Posted on 02/10/2021 5:00:32 PM PST by ebb tide
NDIA, February 10, 2021 (LifeSiteNews) – US-based COVID-19 vaccine maker Pfizer has withdrawn its application for emergency-use authorization of its product in India after the country’s health authorities demanded local safety testing.
India’s drug regulator last weekdeclined Pfizer’s request that its experimental COVID-19 mRNA vaccine “BioNTech” (BNT162b) be approved without a local trial of the product’s safety on the country’s population.
The country’s Central Drugs Standard Control Organisation formed a Subject Expert Committee that met on Feb. 3 to discuss Pfizer’s proposal for the emergency use authorization of its COVID-19 experimental vaccine.
“The committee noted that incidents of palsy, anaphylaxis and other SAE’s have been reported during post marketing and the causality of the events with the vaccine is being investigated,” the committee reported.
“Further, the firm [Pfizer] has not proposed any plan to generate safety and immunogenicity data in Indian population. After detailed deliberation, the committee has not recommended for grant of permission for emergency use in the country at this stage,” the committee added.
Pfizer in turn withdrew its application.
“Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time,” the company stated, as reported by Reuters.
“Pfizer will continue to engage with the authority and re-submit its approval request with additional information as it becomes available in the near future.”
India’s concerns about the safety of Pfizer’s mRNA gene-altering technology are not misplaced.
Data from the US-based National Vaccine Information Center shows that as of Jan. 29, there have been 501 deaths — a subset of 11,249 total adverse events — following COVID-19 vaccinations. Pfizer’s vaccine was taken by 59 percent of those who died while Moderna’s vaccine was taken by 41 percent.
The Norwegian Medicines Agency reported on Jan. 14 that twenty-three people died within days of receiving the first dose of Pfizer’s product.
California officials are investigating the Jan. 7 death of a 60-year-old healthcare worker who died four days after receiving his second injection of Pfizer’s product. A reportedly “perfectly healthy” 56-year-old Miami obstetrician died 16 days after receiving the Pfizer shot. State along with federal officials are investigating the Jan. 30 death of a 58-year-old Virginia woman who died hours after receiving the first dose of Pfizer’s vaccine.
America’s Frontline Doctors are urging the Biden administration to take note of India’s decision to deny Pfizer’s application based on a lack of safety.
“President Biden and his COVID-19 task force need to immediately and clearly explain to the American people why the Pfizer-BioNTech experimental vaccine is safe for Americans despite Indian drug regulators denying its emergency use based on concerns about potential side effects, immunogenicity, and other data,” the doctors’ group stated.
“The burden of proof should fall on the Biden White House to provide Americans with greater transparency and information so that they can make informed decisions about their own healthcare. Science should guide this administration’s COVID response plan not public relations, polls, and politics.”
While India has rejected Pfizer’s vaccine, it has approved the use of Oxford University’s AstraZeneca vaccine and another one developed on home soil by Bharat Biotech with the Indian Council of Medical Research, reports Reuters.
LifeSiteNews has produced an extensive COVID-19 vaccines resources page. View it here.
Which would of course be the obvious reason. But logic does not prevail on the rabidly antivaxx threads
Because they are safe, and you should take them.
“Incorrect, as usual. Over the top accusations and pejoratives to deflect from the fact that the founders of this group believe:
1. Gynecological disease is caused by women having sex with demons in their dreams (do you believe that this is credible, it appears you are defending them)
2. Klan is a pejorative to conjure up racism, apparently you intent?
3. You choose not to address that the majority of physicians have distanced themselves from this fringe group.
I am not suggesting censorship (another grow mischaracterization) but brining to light that which the group you wish for us to take as gospel truth espouses.
Would you like to answer on point, or shall I simply prepare for more meaningless insults that are nothing more than full or sound and fury signifying a lack of a rational argument?
My my, a wee bit sensitive are we?
Yep. Watched it the other day.
I’ll let everyone else rush to the front of the vax line.
Who knows these days.
