Categories
News

FDA report finds all-cause mortality higher among vaccinated – Israel Nation News

FDA report shows Pfizer’s clinical trials found 24% higher all-cause mortality rate among the vaccinated compared to placebo group.

The clinical trials of Pfizer’s coronavirus vaccine found that the all-cause mortality rate of the vaccinated group was higher than that of the control group, months after the trials were launched, according to a recently released FDA report.

According to the report, which was released by the US Food and Drug Administration to provide background information on its August 2021 decision to grant full approval for the Pfizer-BioNTech coronavirus vaccine after offering limited emergency authorization of use in last December, six months after the vaccine’s clinical trial began, the total number of deaths reported in the vaccinated group was nearly one-quarter higher than the number of deaths in the placebo group.

http://archive.today/2021.11.19-040650/https://www.israelnationalnews.com/News/News.aspx/317091

Categories
Videos

Pfizer trials did not show a reduction in deaths – Peter Doshi, PhD, Editor of BMJ

Peter Doshi, PhD, is an editor of the BMJ and on the faculty of the University of Maryland.

  • Most hopitalisations in the UK are among the fully vaccinated
  • Pfizer trials did not show a reduction in deaths–the evidence is flimsy
  • These mRNA products are qualitatively different from standard vaccines
  • The definitions for vaccines ahve changed
  • We shouldn’t assume the new [mRNA products] are like other childhood vaccines which get mandated [in the US]

This is a short clip of the video archive at: https://evidencenotfear.com/vaccine-mandates-expert-panel-highlights-senator-ron-johnson/

Vaccine Mandates Expert Panel Highlights on Senator Ron Johnson’s channel.

Categories
Publications

November 8, 2021 Summary Basis for Regulatory Action – Comirnaty – FDA

Introduction

BioNTech Manufacturing GmbH (in partnership with Pfizer Inc.) submitted a Biologics License Application (BLA) STN BL 125742 for licensure of COVID-19 Vaccine, mRNA. The proprietary name of the vaccine is COMIRNATY. COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The vaccine is administered intramuscularly (IM) as a series of two 30 μg doses (0.3 mL each) 3 weeks apart.

For commentary, see FDA report finds all-cause mortality higher among vaccinated – Israel Nation News.

http://archive.today/2021.10.11-032110/https://www.fda.gov/media/151733/download

Categories
Publications

Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial – BMJ

Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports

In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1

But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.

Poor laboratory management
On its website Ventavia calls itself the largest privately owned clinical research company in Texas and lists many awards it has won for its contract work.2 But Jackson has told The BMJ that, during the two weeks she was employed at Ventavia in September 2020, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues. Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years’ experience in clinical research coordination and management. Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. Another showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants. Ventavia executives later questioned Jackson for taking the photos.

Early and inadvertent unblinding may have occurred on a far wider scale. According to the trial’s design, unblinded staff were responsible for preparing and administering the study drug (Pfizer’s vaccine or a placebo). This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts.

In a recording of a meeting in late September2020 between Jackson and two directors a Ventavia executive can be heard explaining that the company wasn’t able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control. “In my mind, it’s something new every day,” a Ventavia executive says. “We know that it’s significant.”

Ventavia was not keeping up with data entry queries, shows an email sent by ICON, the contract research organisation with which Pfizer partnered on the trial. ICON reminded Ventavia in a September 2021 email: “The expectation for this study is that all queries are addressed within 24hrs.” ICON then highlighted over 100 outstanding queries older than three days in yellow. Examples included two individuals for which “Subject has reported with Severe symptoms/reactions … Per protocol, subjects experiencing Grade 3 local reactions should be contacted. Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate.” According to the trial protocol a telephone contact should have occurred “to ascertain further details and determine whether a site visit is clinically indicated.”

Worries over FDA inspection
Documents show that problems had been going on for weeks. In a list of “action items” circulated among Ventavia leaders in early August 2020, shortly after the trial began and before Jackson’s hiring, a Ventavia executive identified three site staff members with whom to “Go over e-diary issue/falsifying data, etc.” One of them was “verbally counseled for changing data and not noting late entry,” a note indicates. At several points during the late September meeting Jackson and the Ventavia executives discussed the possibility of the FDA showing up for an inspection (box 1). “We’re going to get some kind of letter of information at least, when the FDA gets here . . . know it,” an executive stated.

