It will be hard to tell the difference because most anti-vaxxers are already batshiat insane.
Latest Vaccine News
- Thread starter gwb-trading
- Start date
It will be hard to tell the difference because most anti-vaxxers are already batshiat insane.
I’m unsure this cohort will get the vaccine in any meaningful percentages. Even people who are ok with vaccinating adults will balk at children for quite some time.
Ocugen jumps 27% after its COVID-19 vaccine shows potential effectiveness against virus variants
https://markets.businessinsider.com...ffectiveness-virus-variants-2021-5-1030379666
Covaxin, co-developed with Indian firm Bharat Biotech, demonstrated potential effectiveness against the variant of SARS-CoV-2 first discovered in Brazil.
A previous study conducted also suggested that Covaxin was effective against variants first seen in the UK and India, suggesting the vaccine's effectivity against multiple strains of COVID-19.
The company has submitted a comprehensive drug master file with the US Food and Drug Administration and is preparing the vaccine's emergency use authorization application, according to Dr. Shankar Musunuri, CEO and co-founder of Ocugen.
Currently, there are only three authorized and recommended vaccines in the US to prevent COVID-19, from Pfizer-BioNTech, Moderna, and Johnson & Johnson.
In the recently shared second interim results of the phase 3 clinical trial, Covaxin demonstrated 78% overall efficacy and 100% in severe COVID-19 disease - including hospitalization.
https://markets.businessinsider.com...ffectiveness-virus-variants-2021-5-1030379666
- Shares of Ocugen jumped 27% on Monday after the company announced positive news related to its COVID-19 vaccine.
- The company said Covaxin has shown signs of potential effectiveness against three variants of the coronavirus.
- Covaxin is India's COVID-19 vaccine, which Ocugen is codeveloping for the US market.
Covaxin, co-developed with Indian firm Bharat Biotech, demonstrated potential effectiveness against the variant of SARS-CoV-2 first discovered in Brazil.
A previous study conducted also suggested that Covaxin was effective against variants first seen in the UK and India, suggesting the vaccine's effectivity against multiple strains of COVID-19.
The company has submitted a comprehensive drug master file with the US Food and Drug Administration and is preparing the vaccine's emergency use authorization application, according to Dr. Shankar Musunuri, CEO and co-founder of Ocugen.
Currently, there are only three authorized and recommended vaccines in the US to prevent COVID-19, from Pfizer-BioNTech, Moderna, and Johnson & Johnson.
In the recently shared second interim results of the phase 3 clinical trial, Covaxin demonstrated 78% overall efficacy and 100% in severe COVID-19 disease - including hospitalization.
Soon are the anti-vaxxers whining that the Pfizer vaccine is not "approved" since it only has emergency use authorization will have to shut the f@ck up.
Pfizer plans to file for full FDA approval of Covid vaccine at the end of this month
https://www.cnbc.com/2021/05/04/pfizer-pfe-earnings-q1-2021.html
Pfizer said Tuesday it plans to file for full U.S. approval of its Covid-19 vaccine with German drugmaker BioNTech at the end of this month. If the FDA signs off, the company will be able to market the shot directly to consumers.
In its earnings report, Pfizer said first-quarter sales of its Covid-19 vaccine was $3.5 billion, roughly 24% of its revenue for the quarter. Its profit and revenue beat Wall Street’s expectations.
Here’s how Pfizer did compared with what Wall Street expected, according to average estimates compiled by Refinitiv:
Shares of Pfizer rose 1.3% in premarket trading.
“Based on what we’ve seen, we believe that a durable demand for our Covid-19 vaccine, similar to that of the flu vaccines, is a likely outcome,” Pfizer CEO Albert Bourla told investors on an earnings call.
Revenue from Pfizer’s oncology, internal medicine, hospital and rare disease units rose by double digits during the quarter, according to the earnings report. The company’s inflammation and immunology unit generated about $1 billion in sales, a 9% increase from a year earlier.
Pfizer reported double-digit growth in sales for many of its cancer drugs, including Inlyta, Bosulif and Lorbrena.
The company received U.S. authorization of its Covid vaccine in late December. Since then, Pfizer has distributed millions of doses to the U.S., with the goal of delivering 300 million doses by the end of July.
Usually, it takes the Food and Drug Administration nearly a year or longer to determine whether a drug is safe and effective for use in the general public. Due to the once-in-a-century pandemic, which has killed nearly 600,000 people in the United States, the FDA permitted the use of the shots under an Emergency Use Authorization.
The authorization grants conditional approval based on two months of data. It’s not the same as a Biologic License Application, which requires six months of data and secures full approval.
