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Guest CIDRAP

H1N1 vaccine safety similar to seasonal vaccines

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Guest CIDRAP

The 2009 H1N1 influenza vaccine generated more adverse-event reports than recent seasonal flu vaccines, but this was probably due in part to heavy publicity, and the vaccine's safety profile appears similar to that of seasonal vaccines, according to a new analysis by federal scientists.

 

The researchers, from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), found that serious adverse events (AEs)—particularly Guillain-Barre syndrome (GBS), anaphylaxis, and death—were rare, at less than two of each per-million people vaccinated, according to their early-release report in Vaccine.

 

The authors examined all reports submitted to the Vaccine Adverse Event Reporting System (VAERS) for the H1N1 vaccine from October 2009 through January 2010. They compared the H1N1 reports with seasonal vaccine adverse event reports for the past five seasons, including 2009-10.

 

"The AE profile after 2009-H1N1 vaccine in VAERS was consistent with that of seasonal influenza vaccines," their report says. "The reporting rate was higher after 2009-H1N1 than seasonal influenza vaccines, which may, in part, be a reflection of stimulated reporting."

 

VAERS, administered by the FDA and CDC, accepts AE reports after immunization with all US-licensed vaccines. It is not designed to determine if AEs are caused by vaccines, but it detects signals of possible problems, which can then be tested using other data sources, the article notes.

 

Using data from the CDC's National 2009 H1N1 Flu Survey, the authors estimated that 82.4 million doses of H1N1 vaccines were administered in the 4-month study period. That included 64.6 million doses of inactivated vaccine and 17.5 million doses of live attenuated (intranasal) vaccine.

 

The group also estimated that 125.5 million doses of seasonal flu vaccines were administered from August 2009 through January 2010, including 117.6 million doses of inactivated vaccine and 7.9 million doses of live vaccine.

 

A total of 10,085 AE reports were submitted in connection with the H1N1 vaccine, of which 726 (7.2%) were classified as serious. For the seasonal vaccine, there were 6,469 reports, 540 (8.3%) of which were listed as serious.

 

The total rates of AEs within the four different age-groups examined were 2 to 3 times higher for the H1N1 vaccine than for the seasonal vaccine, signaling significant differences, the report says.

 

The rate of serious events reported for the pandemic vaccine was 8.8 per million doses, which was significantly higher than the 4.1 per million doses reported for the seasonal vaccine (P<.01). Serious events were defined as death, hospitalization, life-threatening illness, persistent or significant disability, or congenital anomaly.

 

In comparing reports for the pandemic vaccine with those for the past five seasonal vaccines, the researchers found few differences in the percentages of all AEs classified as serious.

 

Of 176 possible GBS reports, the authors verified 99 (56%). Ninety-three patients had GBS onset within the "biologically plausible window" of 42 days after vaccination. The GBS reporting rates were 0.42 per million vaccinees for those younger than 25 and 1.75 per million for those 25 and older, both of which are below the expected population background rates, based on a CDC analysis of published reports.

 

VAERS reports related to the H1N1 vaccine included 48 deaths. Cardiovascular conditions were listed as the cause of death in 22 cases, and 45 of the 48 victims had underlying medical conditions and risk factors for cardiovascular disease. There were no anaphylaxis deaths.

 

A review of the 48 deaths revealed no patterns suggesting that they were caused by the vaccine, the report says.

 

While the number of AE reports and the reporting rate were higher for the H1N1 vaccine than for the 2009-10 seasonal vaccine, the researchers write, "These findings, however, should be interpreted in light of the publicity around the 2009 H1N1 vaccine and efforts to increase reporting to VAERS. Heightened public awareness and stimulated reporting likely enhanced reporting to VAERS.

 

"Furthermore, although 2009-H1N1 was licensed similarly to seasonal influenza vaccines, it was likely perceived as a 'new' vaccine by the public and susceptible to the known tendency (i.e., the Weber effect) for adverse events to be reported more frequently following newly licensed products."

 

The report adds that many efforts were made to boost AE reports for the pandemic vaccine, including providing an information card to vaccinees that included VAERS reporting information. As a result, the VAERS Web site received three times as many visits in the 2009-10 season as in past seasons.

 

The authors also comment that the fairly consistent reporting of AEs for the H1N1 vaccine compared with the seasonal vaccine among all age-groups and for both serious and nonserious events "argues against an association between [the] vaccine and a particular adverse outcome."

 

They also note that VAERS was just one piece of a large pandemic vaccine safety monitoring effort, and several other systems, such as the Vaccine Safety Datalink, will be better equipped to assess potential links between the pandemic vaccine and adverse reactions.

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Guest Eileen Dannemann

CDC allegedly falsifies reports--ignoring up to 3,587 Miscarriages from H1N1 Vaccine

 

A shocking report from the National Coalition of Organized Women (NCOW) presented data from two different sources demonstrating that the 2009/10 H1N1 vaccines contributed to an estimated 1,588 miscarriages and stillbirths. A corrected estimate may be as high as 3,587 cases. NCOW also highlights the disturbing fact that the CDC failed to inform their vaccine providers of the incoming data of the reports of suspected H1N1 vaccine related fetal demise.

