Vaccine Competition is Coming Up And That's a Good Thing

Mish

A second major U.S. coronavirus vaccine could possibly be shipped by this weekend.

More Good Vaccine News

There's more good news on the vaccine front. The FDA Finds Moderna Covid-19 Vaccine Highly Effective.

The Food and Drug Administration said Tuesday that the Covid-19 vaccine developed by Moderna Inc. MRNA  was “highly effective,” setting the stage for an emergency authorization later this week that would add a second vaccine to the arsenal against the pandemic.

Barring complications, the FDA is aiming to authorize emergency use of the Moderna vaccine Friday, following the same timetable as last week with the first Covid-19 vaccine from Pfizer Inc. and BioNTech SE.

Moderna’s analysis, posted by the FDA, also included new data suggesting that the first dose of its vaccine can reduce infections that don’t cause symptoms. If this finding holds up in further analysis—including after the second of the two-dose regimen—it could mean that the vaccine not only protects individuals from disease, but also curbs transmission of the virus from person to person.

Moderna has said it expects to have 20 million doses available for the U.S. to ship by the end of 2020, enough to inoculate 10 million people with the two-shot regimen. Moderna, with its own manufacturing plant and working with contract manufacturers, expects to produce between 500 million and 1 billion doses in 2021 for global use.

FDA Analysis

There is no excuse for failure to link to the study, but unfortunately that is typical. 

Here is the FDA Report. 

Moderna Efficiency

Moderna Efficiency

Moderna Efficiency Final Analysis

Moderna Efficiency Final Analysis

Key Points

  • All 11 cases of severe COVID-19 at least 14 days after second dose as assessed by the  adjudication committee were in the placebo group.
  • Of these 11 participants, 5 had risk factors for severe COVID-19 and 6 did not. 
  • In the primary efficacy analysis, there were an additional 19 cases of severe COVID-19 (one of which resulted in death from COVID-19), for a total of 30 severe COVID-19 cases starting 14 days after dose 2, per adjudication committee assessment. 
  • All 30 cases were in the placebo group. Nine of the total 30 severe COVID-19 cases resulted in hospitalization. 

The Most Urgent Vaccination Effort Since Polio Shots has Launched

Previously I noted The Most Urgent Vaccination Effort Since Polio Shots in the 1950s has Launched

Competition Is a Good Thing

The problem with the Pfizer vaccine was the extreme cold storage and handling conditions it required. 

Moderna is much less sensitive. 

In addition, two sources will provide competition, increase supplies,  and help keep costs down.

Mish

Comments (52)
No. 1-20
njbr
njbr

Moderna’s vaccine has had much smoother sailing. The F.D.A. review showed that it worked equally well in white, Black and Hispanic volunteers, men and women, healthy participants and those at risk of severe Covid-19 with conditions like obesity and diabetes. For people 65 and older, the trial provided an estimated efficacy of 86.4 percent, lower than the overall estimate of 94.1 percent. But the apparent difference was not statistically significant. And 86.4 percent is still very high.

So far, two potential differences between the Pfizer-BioNTech and Moderna vaccines have emerged in the F.D.A.’s reviews, but the findings may reflect a shortage of data rather than genuine distinctions....

....Moderna produced more evidence that its vaccine can prevent severe disease. Of 30 volunteers who developed severe cases of Covid, all had received the placebo, not the vaccine....

.....How long that protection will last is still an open question. In a recent study, Moderna found that three months after the second dose, volunteers were still making high levels of antibodies. But researchers don’t yet know what levels are needed to maintain immunity. Time, and more research, will tell whether booster shots will be required.

Another puzzle is whether the vaccine can prevent people from spreading the disease, which would greatly help to stop the pandemic. Those who are infected but have no symptoms are thought to be a major source of transmission.

A vaccine that prevents illness might still allow people to become infected and harbor the virus in their noses long enough to transmit it.

New data from Moderna suggest that its vaccine may reduce transmission. Researchers found that people who had one shot were less likely than those in the placebo group to have symptom-free infections in their noses — and therefore less likely to be contagious....

njbr
njbr

The most likely option for most Americans will be Moderna, which I am happy with, for the reasons above.