With the way things are going, the “vaccines” could be contaminated water billed as a vaccine and funds for vaccine pocketed by execs.
And why not, that IS the Soviet way.
Not sensitive at all, just checking if you support these statements from the group that you quote. I would love to hear you defend these statements.
Do you believe them to be correct?
“Because they are safe, and you should take them.”
Yes! Take the damn vaccines and quit asking questions!
Thats what they told the Tuskegee Airmen and the Viet Nam Vets.
But hey, it must surely be safe if Doctor Gas says it is. Right?
Btw, any relation to. Eric Swallwell?
The height of ironies is your tagline, and I quote....
Trial lawyers AND POLITICIANS are Endangering Every Patient in America: INCLUDING THEIR LIBERTIES
So I would assume your against mandatory vaccines? Or isn’t that a liberty you defend?
Another pointless smear.
However, as stated, Pfizer and Moderna were each tested in Clinical trials Phases 1 - 3 on over 100,000 volunteer subjects per each vaccine and demonstrated 94% and 95% efficacy in preventing disease and 100% efficacy in preventing severe disease and death.
In Tuskagee, the airmen where not informed of what was occurring which is clear breach of informed consent. So if you choose to draw an equivalency, kindly make sure that the equivalency is valid.
So, I ask you, are you intentionally bringing up untrue comparisons because of the malignant need to be right, or the sadistic need to control the lives of other and prevent them from choosing studied and proven life saving vaccines?
Please answer directly, if you are capable of doing so.
If you have researched my posts and my opinion, I am absolute against mandatory vaccine, exactly as I am against you using false information to attempt to force your perspective upon people.
Of course, if you simply looked things up instead of smearing me, you would have not asked this question that makes you look rather foolish.
The question you might ask is: do the governments of India and China have a problem with 80 year olds
So, as you continue to ask me questions and I answer on point and directly, do you agree with the founders of American Frontline Doctors that various diseases are caused by people of having sex with demons in their dreams?
Please, answer. We deserve to know if you agree with these statements, as you defend this group vociferously.
I know what you meant, but then again, I can understand nuance in conversation.
Been re-reading The Hunt for Red October?
The thing I keep running up against is that I can not take Big Whatevers word for anything. I was always suspicious but now I have firmly moved into paranoid territory.
I’d say no more so than Gov. Cuomo...
But why are these governments, including ours, demanding all adults, regardless of age, be vaccinated?
But still, you aren't on the Nut-Job Conspiracy ping list...
Actually, been looking at what the adjuvant agents in some vaccines are.
If you were really paranoid, you might think that a vaccine that doesn’t convey immunity might set up the recipients for a cytokine storm when infected, or perhaps anaphylactic shock?
Come to the dark side we have cookies, and web trackers...
“However, as stated, Pfizer and Moderna were each tested in Clinical trials Phases 1 - 3 on over 100,000 volunteer subjects per each vaccine and demonstrated 94% and 95% efficacy in preventing disease and 100% efficacy in preventing severe disease and death.”
Now where have I heard such proponents for unapproved big pharma? I know, it was the last big pharma lobbiest I spoke with.
“In Tuskagee, the airmen where not informed of what was occurring which is clear breach of informed consent. So if you choose to draw an equivalency, kindly make sure that the equivalency is valid.”
Tuskegee Airmen were used as guinni pigs for experimentation purposes. Connect the dots. Even you can do that.
“So, I ask you, are you intentionally bringing up untrue comparisons because of the malignant need to be right, or the sadistic need to control the lives of other and prevent them from choosing studied and proven life saving vaccines?”
I’m not the one promoting vaccines that lack fda approval and receive a lot of $ for a product they are granted full immunity from liability. Perhaps that’s the type of informed consent you were implying? Heres a hint, you can cite all the statistics you want but when major testing phases are bypassed (unprecedented btw) then its lacking confidence for the consumer.
“Please answer directly, if you are capable of doing so.”
Theres my direct response. Enjoy
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