The company also said it expects to apply for an EUA for a booster shot that could protect against Covid variants during the second half of July, according to a slide presentation that accompanied the company’s earnings release. It expects to apply for authorization for its vaccine for use in toddlers and younger children in September and infants in November.
It also expects vaccine safety data for pregnant women in late July.
On April 1, Pfizer and BioNTech announced that new data from their clinical trial showed their two-dose vaccine was safe and more than 91% effective six months after the second dose. At the time, Pfizer CEO Albert Bourla said the new data positions the companies “to submit a Biologics License Application to the U.S. FDA.”
If the vaccine is fully approved, it sets the stage for Pfizer and BioNTech to begin advertising the shots directly to consumers and change its pricing. It also allows the shot to stay on the market once the pandemic is over and the U.S. is no longer considered in an “emergency.”
Pfizer plans to file for full FDA approval of Covid vaccine at the end of this month
https://www.cnbc.com/2021/05/04/pfizer-pfe-earnings-q1-2021.html
Pfizer said Tuesday it plans to file for full U.S. approval of its Covid-19 vaccine with German drugmaker BioNTech at the end of this month. If the FDA signs off, the company will be able to market the shot directly to consumers.
In its earnings report, Pfizer said first-quarter sales of its Covid-19 vaccine was $3.5 billion, roughly 24% of its revenue for the quarter. Its profit and revenue beat Wall Street’s expectations.
Here’s how Pfizer did compared with what Wall Street expected, according to average estimates compiled by Refinitiv:
- Adjusted EPS: 93 cents per share vs. 77 cents expected
- Revenue: $14.58 billion vs. $13.51 billion expected
Shares of Pfizer rose 1.3% in premarket trading.
“Based on what we’ve seen, we believe that a durable demand for our Covid-19 vaccine, similar to that of the flu vaccines, is a likely outcome,” Pfizer CEO Albert Bourla told investors on an earnings call.
Revenue from Pfizer’s oncology, internal medicine, hospital and rare disease units rose by double digits during the quarter, according to the earnings report. The company’s inflammation and immunology unit generated about $1 billion in sales, a 9% increase from a year earlier.
Pfizer reported double-digit growth in sales for many of its cancer drugs, including Inlyta, Bosulif and Lorbrena.
The company received U.S. authorization of its Covid vaccine in late December. Since then, Pfizer has distributed millions of doses to the U.S., with the goal of delivering 300 million doses by the end of July.
Usually, it takes the Food and Drug Administration nearly a year or longer to determine whether a drug is safe and effective for use in the general public. Due to the once-in-a-century pandemic, which has killed nearly 600,000 people in the United States, the FDA permitted the use of the shots under an Emergency Use Authorization.
The authorization grants conditional approval based on two months of data. It’s not the same as a Biologic License Application, which requires six months of data and secures full approval.
The company also said it expects to apply for an EUA for a booster shot that could protect against Covid variants during the second half of July, according to a slide presentation that accompanied the company’s earnings release. It expects to apply for authorization for its vaccine for use in toddlers and younger children in September and infants in November.
It also expects vaccine safety data for pregnant women in late July.
On April 1, Pfizer and BioNTech announced that new data from their clinical trial showed their two-dose vaccine was safe and more than 91% effective six months after the second dose. At the time, Pfizer CEO Albert Bourla said the new data positions the companies “to submit a Biologics License Application to the U.S. FDA.”
If the vaccine is fully approved, it sets the stage for Pfizer and BioNTech to begin advertising the shots directly to consumers and change its pricing. It also allows the shot to stay on the market once the pandemic is over and the U.S. is no longer considered in an “emergency.”
Europe starts considering a Chinese COVID-19 vaccine for approval
https://fortune.com/2021/05/04/coronavac-sinovac-covid-vaccine-eu-ema-rolling-review/
Europe's top health regulator has begun evaluating China's CoronaVac COVID-19 vaccine for potential use in the European Union.
The European Medicines Agency (EMA) said Tuesday that its rolling review of data for the vaccine would "continue until enough evidence is available" for the vaccine's developer, Sinovac BioTech, to file a formal application for authorization.
This process is supposed to reduce the amount of time needed to evaluate the eventual application. Other vaccines in the EMA's pipeline include Russia's Sputnik V, Germany's CureVac, and the U.S.'s Novavax. The agency has already green-lit the BioNTech/Pfizer, Moderna, AstraZeneca, and Johnson & Johnson vaccines.