Sechel
Sechel

I'm having trouble understanding h ki w the pfizer and moderna vaccine are considered equivalent. Granted they both are 95% effective but the moderna dose is smaller and is less fragile meaning requiring less refrigeration

Eddie_T
Eddie_T

At this point the vaccine shortage IS the issue. We need to get ramped up much faster than what is happening with the Pfizer product.

If Moderna can ship more vaccine, then we should be taking the Moderna vaccine.

Like..this week. People are dying. Numbers are going exponential in a lot of places.

Over the longer term more competition means a better price point...but let’s not worry too much about how much it costs right now.....lets get the vaccine out there so people who want to take it can take it.

People who have concerns about safety can wait....very soon the data will be out there on safety. Millions of people will be vaccinated and we can look at the data on side effects and efficacy with the advantage of large group studies.

My guess is that there will be a small but significant cohort that will find reasons to not take the vaccine not matter how safe it is......no amount of data will satisfy them.

ajc1970
ajc1970

Are they vaccinating for free?

You mention keeping costs down. I'm sitting here thinking that every US taxpayer has paid the cost for this vaccine and then some, and they're pressuring/requiring people to get jabbed -- this should be a "free" distribution.

Felix_Mish
Felix_Mish

Good news, if I read a graph right:

The FDA report, Figure 2, top of page 28, shows C19 incidence counts over time for the two groups, vaccine and placebo. The placebo group has a smooth, rising curve. The vaccine group's curve never really takes off.

C19 incident numbers from the study are really low, so there's always a question of whether they might be noise or whatnot.

That smoothness says the numbers over time are solid - not random noise.

Dodge Demon
Dodge Demon

On ZH -

NICK THE GREEK RESTAURANT OWNER ASKS PUBLIC HEALTH INSPECTORS ISSUING CITATION: “ARE YOU GOING TO PAY MY RENT?”

Money Shot -

"Are you going to pay my rent ? says owner Anton Van Happen of 'Nick The Greek' to public health inspectors issuing him a citation for staying open after being issued a closure order.

"Why aren't you at Costco right now, there's 500 people inside Costco" a customer of 'Nick The Greek' says to public health inspectors.

All animals are equal, but some animals are more equal than others.

Anda
Anda

Assuming those most vulnerable would take the vaccine, very roughly:

"Of these 11 participants, 5 had risk factors for severe COVID-19 and 6 did not. "

So @ 50% of severe are those not vulnerable.

"In the primary efficacy analysis, there were an additional 19 cases of severe COVID-19 (one of which resulted in death from COVID-19), for a total of 30 severe COVID-19 cases starting 14 days after dose 2, per adjudication"

So very @ (and if p.e.a. doesnt include the first 11) @ 10 not vulnerable (19x50%) were severe of 156 (not vulnerable) <65 who caught the virus. Therefore it stopped the 6% of severe cases that occured in those not vulnerable infected, and stopped the 30% number of hospitalised of those - roughly the two of every hundred infected.

The fatality I put as in the vulnerable group who "would have made a choice" to be vaccinated - because fatalities in non vulnerable are much less an occurrence by all other data.

So millions of people are vaccinated... sorry how often the double shots !?... continuously ? .... so that during whatever total time frame, two of every hundred not vulnerable infected.... or 2 % of 1.5 % (case n%) = 0.03% .... that is 300 per million people during that time frame ... do not end up in hospital. Ultimately sparing 20 000 hospital visits per million people assuming they were all infected.

That is being optimistic, ignoring sequela, rare fatalities that would occur in both groups, side effects of vaccine, new strains etc.

That those vaccinated are less contagious is obvious, sort of sad to see it used as promo for having others vaccinated.

Well, it's a perspective, and people of whatever group are going to choose what they choose, most of the 20 000 by choice non vaccinated who end up in hospital will probably think they made the wrong choice, most of the other 980 000 probably not.

Free to correct those figures if there is large error.

Felix_Mish
Felix_Mish

Anybody else notice in the tables @Mish has snapshotted, the placebo 65+ group had Covid 19 half as often as the 18-65 group? .4% against .7%, 20 against 40, 30 against 60, depending on the number.

