Covid Vaccine Setbacks Temper Optimism After Upbeat News

[Becky1951]

Covid Vaccine Setbacks Temper Optimism After Upbeat News

Vaccine makers, including two of the biggest in the world, suffered setbacks in the push to get more Covid-19 shots across the line, tempering a run of positive news.

Sanofi and GlaxoSmithKline Plc delayed advanced trials of their experimental Covid-19 shot after it failed to produce a strong enough response in older people, pushing its potential availability to the end of next year. In another blow, trials of a vaccine being developed by CSL Ltd. and the University of Queensland in Australia ran into difficulties.

Sanofi and its U.K. partner will begin a new second-phase study with a more concentrated antigen in February after they said the current dosage failed to generate a good immune response in people 50 years and older. Younger adults showed a response similar to patients who have recovered from the disease.

The problem arose after two different reagents used to measure vaccine formulations provided inaccurate information about the concentration of antigens, Sanofi said in an emailed statement. The companies notified U.S. officials about the matter.

The delay underscores the difficulties and uncertainties companies face in developing shots in record time against a disease that’s already claimed more than 1.5 million lives. It’s also a blow for governments that were counting on supplies from the two vaccine giants amid expectations the world will need multiple inoculations to stop the spread of the pathogen.

Bloomberg

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Prognosis

Covid Vaccine Setbacks Temper Optimism After Upbeat News

By

Tim Loh

and

Suzi Ring

December 11, 2020, 1:16 AM ESTUpdated on December 11, 2020, 8:05 AM EST

Sanofi and GSK delay Covid vaccine as results fall short

Australia cancels order of University of Queensland shot

Global Virus Network's Gallo on Covid-19 Vaccines

Unmute

Global Virus Network's Gallo on Covid-19 Vaccines

Vaccine makers, including two of the biggest in the world, suffered setbacks in the push to get more Covid-19 shots across the line, tempering a run of positive news.

Sanofi and GlaxoSmithKline Plc delayed advanced trials of their experimental Covid-19 shot after it failed to produce a strong enough response in older people, pushing its potential availability to the end of next year. In another blow, trials of a vaccine being developed by CSL Ltd. and the University of Queensland in Australia ran into difficulties.

Sanofi and its U.K. partner will begin a new second-phase study with a more concentrated antigen in February after they said the current dosage failed to generate a good immune response in people 50 years and older. Younger adults showed a response similar to patients who have recovered from the disease.

The problem arose after two different reagents used to measure vaccine formulations provided inaccurate information about the concentration of antigens, Sanofi said in an emailed statement. The companies notified U.S. officials about the matter.

The delay underscores the difficulties and uncertainties companies face in developing shots in record time against a disease that’s already claimed more than 1.5 million lives. It’s also a blow for governments that were counting on supplies from the two vaccine giants amid expectations the world will need multiple inoculations to stop the spread of the pathogen.

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Australia meanwhile canceled an order for 51 million doses of a Covid shot being developed by CSL and the Australian university. A component of the vaccine comes from the human immunodeficiency virus, and while that posed no risk of infection, some trial participants had false positive tests for HIV.

The announcements temper some of the optimism following positive trial results from Pfizer Inc. and Moderna Inc. Another inoculation from AstraZeneca Plc and the University of Oxford looks promising, too, despite questions about its effectiveness in older adults. The U.K. and Canada have already approved a shot from Pfizer and partner BioNTech SE that employs messenger RNA technology, and the U.S. and Europe may do so soon. China and Russia have already begun administering their own vaccinations.

https://www.bloomberg.com/news/arti...-covid-vaccine-after-elderly-get-little-boost

 

[oldman]

Herein lies a potential problem. Once the Pfizer vaccine and Moderna vaccine hits the streets, I have to wonder if we may see any copycats pop up? The last I heard about the Russian vaccine was that it had a 92% efficacy rate, but several people in the trials were contacting the Virus.

Do we believe that China may try to copy the vaccine? It’s no secret that the Chinese are not innovators, just duplicators.

 

[Aunt Marg]

Herein lies a potential problem. Once the Pfizer vaccine and Moderna vaccine hits the streets, I have to wonder if we may see any copycats pop up? The last I heard about the Russian vaccine was that it had a 92% efficacy rate, but several people in the trials were contacting the Virus.

Do we believe that China may try to copy the vaccine? It’s no secret that the Chinese are not innovators, just duplicators.

I just listened to a radio broadcast where a scientist defined "efficacy rate" for the audience.

His words were... "if a drug has an efficacy rate of 95%, it does not mean that it will be 95% effective".

The scientist went on to further explain that "effective rates are far lower than efficacy rates".

I would venture to say that a whole lot of people are completely oblivious of the above facts.

 

[StarSong]

A good explanation of the difference between efficiency & efficacy from
https://www.wtsp.com/article/news/h...o-far/67-9461b759-b526-429c-b7af-cb5e4e8118f8

With Pfizer and Moderna at 95 percent efficacy, let's give you some sharper insight into what that means.

We'll do that with the expertise of our country's top infectious disease expert, Dr. Anthony Fauci. He held a conversation about this topic with The Hastings Center.

First off, he says the primary endpoint of the Pfizer and Moderna trials was a clinically apparent disease, which could be mild to moderate. The secondary endpoint was infection or severe disease.

Then he explained the difference between efficacy and effectiveness.

Efficacy is the result of the trial under appropriately controlled conditions.

Effectiveness is how the vaccine impacts the population that you ultimately want to impact.

So right now, Dr. Fauci says we have highly efficacious vaccines.

"How effective they will be, on society will be determined by a number of factors including how many people decide they want to get vaccinated. So if you have a 95 percent efficacious vaccine and only 50 percent of the people want to get vaccinated, that's not going to be a very effective tool," Fauci said.

So Dr. Fauci says what we don't know yet is whether these vaccines are effective in preventing infection, which is part of that secondary endpoint.

He says we know two things: it's efficacious in preventing infection that is clinically recognizable, and it also is effective in preventing severe disease. What we don't know yet is whether it's effective in preventing infection.

"In other words, am I a person who was infected but I didn't get symptoms I count as a plus for the vaccine, but I'm still infected. Now the question that we don't know, which is going to be very interesting, if I'm infected, but was vaccinated, is the level of virus going to be so low in me, because even though I got infected, the immune response dampened the level of virus, so that I'm not going to be infecting other people. That we don't know."