Pfizer Withdraws EUA Application for COVID Shot in India After Regulator Asks for Independent Safety Study

Pfizer Withdraws EUA Application for COVID Shot in India After Regulator Asks for Independent Safety Study

Pfizer, Inc. has withdrawn its emergency use authorization (EUA) application for its experimental BNT162b2 (also known as “Comirnaty”) messenger RNA (mRNA) COVID-19 biologic (developed in collaboration with Germany’s BioNTech) in India.1

Pfizer was the first pharmaceutical company to apply for an EUA to distribute a COVID biologic in India in 2021. However, India’s regulatory agency approved two other COVID vaccines that are more cost effective: AstraZeneca/Oxford University’s experimental AZD1222 vaccine and the locally-manufactured BBV152 (“Covaxin”) vaccine by Bharat Biotech.2

During Pfizer’s meeting with India’s drug regulatory agency, the Central Drugs Standard Control Organization (CDSCO), the pharmaceutical decided to withdraw its application after the regulator requested a local trial on the vaccine’s safety and immunogenicity specifically for Indians.3

After a meeting with Pfizer officials, CDSCO said, “After detailed deliberation, the committee has not recommended grant of permission for emergency use in the country at this stage.”4

Pfizer Refused to Conduct Local Safety Trial for Its COVID Biologic Before Being Denied EUA in India

In order for the CDSCO to grant Pfizer an EUA for BNT162b2, the drugmaker was required to conduct a local clinical trial in India to determine if the vaccine is safe and generates an adequate immune response in its citizens.5

Vinod K. Paul, head of India’s government panel on vaccine strategy said that all foreign developed vaccines have to undergo a “bridging trial” in India in order to receive approval. A “bridging trial” is required to determine the immune response and safety record of the vaccine in population with a different genetic makeup than in Western nations.6

Pfizer applied for an exemption from India’s “bridging trial” requirement by citing that it has received EUA approvals in other countries based on clinical trials conducted in the United States and Germany. Although there are provisions under India’s law to waive the requirements of “bridging trials” in certain circumstances, India’s regulatory agency decided not to waive the requirement for BNT162b2.7

The CDSCO’s website states:

The firm presented its proposal for emergency use authorization of COVID19 mRNA Vaccine BNT162b before the committee. 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. Further, the firm 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.8

Since BNT162b2 must be stored at a low temperature of minus 94 Fahrenheit, Indian Health Ministry officials said that the biologic is not the best option for the country given that it requires expensive freezers that are not readily available in India.9

Currently, a local pharmaceutical company in India known as Dr. Reddy’s Laboratories is conducting a “bridging trial” for Russia’s COVID vaccine called Sputnik Light (a component of Sputnik V) developed by Moscow’s Gamaleya Institute of Epidemiology and Microbiology, which is expected to be approved for EUA in India.10


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7 Responses to "Pfizer Withdraws EUA Application for COVID Shot in India After Regulator Asks for Independent Safety Study"

  1. Colorado   February 22, 2022 at 8:16 pm

    Hmmmm…. Not ready for third party independent testing… Let us count the ways this could just possibly be related to suspicious untrustworthy behavior… Hmmmmm….. Sometimes obvious is obvious and that’s all you need to know.

