for Pfizer and Moderna would have dropped some, if they got tested against the same variants the J&J was tested against.

The bottom line is, all three vaccines are safe and effective. Get the first one that is offered to you, with no hesitation.

 

By the way, if you are curious, cDNA is complementary DNA, which is a double-strain DNA that we make by reverse transcribing mRNA. The cDNA delivered by the vaccine enters the host's nucleus where it can be read to make mRNA which then goes back to to cell's cytoplasm to make the spike protein. So, the end result is the same as the Moderna and Pfizer vaccines: the mRNA that will make the S protein gets to the cell's cytoplasm; it's just that the mRNA vaccines do it directly, while the cDNA vaccines have an additional step before the mRNA is delivered to the cytoplasm. Why? Because placing the genetic material as cDNA inside an adenovirus, makes it more stable and resilient, which is why the J&J vaccine doesn't need to be stored in a freezer.

This article explains beautifully how the J&J vaccine works, with nice drawings:

https://www.nytimes.com/interactive/2020/health/johnson-johnson-covid-19-vaccine.html

 

The CDC panel on the J&J vaccine has voted today: approved, 12-0-1 (one abstention due to conflict of interest). No restrictions, just 18 years old and up.
The CDC director has approved the committee's recommendation. That was the final step.
The J&J vaccine is now officially approved and available to Americans, effective immediately.
The first shipments will leave the facility tonight or tomorrow morning.
I'm very excited. The fact that it is a one-shot vaccine and it only requires refrigerator temperature makes of this new vaccine a huge game-changer.

 

I have a question if anyone doesn't mind. Do they send one or all of the manufacturers' vaccines to an area? In other words, will I get to choose which one I get or not?

 

In my hospital, we got both Pfizer and Moderna. We haven't received any J&J yet. We do expect to receive some J&J in the future. Currently we have used all of our Pfizer stock. This coming week we're getting another Moderna shipment. We've been offering the vaccine to staff and patients, without a choice regarding the brand. The only choice is, accept the vaccine or decline. We hold a vaccine clinic with one of them, and whoever has appointments that day, gets the one we're dispensing that day. Once we have a large surplus then people will likely be able to choose. As of now while the vaccines are still relatively scarce, this choice has not materialized yet. Like I said before, just get the first one that is offered to you, ASAP. All three are very protective against hospitalization and death.

 

Thanks for clarifying this.

 

@MJ Davies read this article, it's a very good one highlighting the efficacy of these vaccines. Also do know that the J&J is less reactogenic and causes fewer side effects.

https://www.yahoo.com/huffpost/can-you-choose-which-covid-vaccine-150809680.html

 

I will check it out. Thanks!

 

I read the article. My understanding (admittedly, limited on this subject) is that a person can experience long-term health problems related to the lungs, heart, etc. regardless of the severity of COVID symptoms. Is this inaccurate?

From the article...

I am also concerned about the J&J vaccine because they are testing on newborns.

Beyond that, I'm concerned about the number of recalls J&J has for various products.

Any light you can shed on this is much appreciated.

 

People who survive severe cases of Covid-19 do tend to have more complications such as pulmonary fibrosis. But yes, there's been numerous cases of myocarditis, blood clots, etc., in people who only had mild or even asymptomatic Covid-19. I've been warning about this forever and ever, that Covid-19 is more dangerous than people think when they only look at death rates. So, yes, the article wasn't especially accurate regarding this part. Good catch.

I'm not experienced in Pediatrics and Neonatology. I don't know what to say. What I can tell you is that Covid-19 did cause some serious cases of MIS-C in children. Some died. But yes, it is rare.

Most of what you are quoting above comes from the consumer products division and the health devices division. Vaccines come from Janssen, which is Johnson and Johnson's pharmaceutical branch that is totally separated from the others. Sure, some stuff you mentioned above does regard medications... but in this case, we should be glad that Merck will be manufacturing most of J&J's vaccines. Merck is a vaccine giant... but they were unable to come up with a viable Covid-19 vaccine, so now they've joined the effort by helping with production of the vaccine using J&J's recipe.

 

The CoronaVac vaccine concluded its phase 3 trial in Turkey with 10,261 participants.
Pretty good final results:
83.5% efficacy based on infections that had at least one symptom
100% efficacy to prevent hospitalizations and deaths
No serious side effects

Turkey has already administered about 9.32 million doses of the CoronaVac to its population, outside of the trial, and they did not register a single case of serious side effects either.

So the CoronaVac seems pretty efficacious and very safe. It is a 2-shot vaccine, with the second shot between 3 and 4 weeks after the first one, and it does not require freezer temperatures. So, it seems like a good option for the developing world.

 

Brazil has finally closed a deal with Pfizer. They are purchasing 100 million doses. It's total capitulation because Pfizer did not budge regarding the Brazilian's objection to the clause about no liability. Pfizer said it's standard clause, that all countries have agreed to. The Brazilians didn't want to buy it with this clause... but now that P.1 is overwhelming the country, major cities are going back into lockdown, and the healthcare system is close to collapse, and all that they have is a limited number of CoronaVac, and the less efficacious AstraZeneca (especially against new variants), they capitulated and accepted Pfizer's conditions.

The idiotic Brazilian president should have accepted these conditions and should have purchased these vaccines long ago, when Pfizer first offered (months ago).

 

Canada will extend the interval between the two doses of Moderna and Pfizer to 4 months, in order to give the first dose to more people.

I say, big mistake.

I am so glad that I have already received my two doses, in case this boneheaded decision ends up on this side of the border too... although now that we are supposed to have more than enough vaccines by the end of May, I don't think that this will happen in America.

