Q&A: Where are we in the COVID-19 vaccine race?

[snoop1130]

Q&A: Where are we in the COVID-19 vaccine race?

By Carl O'Donnell

 

FILE PHOTO: A woman holds a small bottle labeled with a "Vaccine COVID-19" sticker and a medical syringe in this illustration taken April 10, 2020. REUTERS/Dado Ruvic/File Photo

 

NEW YORK (Reuters) - Drugmakers and research centers around the world are working on COVID-19 vaccines, with large global trials of several of the candidates involving tens of thousands of participants well underway.

 

As some companies close in on unveiling their initial findings - with Canadian and European regulators already reviewing early data on some vaccines - the following is what we know about the race to deliver vaccines to help end the coronavirus pandemic that has claimed over a million lives:

 

Who is furthest along?

 

U.S. drugmaker Pfizer Inc with German partner BioNTech SE, U.S. biotech Moderna Inc and Britain-based AstraZeneca Plc  in conjunction with University of Oxford researchers could provide early analyses of data from their various large trials over the next two months. Johnson & Johnson is not far behind.

 

What happens in these trials?

 

The companies are testing their vaccines against a placebo - typically saline solution - in healthy volunteers to see if the rate of COVID-19 infection among those who got the vaccine is significantly lower than in those who received the dummy shot. Neither trial participants nor researchers know who has received the vaccine or placebo until the data is ready for review, or unblinded. The studies rely on subjects becoming naturally infected with COVID-19, so how long it takes to generate results largely depends on how pervasive the virus is where the trials are being conducted. In areas with large outbreaks and community spread, infections will pile up faster.

 

How will we know if the vaccine works?

 

The United States, the European Union, the United Kingdom and the World Health Organization have all set similar minimum standards for effectiveness. Vaccines must demonstrate at least 50% efficacy - meaning at least twice as many infections among volunteers who got a placebo than in the vaccine group. Independent panels oversee the trials to monitor for safety and effectiveness since the data is hidden from companies and researchers. These data safety monitoring boards take a peek at the interim results at pre-determined milestones, such as after a certain number of people have become infected. It the vaccine is looking significantly better than the placebo, the companies can apply for emergency use, and the study may be halted or continue to its intended conclusion. A trial also can be halted if the panel determines the vaccine to be unsafe.

 

Will regulators ensure a vaccine is safe before making it available to the public?

 

The U.S. Food and Drug Administration has said it will not approve a vaccine unless it is both effective and safe. On Tuesday, it added more stringent safety guidelines for U.S. vaccines. The FDA wants developers to follow trial subjects for at least two months after they receive their final vaccine dose to check for any side effects that may crop up. The agency will consider an emergency use authorization (EUA) once that data is collected from at least half of the trial's participants. The UK Medicines and Healthcare products Regulatory Agency will review the vaccines for the U.K. and the European Medicines Agency will review vaccines for European Union use.

 

When will regulators decide?

 

Regulators will review the vaccines after the companies have enough data to submit applications seeking an EUA or formal approval. Pfizer/BioNtech will likely know how well its vaccine works as soon as this month, while Moderna’s first look at data is more likely to come next month. AstraZeneca could provide a look at late-stage data in the next two months. Regulators for Europe and Canada are considering data on a rolling basis, as it becomes available. The U.K. and the U.S. both expect speedy reviews of initial data for possible emergency use before more traditional lengthy reviews for formal commercial approvals.

 

Could these be the first approved coronavirus vaccines?

 

Yes, although China and Russia are on a similar timeline. China launched an emergency use program in July aimed at essential workers and others at high risk of infection that has vaccinated hundreds of thousands of people. At least four vaccines are far along including from China National Biotec Group (CNBG), CanSino Biologics and Sinovac. Sinovac and CNBG have said to expect early trial data as soon as November. Russia’s Gamaleya Institute has begun a 40,000-person late-stage trial and is expected to have early data at the end of October or early November. Russia has also given the vaccine to at least hundreds of “high-risk” members of the general population.

 

Is U.S. authorization up to President Trump?

 

The FDA must make sure that the benefits of a vaccine outweigh the risks before authorization since they are intended to be given to hundreds of millions of healthy people. However, the U.S. Department of Health and Human Services (HHS) has the authority to override the FDA's recommendation. U.S. President Donald Trump has complained about the new safety guidelines that would likely delay any vaccine availability until after the Nov. 3 presidential election. The Trump administration can hire and fire HHS officials, opening the possibility of political pressure to approve a vaccine.

 

-- © Copyright Reuters 2020-10-07

 

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[JimHuaHin]

There are 16 types of coronavirus, 5 are to be found in humans, none have a vaccine.

[sawadee1947]

4 hours ago, JimHuaHin said:

There are 16 types of coronavirus, 5 are to be found in humans, none have a vaccine.

And your point is ???? 

[Airbagwill]

RACE??

 

Any medication has to go through trials (double blind etc) and then a peer review..

This takes time.