CoronaVac, or "COVID-19 Vaccine (Vero Cell) Inactivated" as it is more formally known, is unique among these vaccines in that it uses the SARS-CoV-2 virus itself—albeit in killed-off form—to trigger the immune response that leads to inoculation. India's Covaxin takes the same approach, as do Valneva's under-development vaccine and QazVac, Kazakhstan's homegrown jab.
The level of CoronaVac's efficacy is not certain. Turkish researchers have put it as high as 83.5%, which would make the jab more effective than AstraZeneca or J&J's vaccines. But it barely cleared the 50% threshold in Brazil—though that could be because trials there were largely dealing with the extremely dangerous P.1 coronavirus variant. CoronaVac's finalized trial data is yet to be published in a peer-reviewed journal.
Gao Fu, the head of the Chinese Centers for Disease Control and Prevention, caused a stir last month when he admitted that China's vaccines—including CoronaVac and Sinopharm—"don't have very high rates of protection." However, he subsequently claimed reports of the admission were a "complete misunderstanding."
Approval effects
The European Union is mostly acting as a collective in its approval and purchasing of COVID-19 vaccines. However, the slow start to Europe's vaccination drive—which has recently picked up significant pace—led some Eastern European countries to consider non-Western alternatives.
Hungary in particular bypassed the European Commission's bulk purchasing mechanisms to secure its own supplies of Sputnik V and Sinopharm.
EMA approval does not necessarily mean the European Commission will place an order. For example, Internal Market Commissioner Thierry Breton—the head of the Commission's vaccine task force—has repeatedly said the EU has no need for Sputnik V, even though the EMA is evaluating it.
CoronaVac has already been approved for use in a couple dozen countries, including Turkey, Brazil, Chile, Mexico, Thailand, Zimbabwe, and of course China itself.
The World Health Organization is evaluating both CoronaVac and Sinopharm for potential approval. If it gives the go-ahead, the Chinese vaccines could then be included in the WHO-backed COVAX program, which is distributing low-cost doses to low- and middle-income countries.
Vaccine deals aside, though, an EMA recommendation for the approval of CoronaVac could have a big impact on Chinese tourism in the EU. The European Commission officially proposed this week that the EU should open its borders to travelers who have been fully vaccinated with EMA-approved jabs.
https://fortune.com/2021/05/04/coronavac-sinovac-covid-vaccine-eu-ema-rolling-review/
Europe's top health regulator has begun evaluating China's CoronaVac COVID-19 vaccine for potential use in the European Union.
The European Medicines Agency (EMA) said Tuesday that its rolling review of data for the vaccine would "continue until enough evidence is available" for the vaccine's developer, Sinovac BioTech, to file a formal application for authorization.
This process is supposed to reduce the amount of time needed to evaluate the eventual application. Other vaccines in the EMA's pipeline include Russia's Sputnik V, Germany's CureVac, and the U.S.'s Novavax. The agency has already green-lit the BioNTech/Pfizer, Moderna, AstraZeneca, and Johnson & Johnson vaccines.
CoronaVac, or "COVID-19 Vaccine (Vero Cell) Inactivated" as it is more formally known, is unique among these vaccines in that it uses the SARS-CoV-2 virus itself—albeit in killed-off form—to trigger the immune response that leads to inoculation. India's Covaxin takes the same approach, as do Valneva's under-development vaccine and QazVac, Kazakhstan's homegrown jab.
The level of CoronaVac's efficacy is not certain. Turkish researchers have put it as high as 83.5%, which would make the jab more effective than AstraZeneca or J&J's vaccines. But it barely cleared the 50% threshold in Brazil—though that could be because trials there were largely dealing with the extremely dangerous P.1 coronavirus variant. CoronaVac's finalized trial data is yet to be published in a peer-reviewed journal.
Gao Fu, the head of the Chinese Centers for Disease Control and Prevention, caused a stir last month when he admitted that China's vaccines—including CoronaVac and Sinopharm—"don't have very high rates of protection." However, he subsequently claimed reports of the admission were a "complete misunderstanding."
Approval effects
The European Union is mostly acting as a collective in its approval and purchasing of COVID-19 vaccines. However, the slow start to Europe's vaccination drive—which has recently picked up significant pace—led some Eastern European countries to consider non-Western alternatives.
Hungary in particular bypassed the European Commission's bulk purchasing mechanisms to secure its own supplies of Sputnik V and Sinopharm.
EMA approval does not necessarily mean the European Commission will place an order. For example, Internal Market Commissioner Thierry Breton—the head of the Commission's vaccine task force—has repeatedly said the EU has no need for Sputnik V, even though the EMA is evaluating it.