 

India's Covaxin finally got efficacy data: 81% in interim analyses, phase 3. There will be two more analyses until phase 3 is complete but at least there is this good news, finally. Some countries have been already purchasing the Covaxin without any efficacy data whatsoever. Fortunately, the preliminary data are encouraging.

 

New evidence that the P.1 escapes vaccines (a small - but well done - study using plasma from 8 individuals vaccinated with the CoronaVac, and like I said - and the authors also highlight - there is still cellular immunity). Still not peer-reviewed, submitted to The Lancet.

https://static.poder360.com.br/2021...riante-manaus-coronavac-lancet-1-mar-2021.pdf

"Here, we described a loss of neutralization capacity of at least 6-fold in plasma from COVID-19 convalescent patients against isolates of P.1"
"these results suggest that P.1 virus might escape from neutralizing antibodies induced by an inactivated 304 SARS-CoV-2 vaccine (i.e., CoronaVac)"
"Moreover, five months after booster immunization with CoronaVac, plasma from vaccinated individuals failed to efficiently neutralize P.1 lineage isolates."

They used both convalescent plasma, and plasma from vaccinated individuals. Observe that five months might be pushing the limit of response. Still, a 6-fold antibody drop exceeds the 4-fold threshold usually utilized to indicate that a flu vaccine needs to be updated to new strains. It is becoming clearer that as expected, variants-updated boosters will be needed. Again, we are involved in a race vaccines vs. mutations.

This study does have limitations, the biggest one being that the neutralization was small for both the P.1 and the B (ancestral) variants and near the detection limit of the VNT50 assay used in the study (1:20). So, the P.1 fell below the threshold (<20) and the B hovered above it (25) but there was insufficient statistical power given the low number of samples (.

Also let's not forget that the CoronaVac has demonstrated weaker immunogenicity than the BNT162b2 (the Pfizer/BioNTech vaccine) so we can't assume that these lousy CoronaVac results indicate that the Pfizer will be just as lousy.

Still, limitations or not, I find these results concerning, especially because for now, in Brazil, all that they have is a limited quantity of CoronaVac and AstraZeneca (the latter has also demonstrated low efficacy against new strains). And they have a huge outbreak there. It doesn't bode well for their capacity to contain it, and we know that the more out of control an outbreak is, the more it generates mutations and even newer variants. Brazil has finally made a deal with Pfizer and they are making another one with Moderna, but deliveries will be months ahead since by now the production capacity of these companies is spoken for, to honor earlier contracts with other countries.

So I'm afraid that the Brazilian outbreak will come back to bite other countries.

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On another news, regulators from the UK, Australia, Canada, Singapore, and New Zealand have indicated that they will fast-track variants-updated boosters manufactured by the makers of currently approved vaccines, a smart move. To expedite the battle against the new variants, we need updated vaccines as soon as possible.

 

Everybody talks about the dead, but nobody of the survivors, who will have to live for decades with the damage the virus has done.
Friends in Europe had Covid, mid 40s. She works in a Covid ward, brought it home. That was in June, none of them had to be hospitalized.
Today, both still have to use oxygen, she has to use a inhaler at least once a day. Both are back to work, but they are just at 50% of their pre Covid capacity. Both have when stressed to much brain fog.
The dead are dead, that is final, sad, but we will have millions of survivors, who will be for the rest of their live damaged and with a shortened live span.

That is the real tragedy of Covid.

 

This is a real tragedy and one that needs to be considered. It's hard to know who will develop the long-term complications and reduced life span and quality of life so it's frustrating to hear people throw out statistics of the probability of dying is so low or say it's like the flu. It's clearly something more than that.

I'm sorry about your friends. I lost two family members to COVID. One literally dropped dead. His mom passed two weeks later. Heartbreaking.

 

This is what I do not get.
Yes I am at time brutal pragmatic. Dead is dead, its final, its sad and traumatic for the family.

The survivors continue to live and millions with sever disabilities.
What will that do to our society. Just think of what a problem that will be to our health systems, world wide.
Can they function like me, at 66, if they have brain fog with 45. Will they have dementia starting at 60, or Alz.
How about their damaged organs, lungs, kidneys, heart, liver and lung. Will they fail earlier ?
Will they get those cancers earlier.

It is this wrong perception, its just the flue. What we do not recognize, that even mild cases can have serious health consequences, especially for the younger.
This is what needs to become head line.


I am very sorry for your losses. My heart goes out to you.

 

Exactly. I've been talking forever of the long-term consequences of Covid-19 including for young and healthy people. It is incredible how people only focus on the death toll, without realizing how nasty this virus is. And yes, I've been also mentioning the economic impact that the sequelae will have, several times bigger than whatever economic damage happened from the containment measures.

 

This thread needs a bit of humor

 

I heard recently an interesting thing regarding long covid. The people mainly effected by this were those that had mild symptoms but attempted to battle through it by trying to carry on as normal instead of resting completely for two weeks. I wonder if there has been a study on this. I know if I got the virus I would be one of those who would want to carry on with my exercises such as cycling outdoors and indoor general training, but perhaps I would reconsider given what I heard

 

https://www.yahoo.com/news/exclusive-oxford-study-indicates-astrazeneca-143120820.html

Seems like the AstraZeneca that performed poorly against the B.1.351 (South African) variant, is better against the P.1 (Brazilian) variant. I haven't read the study itself which hasn't been released, so I can only offer this lay-journalist article. If true (often lay journalists misinterpret studies), it will be good news.

 

I don't know, seems anecdotal to me. I haven't seen a study and I don't know one way or the other.