Box 1
A history of lax oversight
When it comes to the FDA and clinical trials, Elizabeth Woeckner, president of Citizens for Responsible Care and Research Incorporated (CIRCARE),3 says the agency’s oversight capacity is severely under-resourced. If the FDA receives a complaint about a clinical trial, she says the agency rarely has the staff available to show up and inspect. And sometimes oversight occurs too late.

In one example CIRCARE and the US consumer advocacy organisation Public Citizen, along with dozens of public health experts, filed a detailed complaint in July 2018 with the FDA about a clinical trial that failed to comply with regulations for the protection of human participants.4 Nine months later, in April 2019, an FDA investigator inspected the clinical site. In May this year the FDA sent the triallist a warning letter that substantiated many of the claims in the complaints. It said, “[I]t appears that you did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects.”5

“There’s just a complete lack of oversight of contract research organisations and independent clinical research facilities,” says Jill Fisher, professor of social medicine at the University of North Carolina School of Medicine and author of Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials.

Ventavia and the FDA
A former Ventavia employee told The BMJ that the company was nervous and expecting a federal audit of its Pfizer vaccine trial.

“People working in clinical research are terrified of FDA audits,” Jill Fisher told The BMJ, but added that the agency rarely does anything other than inspect paperwork, usually months after a trial has ended. “I don’t know why they’re so afraid of them,” she said. But she said she was surprised that the agency failed to inspect Ventavia after an employee had filed a complaint. “You would think if there’s a specific and credible complaint that they would have to investigate that,” Fisher said.

In 2007 the Department of Health and Human Services’ Office of the Inspector General released a report on FDA’s oversight of clinical trials conducted between 2000 and 2005. The report found that the FDA inspected only 1% of clinical trial sites.6 Inspections carried out by the FDA’s vaccines and biologics branch have been decreasing in recent years, with just 50 conducted in the 2020 fiscal year.7


The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizer’s clinical trial at Ventavia. She then reported her concerns in an email to the agency. In the afternoon Ventavia fired Jackson—deemed “not a good fit,” according to her separation letter.

Jackson told The BMJ it was the first time she had been fired in her 20 year career in research.

Concerns raised
In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. The full trial (registered under NCT04368728) enrolled around 44 000 participants across 153 sites that included numerous commercial companies and academic centres. She then listed a dozen concerns she had witnessed, including:
-Participants placed in a hallway after injection and not being monitored by clinical staff
-Lack of timely follow-up of patients who experienced adverse events
-Protocol deviations not being reported
-Vaccines not being stored at proper temperatures
-Mislabelled laboratory specimens, and
-Targeting of Ventavia staff for reporting these types of problems.
Within hours Jackson received an email from the FDA thanking her for her concerns and notifying her that the FDA could not comment on any investigation that might result. A few days later Jackson received a call from an FDA inspector to discuss her report but was told that no further information could be provided. She heard nothing further in relation to her report.

In Pfizer’s briefing document submitted to an FDA advisory committee meeting held on 10 December 2020 to discuss Pfizer’s application for emergency use authorisation of its covid-19 vaccine, the company made no mention of problems at the Ventavia site. The next day the FDA issued the authorisation of the vaccine.8

In August this year, after the full approval of Pfizer’s vaccine, the FDA published a summary of its inspections of the company’s pivotal trial. Nine of the trial’s 153 sites were inspected. Ventavia’s sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation. The FDA’s inspection officer noted: “The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug].”

Other employees’ accounts
In recent months Jackson has reconnected with several former Ventavia employees who all left or were fired from the company. One of them was one of the officials who had taken part in the late September meeting. In a text message sent in June the former official apologised, saying that “everything that you complained about was spot on.”

Two former Ventavia employees spoke to The BMJ anonymously for fear of reprisal and loss of job prospects in the tightly knit research community. Both confirmed broad aspects of Jackson’s complaint. One said that she had worked on over four dozen clinical trials in her career, including many large trials, but had never experienced such a “helter skelter” work environment as with Ventavia on Pfizer’s trial.

“I’ve never had to do what they were asking me to do, ever,” she told The BMJ. “It just seemed like something a little different from normal—the things that were allowed and expected.”

She added that during her time at Ventavia the company expected a federal audit but that this never came.

