Pfizer Drops India Vaccine Application After Regulator Seeks Local Trial

Pfizer ^ | 02/05/22 | Krishna N. Das

[Enlightened1]

NEW DELHI, Feb 5 (Reuters) - Pfizer Inc (PFE.N) said on Friday it had withdrawn an application for emergency-use authorisation of its COVID-19 vaccine in India, after failing to meet the drug regulator's demand for a local safety and immunogenicity study.

The decision means the vaccine will not be available for sale in the world's two most populous countries, India and China, in the near future. Both countries are running their immunisation campaigns using other products.

Unlike other companies conducting small studies in India for foreign-developed vaccines, Pfizer had sought an exception citing approvals it had received elsewhere based on trials done in countries such as the United States and Germany. read more

Indian health officials say they generally ask for so-called bridging trials to determine if a vaccine is safe and generates an immune response in its citizens. There are, however, provisions under India's rules to waive such trials in certain conditions.

The U.S. company, which was the first drugmaker to seek emergency approval in India for its vaccine developed with Germany's BioNTech (22UAy.DE), made the withdrawal decision after a meeting with India's Central Drugs Standard Control Organisation (CDSCO) on Wednesday.

The drug regulator said on its website its experts did not recommend the vaccine because of side effects reported abroad were still being investigated. It also said Pfizer had not proposed any plan to generate safety and immunogenicity data in India.

[irishjuggler]

Of course. The last thing Pfizer wants is actual data on the efficacy of its vax, or, more precisely, the lack of efficacy thereof.

[E. Pluribus Unum]

Can’t have an actual clinical study now, can we?

[WKUHilltopper]

Too bad the US has been outclassed by India. It will only take Pfizer 75 years to get the data here...

P.S. It’s not a vaccine!

[rolling_stone]

pfizer needs to be on trial...

[Brian Griffin]

The shareholders of Pfizer should be upset.

Vaccines can become outdated. A day lost means sales are lost.

[Owen]

I doubt the numbers worked for Pfizer. India wasn’t going to pay US prices for the product. A local trial would raise costs.

There was not going to be profit to be earned. I would suspect the Covaxin and Covishield people were going to undercut any Pfizer advertising, too.

[Brian Griffin]

They had clinical trials.

They were too small to get highly accurate side effect rates on products that rarely (one in many thousands) have prolonged severe side effects.

This has allowed doubts about Covid vaccine safety to fester.

[E. Pluribus Unum]

Then they weren’t actually clinical trials.

[jerod]

India is an AstraZeneca country... Vector vaccines make more sense and work better. Pfizer is useless against Omicron. I know more people who’ve had Covid than people who haven’t had Covid... I was around people who got Covid and the one thing they all had in common... They were shot with Pfizer mRNA shots... I was shot with AZ and didn’t get Covid... That’s not scientific... It’s reality.

That’s probably why America’s kill ratio is higher than most countries. The US kill ratio is 0.29% per million... India’s is 0.03% per million.

Even if India’s kill ratio is underestimated, they will never get to the United States kill percentages.

[jjotto]

India doesn’t have people like Cuomo, Murphy and Whitmer TRYING to kill people.

[dljordan]

” immunisation campaigns”

What are these vaccines making you immune to?

[JoanSmith]

India also used ivermectin.

[Worldtraveler once upon a time]

--- "That's probably why America's kill ratio is higher than most countries. The US kill ratio is 0.29% per million... India's is 0.03% per million."

I came across your post late in the posting cycle. I am amused by your choice of the descriptor -- kill ratio. Your citation of the "kill" in both countries is spot on.

As of 13 February 2022,

USA

( 942,944 worldometers-official deaths / 331,002,651 Americans ) x 100 = 0.285 % mortality rate

India

( 508,665 worldometers-official deaths / 1,380,004,385 Indians ) x 100 = 0.037 % mortality rate

Given the large disparity between the "kill ratios," one concludes that, over twenty-fiove months, the Fauci-led NIH, CDC and EUA-shielding FDA have "killed" at a higher rate than "third-world" India.

The Fauci-Pfizer-Moderna folks have been almost eight times the "killer" than India. Arithmetic.

So, as you write, "Even if India's kill ratio is underestimated, they will never get to the United States kill percentages," it seems your conclusion is VERY apt.

[Angelino97]

When I was a kid in the 1970s, we were told to eat all our food because children were starving in India.

I never thought I'd see the day when India's health care standards surpass that of the U.S.