So what is most worrying is it is considered race when in actual fact this is a Hare and Tortoise situation.

 

It may be that we end up with a second-rate vaccine rather than the best one for political reasons.

 

The methods for verifying are laid down

...and even if they are followed it doesn't mean the best medication will be recognised.

[Airbagwill]

On 10/8/2020 at 8:05 AM, sawadee1947 said:

And your point is ???? 

The fastest vaccine ever developed was for mumps. It took four years.

 

coronaviruses are not new - MERS and SARS for a start......so docs have some information already but...

"A chief concern is that coronaviruses do not tend to trigger long-lasting immunity. About a quarter of common colds are caused by human coronaviruses, but the immune response fades so rapidly that people can become reinfected the next year." - Guardian

Edited October 9, 2020 by Airbagwill

[sawadee1947]

17 hours ago, Airbagwill said:

The fastest vaccine ever developed was for mumps. It took four years.

 

coronaviruses are not new - MERS and SARS for a start......so docs have some information already but...

"A chief concern is that coronaviruses do not tend to trigger long-lasting immunity. About a quarter of common colds are caused by human coronaviruses, but the immune response fades so rapidly that people can become reinfected the next year." - Guardian

Mumps vaccine came to the market in the 70s. Since the science is galloping forward. 

And concerning covid you'll have to wait a bit. 

The first probably will come from Germany in December. We will see how long it will give a response. 

However we don't know much about the Chinese one. They got it already since many months. Hopefully they will show us the results and side effects. 

 

[4MyEgo]

Too much focus has been placed on the all mighty vaccine, the "holy grail" due to misinformation, fear and panic, a well thought up plandemic as more and more evidence comes to light in my opinion.

 

The "standard procedures" that Fauci and his mates collaborated to remove drugs already in the market place which are commonly used for respiratory illnesses have been taken off the market for use on Covid-19, e.g. Hydroxychloroquine and others, while professors, doctors, epidemiologists, biologists and the like have been screaming that they work if given early in the treatment, but they don't want to listen because they know they have them under there schemed "standard procedures" which states that to treat someone for a new virus they must use clinically proven trials to provide them with drugs, now we all know nothing has been tried and proven for Covid-19, and it takes forever to get something to that level, so they have a head start on getting a vaccine to market, they have the FDA and some Universities in their pockets through major sponsorships running into the millions, so here we are with Dr's being forced for the first time in history, having their hands tied, i.e. not being allowed to prescribe drugs to their clients, because Fauci says they haven't had clinical trials to prove they work, apart from the ones that gave them 10 times the dosage and killed the patients, nice way to get that drug out of the way, provide the patient with 10 times the dose, kill them and say it doesn't work.

 

I could go on, but I think there are some of us that see and hear things the way they really are, and I hope I am still alive when it all comes out in the open, the biggest inhumane scam in history. 

Edited October 10, 2020 by 4MyEgo

[Airbagwill]

55 minutes ago, sawadee1947 said:

Mumps vaccine came to the market in the 70s. Since the science is galloping forward. 

And concerning covid you'll have to wait a bit. 

The first probably will come from Germany in December. We will see how long it will give a response. 

However we don't know much about the Chinese one. They got it already since many months. Hopefully they will show us the results and side effects. 

 

Mumps vaccine first appeared in the 1960s. It was and still is the fastest developed vaccine.

 

We are not suddenly going to discover the best vaccine - and of course this is not a cure (there are virtually no cures for a virus).

There are physical restraints on testing any medication and it is very difficult to speed them up beyond a certain point - e.g. double blind trials...... numbers tested  and looking for side effects or just assessing efficacy.

 

Even if they started using a substance on people there is no guarantee it is going to work or be the most effective....so it could be years before any vaccine is around where we can say with any certainty how well it works.

The best we can expect are similar to the flu vaccines which have been developed over decades and are in themselves a system using a range of vaccines.

Edited October 10, 2020 by Airbagwill

[pookondee]

There will be tears spilled when the masses wishing for a vaccine finally get one,

only to find that most countries WILL STILL NOT drop the quarantines and other stupid requirements..

 

And this is why:

 

Most countries are now tolerating

 ZERO risk of anyone entering with Covid.

Hence all the silly hurdles.

 

It has been reported that a vaccine at best will only have a 60-70% chance of being completely effective.

 

So, people entering a country, even having taken a vaccine, will still have a 30-40% chance that they still could be a carrier.

 

think about this again:

They have initiated these quarantines and restrictions wanting ZERO % risk of anyone infected entering...

 

So, who in their right minds thinks they will accept vaccine takers (en-mass) without restriction.. when its found that any 1 traveller will still have a 30-40% chance of being infected anyway??

 

Its time to bite the bullet, grow some baใใs and live with this, and manage it..

 

otherwise we may as well just ban any international travel forever and be done with it.

 

 

 

 

 

 

Edited October 10, 2020 by pookondee

[Airbagwill]

One has also to question Thailand's ability to handle vaccines appropriately.

the recent spike in vaccine deaths was in part attributed to poor vaccine storage or quality.