CoronaVac has already been approved for use in a couple dozen countries, including Turkey, Brazil, Chile, Mexico, Thailand, Zimbabwe, and of course China itself.
The World Health Organization is evaluating both CoronaVac and Sinopharm for potential approval. If it gives the go-ahead, the Chinese vaccines could then be included in the WHO-backed COVAX program, which is distributing low-cost doses to low- and middle-income countries.
Vaccine deals aside, though, an EMA recommendation for the approval of CoronaVac could have a big impact on Chinese tourism in the EU. The European Commission officially proposed this week that the EU should open its borders to travelers who have been fully vaccinated with EMA-approved jabs.
You are dancing with the devil with these pharma companies. They all have their turn in the barrel and in the penalty box for bad behavior. They do love to fudge the data if they get a chance. All of em. Of course the Ruskies and Chinese don't have any data so you do not need to worry about them doing it.
I was reading an article the other day that said that one of the problems with the Sputnik virus is that countries have been finding live virus in the vaccines- not necessarily the corona virus but the adenovirus/common cold used to transport the nucleus code material from the corona virus. When confronted the Ruskies allege that they never said that there was no live virus, only that it was below a certain level. That certain level needs to be ZERO in the U.S. and most western countries. Sheesh.
Anyway, I guess this is actually a therapeutic, not a vaccine, but same behavior. These guys are always playing the edges.
EXCLUSIVE Lilly hit by staff accusations, FDA scrutiny at COVID drug factories
https://www.reuters.com/business/he...fda-scrutiny-covid-drug-factories-2021-05-05/
I was reading an article the other day that said that one of the problems with the Sputnik virus is that countries have been finding live virus in the vaccines- not necessarily the corona virus but the adenovirus/common cold used to transport the nucleus code material from the corona virus. When confronted the Ruskies allege that they never said that there was no live virus, only that it was below a certain level. That certain level needs to be ZERO in the U.S. and most western countries. Sheesh.
Anyway, I guess this is actually a therapeutic, not a vaccine, but same behavior. These guys are always playing the edges.
EXCLUSIVE Lilly hit by staff accusations, FDA scrutiny at COVID drug factories
https://www.reuters.com/business/he...fda-scrutiny-covid-drug-factories-2021-05-05/
Speaking of European problems. We in the west are heading into a seasonal slowdown of Covid. Europe’s slow rollout will not help their vaccination efforts now that Covid will be transmitted at a naturally slower rate in the spring and summer. People are going to feel less compelled to get vaccinated in this season.
Yeh, I don't know where we are with these "seasonal slowdown" theories these days. That used to be a Trump theory - ie. that it would slow down as the weather warmed up. And, thus, the lefties here and in the media mocked the bejesus out of him for it. In addition we ramped up into a brisk second wave in the first to second week of July and in to September- solidly within the warm weather period.
To complicate that theory even more, covid cases started declining extremely precipitously about the first or second week in January- even before Joe and definitely before significant amount of vaccine was out and about. In other words, right in middle of traditional flu season. So if we had a second surge in the middle of the summer and serious plummet in the middle of winter, then I don't know which time of the year should be considered the "seasonal slowdown. If one takes the view that those cycles were related to mask/no mask behavior well that may or may not be true but then that would be a masking factor, not a seasonal factor.
No punchline. Just saying I participated in the seasonal theory as something which made sense to watch for, given the flu's behavior- but with some history under our belt, I don't see any more juice in it.
I will take the good news of a slowdown though. I just don't think it is necessarily due to seasonal factors.
Last edited:
You are giving Trump a very generous historical revision of his famous “it will disappear” in the warmer months statement. But I suppose Trump had the proper information but couldn’t help being a pathological liar so he had to embellish the “bejeebus” out of it.
Even with that you still make a fair point about seasonal slowdown. However, i still believe there is an aspect to Covid being cyclical and I guess we will see as we move back to “normal.”
My hunch is that there will be a wave of spread among the unvaccinated regardless of season coming after July and then we will get into some kind of natural balance with this possibly genetically engineered neurological super contagious respiratory nightmare.
U.S. Herd Immunity Could Be Coming by End of June
Limited vaccine supply in other countries could make global immunity tougher to achieve, though...
https://www.morningstar.com/articles/1037072/us-herd-immunity-could-be-coming-by-end-of-june
wrbtrader
Limited vaccine supply in other countries could make global immunity tougher to achieve, though...
https://www.morningstar.com/articles/1037072/us-herd-immunity-could-be-coming-by-end-of-june
wrbtrader