Johnson & Johnson requests emergency use authorization of its COVID-19 vaccine

[Yo_Mama_Been_Loggin]

Source: The Hill

Johnson & Johnson on Thursday filed an application for emergency use authorization for its single-shot coronavirus vaccine, bringing it one step closer to helping the U.S. fight against the virus.

The next step is for the Food and Drug Administration (FDA) to convene a meeting of its vaccine advisory panel to review the evidence, which could happen in as little as two weeks.

In a statement the company said it "expects to have product available to ship immediately following authorization," but did not specify how much. It still expects to meet its commitment of supplying 100 million doses by the middle of the year.

"Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping. With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible," Paul Stoffels, Johnson & Johnson's vice chairman of the executive committee and chief scientific officer, said in a statement.

Read more: https://www.msn.com/en-us/news/us/johnson-and-johnson-requests-emergency-use-authorization-of-its-covid-19-vaccine/ar-BB1doLuj?li=BBnb7Kz

[Cicada]

1. Why will there be a 2 week delay for a meeting?

The evidence can be emailed to committee members today. Can’t they review it by Monday and meet by conference call on Monday?

[kirby]

8. It is not a rubber stamp...

The scientists and staff need to independently review all the data. You make it sound like a formality. The data could be wrong or misleading or not worthy of approval all. Who knows until reviewed.

[Cicada]

10. Why can't the outside science advisers act fast?

I know that the evidence must be carefully reviewed. That many outside experts must be given an opportunity to comment. But every day of delay causes deaths. Why can’t everyone involved stay up all night, work on it right now? Maybe they are doing that and it takes time for the drug company to create data the outside scientists ask for to check out possible problems. But if they are not working on it right now at full speed, all hands on deck, no time out for the weekend, I think they should change.

[WA-03 Democrat]

2. I like the single shot

Logistics of 2 shots is more than double the effort.

[LisaL]

3. It also appears very safe, with only minor side effects.

NT

[WA-03 Democrat]

5. I read that too

I think flu shots are going to be an unfortunate growth business.

Thanks dumb ass Trump.

[hamsterjill]

6. Needle phobes like me like that, too.

I am terrified of needles and cutting that fear in half is a positive for me.

[WA-03 Democrat]

7. I can stand them

I feel sorry for the people that have to do that job. I suck it up but I would scream at the top of my lungs if I could

[Liberty Belle]

14. Mom, who is 90 and terrified of needles, didn't even feel the shot!

She had a very good technician. I had her look at me and I started talking to distract her. Then the technician said "It's done!"

Mom looked shocked and said she didn't feel the needle at all. She was lucky and had no side effects at all, either.

I do know others who have had sore arms. Get some Arnica gel to have on hand in case of any bruising and swelling, but you'll probably be fine.

My daughter who is 32 has had both shots and didn't even have a sore arm.

[StarryNite]

15. I'm terrified of needles too.

I can't even watch them giving shots on the news. I have to look away. I don't know why they have to show it.

[hamsterjill]

16. I know. I don't like seeing it.

There is technology being developed for micro needles which is similar to transdermal patches. I sure wish there would be some forward development with that. It would make sense if people were able to vaccinate themselves. Plus, the stuff I’ve read indicates it’s cheaper.

[area51]

4. Get thee to the Greatest Page. n/t

[Baclava]

9. '72% Effective in the US and 66% Effective Overall at Preventing Moderate to Severe COVID-19'

'85% Effective Overall in Preventing Severe Disease and Demonstrated Complete Protection Against COVID-19 related Hospitalization and Death as of Day 28'

[Cicada]

12. I can live with head aches and nausea for 100% protection from death

Dr Fauci pointed out that 100% protection against serious problems and death is what matters, that mild or moderate illness is no biggie.

[Baclava]

13. Sounds good to me. Nothing is perfect. Just get me the damn shot, I'll be waiting

[roamer65]

17. I am having some of the joint pain and aches from the first shot of Moderna.

Two days out from the shot.

Still better than being dead or on a ventilator in an ICU.

It is definitely kicking my immune system into gear.

[roamer65]

11. I would take this vaccine if nothing else were available faster.

Some protection is better than none at all. Main goal is not to die or end up in a ICU.

Studies are commencing about receiving multiple vaccinations with differing manufacturers, so this J&J and then the Moderna or Pfizer later may be a plus.

If studies confirm it, I may enhance my Moderna vaccination with a shot of this one.

[riversedge]

18. k and R