After Jackson left the company problems persisted at Ventavia, this employee said. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Laboratory confirmed symptomatic covid-19 was the trial’s primary endpoint, the employee noted. (An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19.)

“I don’t think it was good clean data,” the employee said of the data Ventavia generated for the Pfizer trial. “It’s a crazy mess.”

A second employee also described an environment at Ventavia unlike any she had experienced in her 20 years doing research. She told The BMJ that, shortly after Ventavia fired Jackson, Pfizer was notified of problems at Ventavia with the vaccine trial and that an audit took place.

Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial; NCT04816643, NCT04754594, NCT04955626, NCT05035212). The advisory committee for the Centers for Disease Control and Prevention is set to discuss the covid-19 paediatric vaccine trial on 2 November.

Footnotes
Provenance and peer review: commissioned; externally peer reviewed.

Competing interests: PDT has been doubly vaccinated with Pfizer’s vaccine.

This article is made freely available for use in accordance with BMJ’s website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.

https://bmj.com/coronavirus/usage

References
* Bourla A. An open letter from Pfizer chairman and CEO Albert Bourla. Pfizer. https://www.pfizer.com/news/hot-topics/an_open_letter_from_pfizer_chairman_and_ceo_albert_bourla.
* Ventavia. A leading force in clinical research trials. https://www.ventaviaresearch.com/company.
* Citizens for Responsible Care and Research Incorporated (CIRCARE). http://www.circare.org/corp.htm.
* Public Citizen. Letter to Scott Gottlieb and Jerry Menikoff. Jul 2018. https://www.citizen.org/wp-content/uploads/2442.pdf.
↵Food and Drug Administration. Letter to John B Cole MD. MARCS-CMS 611902. May 2021. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jon-b-cole-md-611902-05052021.
* Department of Health and Human Services Office of Inspector General. The Food and Drug Administration’s oversight of clinical trials. Sep 2007. https://www.oig.hhs.gov/oei/reports/oei-01-06-00160.pdf.
* Food and Drug Administration. Bioresearch monitoring. https://www.fda.gov/media/145858/download.
* FDA takes key action in fight against covid-19 by issuing emergency use authorization for first covid-19 vaccine. Dec 2020. https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19.

Original article: https://www.bmj.com/content/375/bmj.n2635

Archive mirrors:

Categories
News

What is the Number Needed to Vaccinate (NNTV) to prevent a single COVID-19 fatality in kids 5 to 11 based on the Pfizer EUA application? Toby Rogers, Ph.D.

An article by Toby Rogers, Ph.D.

I was reading the CDC’s “Guidance for Health Economics Studies Presented to the Advisory Committee on Immunization Practices (ACIP), 2019 Update” and I realized that the FDA’s woeful risk-benefit analysis in connection with Pfizer’s EUA application to jab children ages 5 to 11 violates many of the principles of the CDC’s Guidance document. The CDC “Guidance” document describes 21 things that every health economics study in connection with vaccines must do and the FDA risk-benefit analysis violated at least half of them.

Today I want to focus on a single factor: the Number Needed to Vaccinate (NNTV). In four separate places the CDC Guidance document mentions the importance of coming up with a Number Needed to Vaccinate (NNTV). I did not recall seeing an NNTV in the FDA risk-benefit document. So I checked the FDA’s risk-benefit analysis again and sure enough, there was no mention of an NNTV.

http://archive.today/2021.11.01-110110/https://tobyrogers.substack.com/p/what-is-the-number-needed-to-vaccinate

Categories
Opinion

Vaccine Control Group – The Mind Renewed with Julian Charles

Julian Charles of The Mind Renewed podcast interviews Diny Fielder-van Kleeff from The Vaccine Control Group.

We are joined by the author Diny Fielder-van Kleeff, co-founder of the Vaccine Control Group—or, more fully, the SARS-CoV-2 Vaccine Control Group—for an in-depth interview on the aims and objectives of this intriguiging and potentially highly significant “community cooperative” study.