 

NCOW collected the data from pregnant women (age 17-45 years) that occurred after they were administered a 2009 A-H1N1 flu vaccine. The raw data is available on the website.

 

Using the Vaccine Adverse Event Reporting System (VAERS), including updates through July 11, 2010 as a second ascertainment source, capture-recapture statistical methods* were used to estimate the true number of miscarriages and stillbirths following A-H1N1 flu vaccination in the U.S. Typically, even so-called "complete" studies conducted by the CDC have been shown to miss from 10% to 90% of the actual cases because of under-reporting.

 

The statistical method employed is an expeditious and cost effective method of attempting to ascertain a complete count of all cases when two or more ascertainment sources (VAERS and NCOW survey) have failed to collect all the existing cases. Overall, this approach shows that approximately only 15% of the occurrences of a miscarriage or stillbirth were actually reported.

 

The corrected estimate for the total number of 2009-A-H1N1-flu-shot-associated miscarriages and stillbirths during the 2009/10-flu season is 1,588 (95% goodness-of-fit confidence interval, 946 to 3587). That is, the lower and upper range-probability of miscarriage and stillbirths due to the H1N1 vaccine was as low as 946 and as high as 3,587.

 

Eileen Dannemann, Director of NCOW, presented the findings for the second time to Dr. Marie McCormick, chair of the Vaccine Risk and Assessment Working Group, during the Advisory Commission on Childhood Vaccines (ACCV) meeting, Sept 3, 2010. Just prior to Ms. Dannemann’s presentation Dr. McCormick, had pronounced that there were absolutely no H1N1 vaccine-related adverse events in pregnant women in 2009/10, directly contradicting the evidence publicly available. “This baseless and fallacious assessment by the CDC assessment group” says, Dannemann, “has given the green light to the CDC's Advisory Committee on Immunization Practices (ACIP) to continue their recommendation to give the 2010/11 flu shot to all people, including pregnant women. This upcoming 2010/11 flu vaccine contains the same elements that are implicated in the killing of these fetuses, the H1N1 viral component and the neurotoxin mercury (Thimerosal). Additionally, it contains 2 other viral strains- a 3 in 1 shot for all people”.

 

The very next week at the Sept 14th National Vaccine Advisory Committee (NVAC) meeting Dr. McCormick, (despite having been informed on two previous occasions of the VAERS data) pronounced, once again, that there were no adverse events in pregnant women. At the conclusion of the NVAC meeting, during public comment, Dannemann submitted the data for the 3rd time and concluded with, “Why hasn’t Dr. McCormick looked in the VAERS data base?” “She looked where she knew she would not find”, a disquieting thought, Ms. Dannemann, said in retrospect.

 

Excerpts and adaptation from speech delivered by Eileen Dannemann, Director, National Coalition of Organized Women Friday, September 3, 2010 to the Advisory Commission on Childhood Vaccines (ACCV) meeting.

 

 

“Initially, at the beginning of the H1N1 pandemic consequence management drill there were allegedly 30 maternal deaths. It was these deaths that the CDC used as the basis to initiate a strenuous and aggressive campaign to vaccinate the pregnant population with the untested H1N1 vaccine. The CDC ascertained that there were eventually a total of 56 maternal deaths (assuming the fetuses died with them). Dr. Alicia Siston’s JAMA study (CDC) acknowledged that most of these deaths were ‘unconfirmed’ H1N1 virus caused deaths despite the fact that the CDC had tests that could have verified, for certain, that these were H1N1 related deaths.

 

Vaccine-related fetal demise reports from VAERS increased 2,440%--from 7 cases in 2007/8 to 178 in 2009/10. Seventy deaths reported from another source had 7 overlapping cases with VAERS, yielding 241 unique cases. Simplistically speaking, it would have been 85 to 192 times safer not to vaccinate from the perspective of the in-utero child.

 

Considering that the total of 56 maternal deaths in Dr. Alicia’s Siston’s study, allegedly due to the H1N1 virus itself, are unverified and in light of the overwhelming adverse events reported, we emphasize that inoculating pregnant women with another untested vaccine containing a combination of components found in the offending 2009 H1N1 vaccine is insupportable. Thus, it must be argued that the CDC was grossly negligent to fail to inform their vaccine providers of the incoming VAERS data, while providers blindly followed the CDC “standard of care” guidelines to vaccinate every pregnant woman in 2009/10. Furthermore, in the face of these findings and the purposeful withholding of these findings by CDC’s Dr. Marie McCormick and her vaccine risk assessment group, for the CDC’s Advisory Committee on Immunization Practices (ACIP) to recommend another iteration of the same vaccine to pregnant women in 2010/11 may be argued as more than gross negligence -but rather- an act of willful misconduct.

 

We strongly recommend that the CDC withdraws their continued recommendation to pregnant women, instead, strictly adhering to the FDA/manufacturers warning on the insert packages that the flu shot not be given to pregnant women unless clearly needed. As well, we suggest that the CDC advise all Ob/Gyns, vaccine providers and the public this year, of last season’s VAERS reports on H1N1 vaccine-related fetal deaths” despite the fact that it may be contrary to CDC’s vaccine uptake performance goals”.

 

Science Contact: Dr. Paul G. King, NCOW Sci. Advisor [phone: 973-997-1321, e-mail: drking@gti.net

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