One could see a black market quickly developing in Thailand if a vaccine ever materialises.

[473geo]

Sure "it is time to grow some balls live with this and manage it" and that is what the speed to produce a vaccine is about.

This illness may well become an annual flu season regular, in order to protect the elderly, other younger people at risk, eliminate the possible crescendo of winter 'sick leave' in the workforce, and the possibility of annual strain on the medical services, the vaccine is a worthy path to follow and speed of production is key to a return to some normality

[sawadee1947]

59 minutes ago, Airbagwill said:

Mumps vaccine first appeared in the 1960s. It was and still is the fastest developed vaccine.

 

We are not suddenly going to discover the best vaccine - and of course this is not a cure (there are virtually no cures for a virus).

There are physical restraints on testing any medication and it is very difficult to speed them up beyond a certain point - e.g. double blind trials...... numbers tested  and looking for side effects or just assessing efficacy.

 

Even if they started using a substance on people there is no guarantee it is going to work or be the most effective....so it could be years before any vaccine is around where we can say with any certainty how well it works.

The best we can expect are similar to the flu vaccines which have been developed over decades and are in themselves a system using a range of vaccines.

I don't agree with you.

It's up to you to get a vaccine next. 

Sure you can wait for several years more until a vaccine will suit you. 

I am happy to get my first one in December. 

[teacherclaire]

I'm afraid that the question should be asked to the Chinese.

 

 MAGAC. Make A Great Wall Around China.  

[teacherclaire]

8 minutes ago, sawadee1947 said:

I don't agree with you.

It's up to you to get a vaccine next. 

Sure you can wait for several years more until a vaccine will suit you. 

I am happy to get my first one in December. 

My apologies, but now it's way too early to ask for something that could also be lethal for some people. 

[sawadee1947]

1 hour ago, teacherclaire said:

My apologies, but now it's way too early to ask for something that could also be lethal for some people. 

Silly 

[stretch5163]

On 10/8/2020 at 11:35 AM, sawadee1947 said:

And your point is ???? 

His point is probably that even though a vaccine may be developed the strains will be different and have mutated so a vaccine is kind of useless.

 

Look at the flu vaccine in the UK the exact same strains multiply and progress renedering vaccine worthless as it only protects against 1 strain,

 

Quite simple really

[stretch5163]

On 10/10/2020 at 3:35 PM, sawadee1947 said:

I don't agree with you.

It's up to you to get a vaccine next. 

Sure you can wait for several years more until a vaccine will suit you. 

I am happy to get my first one in December. 

If your so eager and happy to get a vaccine then why dont you contact someone in china im sure there is an avenue there to get it or even russia why wait till possibly decemebr when maybe the Germans will have a vaccine and maybe they wont.

 

Still not guaranteeed access as people have already said. 

 

Time for countries to put on big boy pants and get on with life or live in fear of this virus for years to come.

[sawadee1947]

5 minutes ago, stretch5163 said:

His point is probably that even though a vaccine may be developed the strains will be different and have mutated so a vaccine is kind of useless.

 

Look at the flu vaccine in the UK the exact same strains multiply and progress renedering vaccine worthless as it only protects against 1 strain,

 

Quite simple really

You think he can't speak for himself? 

[473geo]

10 minutes ago, stretch5163 said:

His point is probably that even though a vaccine may be developed the strains will be different and have mutated so a vaccine is kind of useless.

 

Look at the flu vaccine in the UK the exact same strains multiply and progress renedering vaccine worthless as it only protects against 1 strain,

 

Quite simple really

I think you'll find the UK vaccine protects against 4 strains, also the added incentive that if your immune system is not weakened by seasonal flu it will offer a better chance of beating covid should the need arise

Edited October 11, 2020 by 473geo

[sawadee1947]

22 minutes ago, stretch5163 said:

may be

Exactly. Just out of the blue. No proof but bla-bla 

[Airbagwill]

46 minutes ago, stretch5163 said:

His point is probably that even though a vaccine may be developed the strains will be different and have mutated so a vaccine is kind of useless.

 

Look at the flu vaccine in the UK the exact same strains multiply and progress renedering vaccine worthless as it only protects against 1 strain,

 

Quite simple really

Not quite - We have vaccines for several strains of flu and they actually work quite well. Every season they check which virus strain is going round and use the appropriate vaccine. It is very likely that the same will apply to Corona

Edited October 11, 2020 by Airbagwill

[dabhand]

Looks like the J&J vaccine trial has had to hit the pause button.

 

https://www.theguardian.com/world/2020/oct/12/johnson-johnson-pauses-covid-vaccine-trial-over-participants-unexplained-illness

[Sheryl]

1 minute ago, dabhand said:

Looks like the J&J vaccine trial has had to hit the pause button.

 

https://www.theguardian.com/world/2020/oct/12/johnson-johnson-pauses-covid-vaccine-trial-over-participants-unexplained-illness

Happens in all trials, absolutely routine