[Arctic Fox]

Originally Posted by J1ceasar

6 months is fantastic but concider that the common Chinese flu has vaccines created every year in not much more time.

The annual flu vaccine is a generic, based on the previous year's, and has mixed results depending on how close it matches the actual virus. Since the flu shot varies little from the previous year's version, it is largely assumed that it will be safe to use.

That for Coronavirus has had to be designed from scratch. Not only does this take longer, but more testing is needed for safety before it can be generally released for use.

The major part of the "delay" in releasing drugs is the safety testing, and this is a trade-off between the risks and the benefits. Since the benefits of an effective Coronavirus vaccine are huge, it is considered worthwhile to take a bigger risk that there might be more adverse effects to its use, rather than spending years reducing this risk (and losing the benefits).

[noslices1]

Originally Posted by npwalters

I really don't have an opinion as to why the delay with the FDA panel. Still, given the depth of this crisis and the extraordinary measures taken by the manufactures and Operation Warp Speed to get a vaccine available, one has to wonder why not meet right away and get it done. I'm assuming that they did "rolling review" during the process like Britain did.

Moderna submitted their info to the FDA a week or so ago, but the FDA said they will meet and discuss their vaccine on December 10th. Haven’t they heard that we are in a PANDEMIC? What’s the holdup?

[jbrown132]

Originally Posted by Byte1

I read today that the Pfizer Covid 19 vaccine has been approved in the UK. Apparently, it can't be approved here until the panel (death panel?) meets later this month, so they can discuss whether or not it is safe for the U.S. I am sure that someone is going to post on here that they feel it is necessary for the wait. Sorry, but to me it sounds like the delay is political and not science when our leader demands that it be released and the powers that be smile and say it won't be allowed to be released until they say it can be released.

I wonder if those that consistently say that "other" countries are handling the virus better than us, will change their minds and begin to defend those that are hindering the release of the vaccine to the populace. Maybe those "important" folks that are holding it up under pretense of having a full calendar, are waiting for the death toll numbers to peak at a certain level?

I wonder if Pfizer being able to start distributing the vaccine overseas will impact the ability to provide sufficient amounts to the U.S. when the death panel finally meets and decides to allow our folks to obtain protection from the virus.

Just a few thoughts. Red tape and politics seem to be the norm in this country when it comes to any progress in pharmaceuticals.

It’s very clear that the FDA does no feel that time is of the essence. Their attitude is so what if another 50 or 100 thousand people die. Based on what I have been reading they knew back in September and early October that this vaccine worked. The phase three trial involved thousands more than they would normally have used in a trial of this nature so they new it’s efficacy rate was over 90%. Based on these facts one can only conclude that it is purely politics. Maybe other big pharmaceutical companies (big money) do not want it approved so they can catch up. Whatever the reason, it is embarrassing for a vaccine that was produced in this country to be approved in another country before it is approved here. The UK is not some backward country. They have excellent scientists there who would not release this if they thought it was a danger to their population. Let’s face it, we all know the reason but to keep this non political I will not mention it. Yesterday I heard that FDA can not meet until next week to discuss this. I mean there is only a pandemic going on so what’s the rush. This is pathetic, politics over lives, how sad.

[coconutmama]

Originally Posted by Cheapbas

The president “ demanding” the release is the scary part. This was batted around several months ago when people were hesitant to take the vaccine based on his words and actions. Let the folks who do the D & A part of the FDA do their job. I doubt the reviews scheduled for the 10th and 17th are due to vacation schedules. It’s scheduled there for a reason, it’s not a time for conspiracy theories

Totally agree. Not a time for conspiracy theories.

With a population of over 300 million in the USA, (over 21 million in FL) the vaccine coming in the next few weeks/months is a drop in the bucket, but a good start. Wear your mask & wash your hands in the meantime.

[merrymini]

People are dying everyday without covid 19. Remember thalidomide?

[JanetMM]

Originally Posted by Arctic Fox

Covid vaccine: What does UK vaccine approval mean for US? - BBC News

Thank you for that link. That article was very informative and answered many of the questions or comments that have been in this and other threads and articles.

Keep in mind that for a long time the FDA has often been slower to approve new meds than most European countries including the UK. This is something I have noticed for decades. I don’t know if that is good or if it’s bad but it really isn’t a political statement of THIS time period. It’s some thing that’s been happening for a long time.