“The Vaccine Control Group is a worldwide independent long-term study that is seeking to provide a baseline of data from unvaccinated individuals for comparative analysis with the vaccinated population, to evaluate the success of the Covid-19 mass vaccination programme and assist future research projects. This study is not, and will never be, associated with any pharmaceutical enterprise as its impartiality is of paramount importance. The VaxControlGroup is a community cooperative, for the people. All monies raised will be re-invested into the project and its community.”—VaxControlGroup

https://www.themindrenewed.com/interviews/2021/1446-int-197

Categories
News

Coronavirus Vaccine Tracker – The New York Times

Vaccines typically require years of research and testing before reaching the clinic, but in 2020, scientists embarked on a race to produce safe and effective coronavirus vaccines in record time. Researchers are currently testing 100 vaccines in clinical trials on humans, and 32 have reached the final stages of testing. More than 75 preclinical vaccines are under active investigation in animals.

http://archive.today/2021.08.28-041810/https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html

Categories
Publications

“He who pays the piper calls the tune”: Researcher experiences of funder suppression of health behaviour intervention trial findings – PLOS ONE

Background
Governments commonly fund research with specific applications in mind. Such mechanisms may facilitate ‘research translation’ but funders may employ strategies that can also undermine the integrity of both science and government. We estimated the prevalence and investigated correlates of funder efforts to suppress health behaviour intervention trial findings.

Conclusions
One in five researchers in this global sample reported being pressured to delay, alter, or not publish the findings of health behaviour intervention trials. Regulation of funder and university practices, establishing study registries, and compulsory disclosure of funding conditions in scientific journals, are needed to protect the integrity of public-good research.

http://archive.today/2021.08.26-220224/https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0255704

Categories
Videos

Dr. Tess Lawrie Interview – Oracle Films

Dr. Tess Lawrie is a world-class researcher and consultant to the World Health Organisation. Her biggest clients happen to be those who are involved in the suppression of repurposed drugs. She has decided to speak out in protest against the current medical establishment at considerable personal risk.

She co-founded the BiRD Group; an international consortium of experts dedicated to the transparent and accurate scientific research of Ivermectin, with particular emphasis on the treatment and prevention of Covid-19.

Categories
Alternative Media Opinion Videos

Dr. Robert Malone Interview – Inventor Of mRNA Technology Censored For Speaking Out On Vaccine Risks – The Last American Vagabond

Dr. Robert Malone, inventor of the mRNA technology used in the COVID-19 injections, discusses his concerns over their safety and how concerns are censored. 

  • “I have been written out of history.”
  • The chairman of the board of Reuters sits on the board of Pfizer.
  • The conflicts of interests are overt…it’s in your face…they have no shame.
  • The big thinkers in the government envy the Chinese model of government.
  • The political spectrum is irrelevant [on the topic of COVID and vaccines].
  • These discussions are forbidden talk so we won’t get to the truth.
  • Detailed discussion on the cytotoxic effects of spike proteins and safety of the new mRNA COVID vaccines at around 40mins.
  • Dr. Malone agrees with many of Dr. Mike Yeadon‘s comments, except Dr. Yeadon’s conclusion of a conspiracy.
  • The figure of 70% uptake of vaccines to reach herd immunity was made up. The data isn’t known. “Somebody is just pulling it out of the air.”
  • The vaccines don’t stop you from getting the virus or spreading it.
  • The early trials were designed to optimise success.
  • You cannot publish stuff outside of the approved memes and that means we can’t do science. People are dying because of this.
  • Other treatments have been suppressed to increase uptake of the vaccine.
  • The fear is bringing out social pathologies and is diminishing our ability to think.
  • We’ve had rampant groupthink in the government, in the WHO and across the world.
  • “I’ve never seen this level of co-ordinated crazy.”
  • “I’m concerned about what’s at the other side of the tunnel.”
  • The new COVID-19 vaccines are still experimental.
  • “Most of us who haven’t drunk the Koolaid” say the risk of COVID to children is remarkably low and the risk of vaccines is not nothing.
  • There is no logic in vaccinating children, adolescents and young adults. There are some risk and they’re not trivial.

Source links can be found at The Last American Vagabond.