Gotta remember, the trial happened with the participants behaving differently than they would have a year earlier.

Webej
Webej

Efficacious at what? I have a Hard Drive on my desk that is a particularly efficacious paper weight, but not much for data storage.

There are many measures of efficacy, but one of the most pertinent is not yet known: How many people do you need to vaccinate to prevent a single death?

pierick.sisto
pierick.sisto

It's great to see that soon this pandemic will stop, but the economic backlash that happened still affects millions of americans in a economic way. Nevertheless there are many ways to earn money, for example, investing in cryptocurrencies like Bitcoin, sites like http://www.mintme.com teach the people how to start in this form of monetary system.

PecuniaNonOlet
PecuniaNonOlet

Haven't really seen any info on side effects, you know the kind that every pharma tv commercial disclaimer says like, "may cause dizziness, blindness or internal bleeding....in some cases death was reported......consult your physician if xxx is right for you...."

Additionally, as other have pointed out, will vaccinated people turn into super spreaders now that they are immune they will act more freely (not wear mask) and socialize everywhere resulting in faster deeper spreading than before!

njbr
njbr

LONDON (Reuters) - British scientists are trying to establish whether the rapid spread in southern England of a new variant of the virus that causes COVID-19 is linked to key mutations they have detected in the strain, they said on Tuesday.

Slideshow ( 5 images )
The mutations include changes to the important “spike” protein that the SARS-CoV-2 coronavirus uses to infect human cells, a group of scientists tracking the genetics of the virus said, but it is not yet clear whether these are making it more infectious.

"Efforts are under way to confirm whether or not any of these mutations are contributing to increased transmission," the scientists, from the COVID-19 Genomics UK (COG-UK) Consortium, said in a statement (bit.ly/3mhpTJX).

The new variant, which UK scientists have named “VUI – 202012/01” includes a mutation in the viral genome region encoding the spike protein, which - in theory - could result in COVID-19 spreading more easily between people.

The British government on Monday cited a rise in new infections, which it said may be partly linked to the new variant, as it moved its capital city and many other areas into the highest tier of COVID-19 restrictions.

As of Dec. 13, 1,108 COVID-19 cases with the new variant had been identified, predominantly in the south and east of England, Public Health England said in a statement.

But there is currently no evidence that the variant is more likely to cause severe COVID-19 infections, the scientists said, or that it would render vaccines less effective.

“Both questions require further studies performed at pace,” the COG-UK scientists said.

njbr
njbr

A good breakdown of some longer-term problems from getting covid--better, but not fine.

njbr
njbr

From SCMP

Should Hongkongers get a financial incentive for taking the new Covid-19 vaccines? Some local lawmakers think so.

Hong Kong lawmakers have suggested providing a cash incentive of up to HK$5,000 (US$645) to encourage residents to get vaccinated against the coronavirus when the first million shots become available early next year.

Chief Executive Carrie Lam Cheng Yuet-ngor last Friday announced that a deal had been reached to secure 15 million shots of Covid-19 vaccines manufactured on the mainland and in Europe, but faced tough questions as to whether residents would be open to jabs manufactured and distributed by Chinese companies.

On Wednesday, Secretary for Food and Health Sophia Chan Siu-chee continued to face questions from lawmakers on the Legislative Council health services panel about how the government would encourage residents to get vaccinated.
Secretary for Food and Health Sophia Chan addressed concerns from local lawmakers over the city’s pending vaccine programme on Wednesday.

“You have already been criticised by residents when you said infected people would be given a subsidy, so will there be a cash reward for getting the shots?” Leung Che-cheung of the pro-establishment Democratic Alliance for the Betterment and Progress of Hong Kong (DAB) asked Chan.

“If there is nothing to motivate residents to be vaccinated, it will be the end of Hong Kong. So if HK$3,000 is not enough, then give them HK$5,000,” he said.
Insurance industry lawmaker Chan Kin-por also said he had heard from constituents asking if they would be given cash for taking the Covid-19 shot.


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