NIH deleted report about monkeypox vaccine research in primates from 2004

[Emily]

https://thenationalpulse.com/2022/06/08/nih-erased-webpage-details-monkeypox-vaccine-bioterror-research-praised-by-anthony-fauci/

Exclusive
NIH Erased Webpage Details Monkeypox Vaccine ‘Bioterror’ Research Praised By Anthony Fauci.
by Natalie Winters
June 8, 2022

The deleted webpage detailed a study on a "mild, experimental smallpox vaccine known as modified vaccinia Ankara (MVA)" and how it is "nearly as effective as the standard smallpox vaccine in protecting monkeys against monkeypox."


The National Institutes of Health (NIH) deleted a webpage from 2004 detailing research into vaccine efficacy against the monkeypox virus which included Anthony Fauci praising the findings as “important” and referencing a potential “bioterror threat involving smallpox.”

The webpage can be accessed through an archived version of the National Institutes of Health (NIH) website, which reveals a press release from March 10th, 2004: “Effectiveness of Safer Smallpox Vaccine Demonstrated Against Monkeypox.”

When accessed, the link currently prompts users with the message “the page you’re looking for isn’t available.”...

From the archive:

https://web.archive.org/web/20150104204204/https://www.nih.gov/news/pr/mar2004/niaid-10.htm

National Institute of Allergy and Infectious Diseases (NIAID)

---

EMBARGOED FOR RELEASE Wednesday, March 10, 2004 1:00 p.m. ET E-mail this page Subscribe CONTACT: Jennifer Wenger 301-402-1663 Effectiveness of Safer Smallpox Vaccine Demonstrated Against Monkeypox A mild, experimental smallpox vaccine known as modified vaccinia Ankara (MVA) is nearly as effective as the standard smallpox vaccine in protecting monkeys against monkeypox, a study by researchers of the National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health, has found. Monkeypox is used to test the effectiveness of a smallpox vaccine because of its similarity to the smallpox virus. The study appears in the March 11 issue of Nature. "These findings are important to the search for a replacement vaccine for people with health conditions that would prevent them from using the current smallpox vaccine," says Anthony S. Fauci, M.D., director of NIAID. Currently, Dryvax is the only commercially available smallpox vaccine in the United States. "In addition, because an initial MVA injection may help lessen the side effects experienced from Dryvax, MVA may serve as an important pre-vaccine for large-scale vaccination efforts in the event of a bioterror threat involving smallpox." NIAID's Bernard Moss, M.D., Ph.D., the senior author on the paper, adds, "This study shows that the MVA vaccine holds great promise as an alternative to the current vaccine. Although MVA may not quite equal Dryvax in its effectiveness, it did extraordinarily well, with all of the monkeys who were vaccinated with MVA surviving a potentially lethal monkeypox infection and, aside from a few minor lesions, showing no clinical signs of disease." In a separate study published in the March 11 online early edition of the Proceedings of the National Academy of Sciences, Dr. Moss and colleagues found that, in addition to protecting healthy mice against a lethal form of the vaccinia virus, MVA protects mice with certain immune deficiencies as well. The researchers found that mice survived a deadly dose of vaccinia virus if they'd been immunized with MVA — even those mice that were lacking antibody-producing immune cells or special proteins that help alert killer T cells to an infection. The findings indicate that MVA may be a promising alternative to Dryvax in humans who are partially immunodeficient. Licensed in 1931, Dryvax is made from a live form of vaccinia virus that, although related to the smallpox virus, cannot cause smallpox. (Smallpox is caused by the more dangerous variola virus. The ability to prevent smallpox by injecting a person with either cowpox or vaccinia virus was demonstrated by Edward Jenner in the late 18th century.) Dryvax and similarly effective vaccines made in other countries led to the eradication of smallpox in 1980. While most reactions to the Dryvax vaccine are relatively mild, some people may have more serious complications. Individuals at risk for such complications include those with weakened immune systems or skin conditions such as eczema, infants less than 12 months of age and women who are pregnant. For this reason, a primary goal of health officials is to develop a vaccine that is as effective as Dryvax, but safer. MVA is a highly weakened form of the vaccinia virus that cannot multiply and infect mammalian cells. Although MVA was tested for safety in humans at the time of its development in Germany in the 1960s, it