Categories
News

Covid: Ivermectin to be studied as possible treatment in UK – BBC News

University of Oxford scientists are trialling giving Ivermectin to over-50s with Covid symptoms to see if it can keep them out of hospital.

http://archive.today/2021.06.23-080235/https://www.bbc.com/news/health-57570377

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News

Pfizer begins testing its Covid vaccine in children aged 5-11 as Moderna CEO says his company’s shot for kids will be available by the early fall – Daily Mail

Pfizer-BioNTech announced on Tuesday they have begun late-stage clinical trials of their coronavirus vaccine in children ages five to 11

Lower doses will be used for kids, 10 micrograms, compared to the 30 micrograms that those ages 12 and above receive

The company says it is hoping for data in the latter half of 2021, and is still in the early stages for trials in children between six months to four years old

On Monday, Moderna CEO Stéphane Bancel said he believes his company’s vaccine will be available for kids as young as five years old by early fall

Parents and doctors have been debating about whether or not to inoculate children because they make up just 0.1% of all COVID deaths

https://www.dailymail.co.uk/health/article-9664191/Pfizer-begins-testing-Covid-vaccine-children-ages-5-11.html

Categories
Opinion

Child vaccination implications for fully informed consent – HART

HART continues to be deeply concerned to hear various MPs and SAGE representatives calling for children to be vaccinated against COVID-19 despite the lack of long-term safety data. Disturbing language has been used by teaching unions implying that the use of ‘peer pressure’ could be harnessed to boost take up among school children, even though such coercion would be unethical, not to mention contrary to UK and International Laws and Declarations.

Categories
Publications

Risk in Vaccine Research and Development Quantified – PLOS ONE

Published in 20th March 2013

A database was actively compiled to include all vaccine projects in development from 1998 to 2009 in the pre-clinical development phase, clinical trials phase I, II and III up to Market Registration. The average vaccine, taken from the preclinical phase, requires a development timeline of 10.71 years and has a market entry probability of 6%. Stratification by disease area reveals pandemic influenza vaccine targets as lucrative.

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0057755

Categories
Publications

The four phases of clinical trials – Pfizer

The process of learning about and developing an investigational medicine is divided into four phases. At first, very few people receive the medicine being studied. The number of people participating in clinical studies grows along with our understanding of the investigational medicine, and the research continues as long as the potential benefits outweigh the risks.

https://www.pfizer.com/science/clinical-trials/guide-to-clinical-trials/phases

Categories
News

Were fears of a third wave overblown? – The Spectator

So, the third wave is officially no more. New modelling by SPI-M, the government’s committee on modelling for pandemics, has, at a stroke, eradicated the predicted surge in new infections, hospital admissions and deaths which it had pencilled in for the autumn or winter as a result of lockdown being eased. 

…As Philip Thomas explained here on Sunday, Imperial College has also assumed strangely low estimates for the number of people in Britain carrying antibodies. If you are going to use assumptions that are far more pessimistic than real world data suggests, it is small wonder that SPI-M keeps predicting waves and surges that turn out to be wide of the mark. The question is: why are these modelling teams using such negative assumptions?

https://www.spectator.co.uk/article/how-likely-is-a-third-wave-

Categories
News

Healthy children simply do not need a Covid jab – The Telegraph

I won’t have been the only parent concerned by news last week that the Pfizer vaccine may be approved for use on children as early as June and potentially rolled out to school pupils from September. Healthy children are at almost no serious risk from Covid-19 – the recovery rate for this age group has been calculated at over 99.99 per cent. The argument that children should have the vaccine is not based on a belief that they need or benefit from it but on the logic that it would be good for our communities at large if children were jabbed. In short, those advocating it assume that children have an obligation to protect adults.

It’s worth noting that the UK Government has granted immunity from liability for harms to all Covid-19 vaccine manufacturers. Can we really ask children to accept a greater risk than the manufacturers themselves are prepared to live with?

https://www.telegraph.co.uk/news/2021/05/03/healthy-children-simply-do-not-need-covid-jab

Categories
Publications

Vaccine Development, Testing, and Regulation – The History of Vaccines

Vaccine development is a long, complex process, often lasting 10-15 years and involving a combination of public and private involvement.

https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation

Categories
News

The shock and reality of catching COVID after being vaccinated – NPR

Robin Hauser, a pediatrician in Tampa, Florida, got COVID in February. What separates her from the vast majority of the tens of millions of other Americans who have come down with the virus is this: She got sick seven weeks after her second dose of the Pfizer-BioNTech vaccine.

https://www.pbs.org/newshour/health/the-shock-and-reality-of-catching-covid-after-being-vaccinated

Categories
Publications

NIAID Statement on AstraZeneca Vaccine

Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.

https://www.nih.gov/news-events/news-releases/niaid-statement-astrazeneca-vaccine