    Meanwhile my 78 year old uncle must have had some vertigo or something because he straight fell down the stairs and now is on hospice care. He’ll probably never go home again. I warned them not to take the vaccine but the power of the propaganda was too great. My grandpa has cancer they won’t even bother to treat, my grandmother has sudden onset dimensia and refers to the wrong people with the wrong name. My dad has brain fog and my uncle may very well have had a known side effect of a combination of effects which led to a fall. My father in law has sudden failures in his health and diabetes. My wife whom works on the hospital phones has commented on a sudden uptick in side effect related concerns, heart problems, blood clotting being the two most notable and common call in items. She always states this is a known side effect of the covid vaccine but people just can’t get their minds around it nor do they care to. The just say; no it could not be that, the vaccines are safe and effective… Then the am radio guys hit me with some nobel prize winner statement that the vaccinated have no way out and most of them are on a ticking clock where their life expectancy will probably not exceed 2-5 years. Then just yesterday I watched a german translation video where they did high magnification blood drop tests on glass slides, 4 vaxxed, 4 not, and every one of the vaxxed blood samples had clotting, grouping, sticky blood, chained up red cells, highly unusual structures and foreign substances in just that tiny drop from their fingers. They showed some parasitic worms hatching from micro eggs in a dried vaccine sample alongside what looked like sharp micro object contamination and unusual grouping of particulates to geometric shapes. Volunteers all watched each others results and the vaxxed participants reportedly were crying. The first recommendation was superdosing vitamin C and there is speculation they’ll need ivermectin like life support if they want to survive the next decade. Guest doctors on talk shows are on about the sad indications the rnma re sequencing effect is not waning and may be growing stronger over time even without boosters… Tell your story if you want but many of us have received enough information now that we’re absolutely positioned that we do not want any vaccines what so ever from this point forward, of any and all types. The fear for the unvaccinated is that the vaccinated are shedding dangerous prions which may in turn render ourselves and our precious children infertile. We need information on spontaneous transference and mutagenic cross over due to shedding even without accepting the vaccine and we need it now! Love will never be the same for the younger generation, they’ll have to pass based on vaccination status no matter how strong or meaningful the personal attractions may be. And the fact the unvaccinated are routinely exposed to the vaccinated whom are shedding molecules which could uptake into other biological hosts then recreate the rnma resequensing activity is a serious issue that needs addressed immediately. But as long as you repeat this slogan you’ll be fine; Safe and Effective! Safe and Effective! Squaaaaaaaak! We’re back to superdosing vitamins for preventative measures. And now the bureaucrats have whipped out their magic ball and proclaimed natural immunity only lasts 3 months and we’ll have to review lockdown and safety measures again this June at least. They’re signaling they’ll be rolling this all forward again just in time for school starting just like last year. Idiots. Strap in because this is just getting started.

    Reply
    • Arel   February 23, 2022 at 8:40 am

      Exactly right, one of my dear friends grandmother got the vaccine and now has permanent nerve damage and is constant pain; her doctor told her there is nothing they can do to remedy it.

      Reply
  2. Tom   February 22, 2022 at 8:35 pm

    That’s because there are no safety studies and there never will be. You needn’t wonder why.

    Reply
  3. Vijay Gupta   February 22, 2022 at 10:13 pm

    This is good news for Indians. They have better vaccine choices than Pfizer’s mRNA vaccine. Vaccines approved in India are less expensive, safer, and equally (or more) effective. They are also easier to store at typical fridge temperatures.

    Moreover, if there are long-term side effects of the mRNA vaccines in the US, one will be able to study them by using people from countries like India for comparison.

    Reply
  4. Melinda G. Gladstone   February 23, 2022 at 6:43 am

    Really? Why? They are “SAFE & EFFECTIVE” as we are told!!!

    Reply
  5. Susan   February 23, 2022 at 7:21 pm

    Did the Astrazeneca mrna vaccine have a full bridging safety study in India? Based on this artcle, it was approved with minimal interim results and the India designed covid vaccine was approved before it had even completed Phase 3 clinical trials:

    https://www.science.org/content/article/scientists-criticize-rushed-approval-indian-covid-19-vaccine-without-efficacy-data

    The side effects for the Astrazeneca were a bit worse than the Pfizer mrna vaccine. That’s why Astrazeneca’s vaccine testing in the US was halted over a year ago and that vaccine was never approved in the US.

    So was Astrazeneca’s vaccine approved in India because it was cheaper? Was it approved before completion of their bridging study? If so, then why did they get a waiver and not Pfizer? Could it be money and politics were major factors?

    Doing an additional bridging study obviously takes time and costs money. Has there ever been a vaccine that had different effectiveness and different side effects in western countries and the US compared to residents in India? Are there antibiotics that work on Americans, Italians, French, Swiss, Japanese, Africans, but don’t work on India residents?

    There are other countries who want Pfizer’s vaccine and it sounds like India might not have approved it due to other factors.

    Reply
  6. DJ Cikla   March 3, 2022 at 2:25 pm

    To Susan.The AstraZeneca vaccine is a viral vector vaccine, not mRNA. The Pfizer vaccine was still in the phase III study when given EUA and was approved as a Comirnaty without the release of the long term study results of the efficacy and safety. FDA asked for 75 years to release the study data publicly. By court order, they will have to in only 8 months. Remember that they managed to review and EUAuthorize it in barely two months. Pfizer also unblinded the participants, giving the placebo group the vaccine before finishing the study, a reason being that it would be unethical not to protect the control group. Wouldn’t you think something like this would be known to a reasonable scientists before the trials began? Well they had to start giving boosters as they admitted that the vaccine efficacy waned in a few months. And last, but not least, would you or anybody else personally really know it after the vax you developed the needed antibodies? It is like taking the high blood pressure pills, but never rechecking if the pill really lowered the blood pressure.

    Reply

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