has not been tested for effectiveness against smallpox. According to the Food and Drug Administration, humans cannot be exposed to smallpox to test a vaccine's effectiveness: such exposure is unethical because smallpox is an infectious, deadly disease; and it is unfeasible because smallpox has been eradicated. Therefore, animal studies, such as those involving monkeys and mice, are critical to the development of a replacement vaccine. To compare MVA with Dryvax, the researchers divided 24 cynomologus monkeys (a type of monkey found in Southeast Asia, Borneo and the Philippines) into four groups of six. Group one received two MVA injections — one at the start of the study and the second two months later. Group two received the MVA vaccine at the start of the study and the Dryvax vaccine two months later. Group three received no injection at the start but received a Dryvax injection after two months. Group four, the control, received no vaccines. Immune responses were monitored throughout the immunization period, and then, later, after the monkeys were exposed to monkeypox. After vaccinating the monkeys, researchers examined the number of lesions that formed on the animals' skin and the amount of time in which they healed. Monkeys that received Dryvax alone developed the characteristic fluid-filled skin lesions, while those that received MVA prior to Dryvax had much smaller lesions. Furthermore, those that received MVA alone had no skin lesions. The researchers then looked for antibodies produced against two different forms of the poxvirus: intracellular mature virions (IMVs), virus particles thought to be responsible for transmitting the disease from one host to another; and extracellular enveloped virions, IMVs with an added outer membrane that play a large role in spreading the disease within the individual. To be effective, a vaccine needs to protect against both forms of the virus, and each form requires a different set of antibodies to destroy it. In addition to measuring antibodies, the scientists examined the production of killer T cells, special immune cells that attack cells already infected by the monkeypox virus. Dr. Moss and his research team discovered that the immune responses elicited by the MVA vaccine were similar to those produced by Dryvax in regard to both antibodies and killer T cells. Two months after the second vaccination, all 24 monkeys were exposed to monkeypox. Remarkably, all the immunized animals remained healthy with no signs of disease, except for a small number of lesions seen on several monkeys from the MVA-only group. The unvaccinated monkeys, however, had more than 500 lesions each and became seriously ill or died. Dr. Moss and his team will continue their studies on monkeys to determine, among other things, the duration of protection offered by MVA versus Dryvax as well as the effect of dosage. In addition, NIAID is currently supporting clinical trials to evaluate the immune response to MVA in humans. Other researchers involved in the study represented the Henry M. Jackson Foundation, Rockville, MD; the University of Pennsylvania, Philadelphia, PA; and the U.S. Army Medical Research Institute of Infectious Diseases, Frederick, MD. Smallpox is a serious, frequently fatal infectious disease that generally spreads from person to person through the air and is marked by fever, head and body aches, rash and large, fluid-filled bumps on the skin. The last case of smallpox in the United States occurred in 1949, and the last case in the world was in 1977. However, the smallpox virus still exists in laboratories and represents a potential threat because it could be used by terrorists. Monkeypox is primarily a disease of animals, but more than a hundred human cases a year have been reported from central and western Africa. The first monkeypox outbreak occurred in the United States in June 2003 when several people were sickened by infected pet prairie dogs. Symptoms of monkeypox are similar to smallpox, though often milder. NIAID is a component of the National Institutes of Health, an agency of the U.S. Department of Health and Human Services. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on transplantation and immune-related illnesses, including autoimmune disorders, asthma and allergies. Press releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov. References: PL Earl et al. Immunogenicity of a highly attenuated MVA smallpox vaccine and protection against monkeypox. Nature 428:182-5 (2004).LS Wyatt et al. Highly attenuated smallpox vaccine protects mice with and without immune deficiencies against pathogenic vaccinia virus challenge. Proceedings of the National Academy of Sciences DOI: 10.1073/PNAS.0401165101 (published online March 11, 2004).