Hope everyone stays safe.

[JanetMM]

Originally Posted by merrymini

People are dying everyday without covid 19. Remember thalidomide?

I think many pharmaceutical companies are afraid of rushing to vaccinate too quickly because the United States is such a litigious society. If they rush and it’s not tested enough and people die from the vaccine they will be sued by a lot of people if not even the government. The United Kingdom is not as litigious and so they can go through testing more quickly. The pharma companies are not in fear of multi billion dollar lawsuits.

The number of lawsuits after thalidomide just showed these companies they better test and test and test or they could pay the price.

[Villages Kahuna]

The reasons for the delay in the U.S. has been extensively explained in both newspapers as well as TV. The delay won’t be anywhere near as long as asserted by this poster.

THIS POST IS POLITICAL AND SHOULD BE REMOVED!

[Uncle Pepe]

I was told by someone that the reason the UK has the Pfizer vaccine first is that it was developed in cooperation with Oxford in England.

[dtennent]

Let's separate the press releases from a company from the actual technical data coming out of the research and trials. The FDA has a system whereby independent scientists review the submitted data which is not a trivial matter. Taking a few weeks for this process to run its course to ensure a safe and effective vaccine seems prudent to me. Yes I know that people are dying. However, in the past, people have suffered greatly when the process has been short circuited.

[Bonnevie]

I used to be a pharmaceutical sales rep. I can remember a drug, Oraflex, made by Eli Lilly. Approved in Britain before the US. had to be taken off the market less than a month after it was marketed. It had a host of side effects not seen until widespread use. Britain banned it first due the the side effects being seen. Seldane, an antihistamine only lasted about a year. there are many others. With the planned use in the entire population, I am glad they are taking every precaution in checking the findings.

[graciegirl]

Originally Posted by Bonnevie

I used to be a pharmaceutical sales rep. I can remember a drug, Oraflex, made by Eli Lilly. Approved in Britain before the US. had to be taken off the market less than a month after it was marketed. It had a host of side effects not seen until widespread use. Britain banned it first due the the side effects being seen. Seldane, an antihistamine only lasted about a year. there are many others. With the planned use in the entire population, I am glad they are taking every precaution in checking the findings.

I see your worthy debate on this. I, me, Grace Helene, an old woman with no degrees in science, have carefully, every day read about this vaccine journey, I read about it from valid sources in newspapers and I heard first hand from a person who was involved in the clinical trials and I watched when the trials were stopped and saw them start again and I know that Pfizer and Moderna have the ability to protect us more than 90% and Astra Zenica is lower, but more than 70%. I know that one vaccine was tested with more than 70,000 in the test group. Some got the vaccine and some got placebos.

I watched when people gathered here in a large group and wondered if infection would increase afterward and it appeared not to. I have had a million questions and tried to find the answers from science. I was very frustrated that there were so many to me foolish arguments and unfounded conspiracy figures.

I have tried to separate what is really happening from what people are telling us is happening.

I hope they get it here fast and refrigerate it carefully and that someone will invite us three to be vaccinated. Soon.

That is what I want for Christmas.

[Otis64]

Originally Posted by John41

It’s a fact that Operation Warp Speed provided incentives worldwide to produce a Covid 19 vaccine
and now there two available in record time. It’s a model of how to effectively deal with a pandemic and should be publicized not hidden away.

Pfizer said their quick development of a vaccine had nothing to do with Warp Speed. That sounds logical...It’s all about the BILLIONS of dollars world-wide to be made from getting out a vaccine to be sold across our planet!!!!!

[cherylncliff]

Originally Posted by npwalters

I really don't have an opinion as to why the delay with the FDA panel. Still, given the depth of this crisis and the extraordinary measures taken by the manufactures and Operation Warp Speed to get a vaccine available, one has to wonder why not meet right away and get it done. I'm assuming that they did "rolling review" during the process like Britain did.

Pfizer and their German partner are not part of Operation Warp Speed. They did not take any federal money but are self funded. The FDA has a legal responsibility to review and approve all drug marketing in the US to assure safety and efficacy.

[RoadToad]

Originally Posted by graciegirl

I heard on the local news yesterday that it would be released here on the fifteenth and today I heard from the same local news that it would be the tenth of December to Health workers and first responders and then to those in long term care.

The same news reported that Governor Desantis has a million doses on order for Florida.

A million doses for 21 million population. Hmmm ..