U.S. could start using one-shot Johnson & Johnson's 'game-changer' vaccine by February 2021 if it's approved, Operation Warp Speed chief says

Dawson County Journal ^ | 12/31/2020 | Valerie Edwards

[SeekAndFind]

A one-shot vaccine could be in use by February if Johnson & Johnson's jab is approved, according to Operation Warp Speed leader Dr Moncef Slaoui.

Slaoui on Wednesday said the Janssen vaccine could prove to be a 'game-changer' for the United States, which has recorded more than 19.7 million infections and at least 342,312 deaths.

According to Slaoui, Phase 3 trial recruitment for the vaccine has been completed and Johnson & Johnson is currently working with the Operation Warp Speed team to accelerate the availability of the vaccine doses.

'I think it can be quite a game-changer,' Slaoui told reporters. 'We're hopeful that this vaccine, which is a one-shot vaccine will have equivalent efficacy to those of Moderna and Pfizer.'

Single-dose shots would mean faster rollout, and that people would likely be protected from coronavirus in a matter of weeks after the injection - rather than the about one-month period it takes for Moderna or Pfizer's shots to reach their protective peak.

'I think it can be quite a game-changer,' Slaoui said. 'We're hopeful that this vaccine, which is a one-shot vaccine will have equivalent efficacy to those of Moderna and Pfizer.'

Both Moderna and Pfizer/BioNTech's vaccines require two doses and have more than 94% efficacy.

Slaoui also announced that the US is expected to approve the low-cost AstraZeneca/Oxford vaccine in April.

The Operation Warp Speed chief advisor, told reporters that US trials and assessments would be complete for approval 'sometime in early April'.

Several tens of millions of doses will have been manufactured... and therefore will be available for use if the data supports its approval,' he said.

He did not allege that Britain rushed its decision and praised Britain's MHRA regulatory agency as 'science-based'.

[SeekAndFind]

Earlier this month, Johnson & Johnson said it had enrolled about 45,000 participants for the first late-stage trial of its COVID-19 single-dose vaccine candidate and that it expects interim data by late-January.

[SeekAndFind]

HERE IS J&J’s PLAN:

The US has a contract with J&J for 100 million doses of its COVID-19 vaccine, with the option to buy another 200 million.

The enrollment of 45,000 participants in J&J’s trial means it can focus all its energy and resources on vaccinating and gathering data on trial participants

Now, it will face a waiting game.

A sufficient number of trial participants have to develop COVID-19 for J&J to assess whether there were significantly fewer cases among people who got the real vaccine, compared to the placebo.

J&J’s study, named Ensemble, is being conducted by its unit Janssen, the drugmaker said in a statement.

The company also confirmed that it plans to submit an emergency use authorization application to the US Food and Drug Administration (FDA) in February if the data from the study is safe and effective.

[dp0622]

Operation Warp Speed.

Never in history has such an incredibly successful leader lost a FAIR election.

But fair is a word for children. Few things are ever completely fair.

But there’s limits.

And when the limits are crossed, good men must make things right.

[Phillyred]

If anyone wants mine, you can have it.

[irishjuggler]

In the bizarro world in which we now live, I’m pretty much expecting British-American Tobacco’s vaccine to stun the public health world as the best of the lot.

[DesertRhino]

Well, their baby powder was pretty good.

[CatOwner]

And when the limits are crossed, good men must make things right.

Must but won't. Personal sacrifice for the country has been slowly bred out of our DNA (and diluted by ungrateful immigrants).

Oh sure, some will brag about what *they* will do when the time comes, whatever that is. But they will mostly be fighting alone or sparsely. A large majority of conservatives today would join that fight in spirit only.

[preacher]

L8r

[humblegunner]

I thought Johnson & Johnson was evil because some chicks
put baby powder on they coochies. Who told ‘em to do that anyway?

[odawg]

“But fair is a word for children.”

Usually accompanied with a whine.

“And when the limits are crossed, good men must make things right.”

All we have had so far is people stating and restating the problem. It is high time for action.

[guido911]

[\/\/ayne]

Does it alter dna?

[oh8eleven]

Personal sacrifice for the country ...
Non-existent. Gone. We've become "it's all about me ... me, me, me."
Compare that to the sacrifices made by Americans during WWII just two generations ago. Astonishing.

[ASOC]

Is sterility a listed side-effect?

I’ll wait for the antibody route for treatment....

[PIF]

Slaoui on Wednesday said the Janssen vaccine could prove to be a ‘game-changer’ for the United States, which has recorded more than 19.7 million infections and at least 342,312 deaths from the flu, vehicle accidents, suicides, drug overdoses, murders, etc

[wardamneagle]

What happened to the old sugar cube. lol

[steve86]

No, it doesn’t alter DNA and neither do the m-RNA vaccines. But fetal cell lines were used at every stage of J&J development, production and testing.

[Mom MD]

a little quicker maybe. Game changer - no. the first vaccines out are the game changer

[Mom MD]

None if the available vaccines alter DNA

[steve86]

So far, all known issues considered, Novavax’s vaccine is the only one I’d consider, but it isn’t available yet outside Phase III trials.