ricardo00

There is a pandemic (duh) and more people are dying everyday. What is the FDA doing?

Longshadow Loc: Audubon, PA, United States

The FDA works differently than its counterpart in England?
Just a guess.

robertjerl Loc: Corona, California

Doing its best to worship at the altar of bureaucracy and regulations.

You wouldn't want any reports to only be done twice and in only two copies instead of 20 would you? Or any "T's" to go uncrossed or "i's" to not be dotted!!!

robertjerl Loc: Corona, California

The FDA works? Who knew?

Longshadow Loc: Audubon, PA, United States

Yea, I wasn't sure if I was being facetious or not.....

Frank T Loc: New York, NY

Our elected officials are waiting for the checks to clear from the lobbyists.
Then we can move forward.

Longshadow Loc: Audubon, PA, United States

UTMike Loc: South Jordan, UT

Congress writes the rules that the FDA must follow. Remember thalidomide?

ricardo00

I just don't understand how they can take 3 weeks to decide whether to let people (primarily healthcare workers who are getting exposed on a daily basis to COVID) choose to get a shot that will give them 95% protection with minimal to no side-effects. What is there to debate?

UTMike Loc: South Jordan, UT

I am not picking a fight with you, but there is a long record of drug companies making claims (particularly about things that will make them money) and then being proved wrong. It took everyone (Republicans and Democrats) several months to even acknowledge the depth of the problem, let's get the solution correct. Didn't you notice that Astra-Zeneca, in a rush to the money, has had to redo its studies?

ricardo00

During ordinary times, I would agree with you. However 2,500 people are dying everyday and the number of new cases and deaths is still rising. The FDA can't "prove something wrong", they can only look at the data and make a decision. Once you have access to the data (which occurred in mid-Nov), how long does it take you to sift through the data and draw a conclusion? I would think that they would try to do this as rapidly as possible.
Yep drug companies are in it to make money (as well as grab bragging rights) and have an incentive to rush the studies through. However, in this case, it works to our benefit. Astra-Zeneca screwed up (some people received half dosages) and, more surprising, these people had more benefit than those receiving a full dose, which is why they will have to add more patients in this group. Since if the protection is only 70% (as the larger group which received the higher dose) showed, this vaccine is not as good as the others.
And if I was Pfizer and the vaccine was approved in other countries, I would send it there instead of waiting for another place that hadn't approved it since as you stated, they are in it for the money.

robertjerl Loc: Corona, California

Congress passes laws. The agency writes its own regulations and procedures to implement them. And each office in that agency then proceeds to build their own little empire to follow those regulations, write those reports etc. The more steps and the longer the time = more paperwork = more employees = bigger empire and the higher the salary of the head of said mini-empire for supervising more people.

Haenzel Loc: South Holland, The Netherlands

The UK is dealing with a very bad economy due to the pandemic. On top of this an even more severe threat to the economy is on the horizon: Brexit. Christmas is economically very important, so the lockdown needs to go asap trying to turn the tide.

What could play a role as well is Boris Johnson who wants to prove the UK is better of without EU regulations, hence the decision to prematurely accept the Pfizer vaccine....In Europe this is not possible yet.

I wish the UK and it's people all the best in these challenging times..

pendennis

We've learned the hard way, that the testing procedures on drugs in other countries, can be less than stellar, even in "Merry Olde England". We've also learned that abandonment of effective drugs, owing to inept and sloppy lab work is also a problem. There's a drug used for morning sickness by pregnant women, by the name of Bendectin. It's a relatively mild antihistamine. My wife took it during her pregnancy with our younger son. Unfortunately, he was born with a bilateral cleft palate and lip in 1975, and around 1980 we investigated the possibility of joining one of several class action lawsuits against then Merrill Dow Pharmaceuticals. They had pulled the drug based on lawsuits, and the later-debunked, flawed study by the same doctor who found Thalidomide to cause birth defects. It seems he needed another "winner".

It works both ways.

And yes, folks are dying every day from the effects of COVID-19. Those same folks died of some type of organ system failure, and the fact that folks had COVID-19 infections, does not mean that COVID-19 was the secondary cause of death. There isn't necessarily a cause-and-effect connection.

And don't forget, for-profit corporations are always "in it for the money". That's why they're in business.

ricardo00

Not sure what economic indicators you are looking at (other than the stock market), but things are pretty bad here in the US with unemployment sky high and small businesses closing at a record pace. And Christmas (though not Boxing day) is very important here as well though with online purchases in both countries this is less of an issue than the closing of restaurants and the tourist industry (including airlines), etc. Of course these issues are nothing compared to much less developed countries.