I think this is why the page was deleted:

Two months after the second vaccination, all 24 monkeys were exposed to monkeypox. Remarkably, all the immunized animals remained healthy with no signs of disease, except for a small number of lesions seen on several monkeys from the MVA-only group.

So the new injectable vaccine was less effective than the old smallpox vaccine that is delivered via scarification of the skin with a bifurcated needle. Once again, we are going with the sole remedy of a vaccine that won't entirely prevent illness allowing vaccinated people to further spread the disease with few symptoms to warn others.

Here is a report from VAERS that indicates effectiveness of the new vaccines could be shorter than the old smallpox vaccines, too.

https://www.medalerts.org/vaersdb/findfield.php?IDNUMBER=2335638&WAYBACKHISTORY=ON

This is VAERS ID 2335638

Government Disclaimer on use of this data

History of Changes from the VAERS Wayback Machine

First Appeared on 7/1/2022

VAERS ID:	2335638
VAERS Form:	2
Age:
Sex:	Unknown
Location:	Foreign

Vaccinated:	2017-05-01
Onset:	2019-11-01
Submitted:	0000-00-00
Entered:	2022-06-27

Vaccination / Manufacturer (1 vaccine)	Lot / Dose	Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER	UNKNOWN / 2	- / OT

Administered by: Other Purchased by: ??
Symptoms: Vaccination failure, Monkeypox
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC 'Split Type': CDBAVARIAN NORDIC A/SCDBN
Write-up: The patient vaccinated with JYNNEOS in May and June 2017 developed Monkeypox in November 2019; The patient vaccinated with JYNNEOS in May and June 2017 developed Monkeypox in November 2019; Case reference number CD-BN-2022-001232 is a solicited case report initially received on 03-Jun-2022 from a physician and concerns an adult patient of unknown gender and age. The patient''s relevant medical history and concomitant medications were not provided. On an unspecified date in May-2017, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: not reported) at an unknown dose or anatomical location, administered subcutaneously for prevention of smallpox and monkeypox. On an unspecified date in Jun-2017, an unknown amount of time after the first dose, the patient was vaccinated with the second dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: not reported) at an unknown dose or anatomical location, administered subcutaneously. On an unspecified date in Nov-2019, approximately two years after vaccination with Jynneos, the patient developed monkeypox (explicitly coded as ''vaccination failure''). The outcome of the events was not provided. The events of ''vaccination failure'' and ''monkeypox'' were assessed as serious due to seriousness criteria of medically significance. Causality assessment was not reported. Additional information received on 08-Jun-2022 included local case ID.; Reporter''s Comments: An adult patient of unknown gender and age was vaccinated with two doses of Jynneos and approximately 29 months later, the patient developed monkeypox, which can be considered as vaccination failure. Monkeypox are unlisted for Jynneos, whilst vaccination failure is listed per company convention. The patient''s relevant medical history and concomitant medications were not provided. Having in mind the implausible temporal relationship, the causality for reported events is assessed as not related to Jynneos. The case is serious due to the medical significance of the events.; Sender''s Comments: An adult patient of unknown gender and age was vaccinated with two doses of Jynneos and approximately 29 months later, the patient developed monkeypox, which can be considered as vaccination failure. Monkeypox are unlisted for Jynneos, whilst vaccination failure is listed per company convention. The patient''s relevant medical history and concomitant medications were not provided. Having in mind the implausible temporal relationship, the causality for reported events is assessed as not related to Jynneos. The case is serious due to the medical significance of the events.

[Mary Wilson]

VAERS is co-sponsored by the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA), agencies of the U.S. Department of Health and Human Services (HHS).

This is VAERS ID 2335638

Government Disclaimer on use of this data

VAERS accepts reports of adverse events that occur following vaccination. Anyone, including Healthcare providers, vaccine manufacturers, and the public can submit reports to the system. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. Vaccine providers are encouraged to report any clinically significant health problem following vaccination to VAERS even if they are not sure if the vaccine was the cause. In some situations, reporting to VAERS is required of healthcare providers and vaccine manufacturers.

VAERS reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. Reports to VAERS can also be biased. As a result, there are limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.

The strengths of VAERS are that it is national in scope and can often quickly detect an early hint or warning of a safety problem with a vaccine. VAERS is one component of CDC's and FDA's multifaceted approach to monitoring safety after vaccines are licensed or authorized for use. There are multiple, complementary systems that CDC and FDA use to capture and validate data from different sources. VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also referred to as “safety signals.” If a possible safety signal is found in VAERS, further analysis is performed with other safety systems, such as the CDC’s Vaccine Safety Datalink (VSD) and Clinical Immunization Safety Assessment (CISA) Project, or in the FDA BEST (Biologics Effectiveness and Safety) system. These systems are less impacted by the limitations of spontaneous and voluntary reporting in VAERS and can better assess possible links between vaccination and adverse events. Additionally, CDC and FDA cannot provide individual medical advice regarding any report to VAERS.

Key considerations and limitations of VAERS data:

• The number of reports alone cannot be interpreted as evidence of a causal association between a vaccine and an adverse event, or as evidence about the existence, severity, frequency, or rates of problems associated with vaccines.
• Reports may include incomplete, inaccurate, coincidental and unverified information.
• VAERS does not obtain follow up records on every report. If a report is classified as serious, VAERS requests additional information, such as health records, to further evaluate the report.
• VAERS data are limited to vaccine adverse event reports received between 1990 and the most recent date for which data are available.
• VAERS data do not represent all known safety information for a vaccine and should be interpreted in the context of other scientific information.

VAERS data available to the public include only the initial report data to VAERS. Updated data which contains data from medical records and corrections reported during follow up are used by the government for analysis. However, for numerous reasons including data consistency, these amended data are not available to the public.

Additionally, reports to VAERS that appear to be potentially false or fabricated with the intent to mislead CDC and FDA may be reviewed before they are added to the VAERS database.

Knowingly filing a false VAERS report is a violation of Federal law (18 U.S. Code § 1001) punishable by fine and imprisonment.

https://vaers.hhs.gov/data.html

[Emily]

Additionally, reports to VAERS that appear to be potentially false or fabricated with the intent to mislead CDC and FDA may be reviewed before they are added to the VAERS database.

I think this report was reviewed by CDC. It seemed to be off the live data the first time I saw it, (that is why I used the archive link in my post.) Here is the live link now:

https://www.medalerts.org/vaersdb/findfield.php?IDNUMBER=2335638

The report looks credible, there was a trial that started in 2017 that the CDC sponsored. They project it to end in August.

https://clinicaltrials.gov/ct2/show/NCT02977715?term=NCT02977715&draw=2&rank=1

IMVAMUNE® Smallpox Vaccine in Adult Healthcare Personnel at Risk for Monkeypox in the Democratic Republic of the Congo

This paper looks related:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6438175/pdf/nihms-1009764.pdf

[Emily]

Still no results on the clinical trial. It has been a month and half since the trial was slated to end. Is this customary for it to take this long to publish findings? You would think this would be high priority given the outbreak and the fact that the vaccine is being used currently.

https://ichgcp.net/clinical-trials-registry/NCT02977715