The CDC is updating the MMR and MMRV Vaccine Information Sheets (VIS).
These are required by the National Childhood Vaccine Injury Act of 1986 (42 U.S.C. §§ 300aa-1 to 300aa-34) which states:
“The information in such materials shall be based on available data and information, shall be presented in understandable terms and shall include:
(1) a concise description of the benefits of the vaccine,
(2) a concise description of the risks associated with the vaccine,
(3) a statement of the availability of the National Vaccine Injury Compensation Program, and
(4) such other relevant information as may be determined by the Secretary
The public comment on the changes to the MMR and MMRV Vaccine Information Sheets can be made until December 19, 2016, by clicking here. https://www.regulations.gov/docket?D=CDC-2016-0094
TAKE ACTION TODAY:
Submit your public comment by midnight EDT, December 19, 2016, by clicking here. https://www.regulations.gov/docket?D=CDC-2016-0094. A Voice For Choice Advocacy recommends drafting comments in a word document and then cutting and pasting when submitting online as there is a limited amount to time to comment before the session times out. You can use the sections and comments below to support your comments.
The CDC has clear instructions for the comments to be taken into consideration so be sure to follow them:
– Identify you are referring to Docket No. CDC-2016-0094
– Be specific and reference particular sections.
– Provide supporting documents and data.
– Do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure. Our comments can make a difference. HHS/CDC state they will carefully consider and address all comments submitted and may revise the content of the rule as appropriate at the final rulemaking stage. HHS/CDC will publish a final rule after the comment period that reflects any content changes made as a result of comments received.
AVFCA Analysis and Comments on Changes to MMR and MMRV Vaccine Information Statements:
The VIS for MMR and MMRV are very similar and so our comments apply to both, unless stated otherwise. If you wish to see the specific changes made to the two VIS statements you can click here for the MMR VIS and here for the MMRV VIS. The most important suggestion AVFCA has is that a link to the full package insert be added to the VIS.
Overall – the statements are mostly the same, but there are some sentences that are not consistent across the two VIS, such as the disease descriptions in Section 1.
Specific Section comments:
Taken out: Before vaccines, these diseases were very common in the United States.
Replaced with: Vaccination programs have made these diseases much less common in the U.S. But if we stopped vaccinating, these diseases could return and cause a lot of people to become ill.
Comment: Take out the second sentence. This is fearmongering, hypothetical and speculative. Disease is increasing among the vaccinated populations currently.
The disease descriptions differ in the MMR vs MMRV VIS. For example, but not limited to:
Measles virus causes fever, cough, runny nose, and red, watery eyes, followed by rash
Measles can lead to ear infection, pneumonia, brain damage, and death.
Causes rash, cough, runny nose, eye irritation, fever.
Can lead to ear infection, pneumonia, brain damage, and death.
Comment: Make two VIS statements consistent in wording. The MMR looks to have been updated but the MMRV has not.
Taken out: “sterility” in disease description
Replaced with: “death”
Comment: Sterility is a more common side effect from the mumps disease than death so if death is included then sterility should be as well.
General Section 1 Comment: For all disease descriptions – including death for these in the US is not appropriate as death from measles, mumps rubella or varicella is (or was when they were more prevalent) extremely rare in the US. (Understood that globally that may be different, but this VIS should only refer to the US as that is where it will be used). It is misleading and fearmongering to say that these diseases lead to death, here in the US where this VIS will be used.
General Section 1 Comment: These should give the likelihood of getting each of these disease side effects in US today, so the consumer can do a risk/benefit evaluation.
Comment: The Proquad (MMRV) package insert reads:
Administration of ProQuad (dose 1) to children 12 to 23 months old who have not been previously vaccinated against measles, mumps, rubella, or varicella, nor had a history of the wild-type infections, is associated with higher rates of fever and febrile seizures at 5 to 12 days after vaccination when compared to children vaccinated with M-M-R® II and VARIVAX® administered separately. (5.1, 6.1, 6.3)
This is mentioned in Section 4, but should be mentioned here when the options are given. Consumers should be made aware that there is a higher risk of severe side effects using the MMRV vs the MMR and V separately.
Comment: Both VIS updated to read “There are no known risks to getting MMRV/MMR vaccine at the same time as other vaccines.”
However the ProQuad (MMRV) package insert reads:
Tuberculin testing should be administered anytime before, simultaneously with, or at least 4 to 6 weeks after ProQuad. (7.4)
ProQuad may be administered concomitantly with Haemophilus influenzae type b conjugate vaccine and/or hepatitis B vaccine at separate injection sites. (7.5)
ProQuad may be administered concomitantly with pneumococcal 7-valent conjugate vaccine and/or hepatitis A vaccine (inactivated) at separate injection sites. (7.5)
The MMRV vaccine has not been advised with vaccines other than these and although the statement is accurate it is omitting the fact that only a few vaccines may be administered at the same time.
And the MMRII package insert reads:
Routine administration of DTP (diphtheria, tetanus, pertussis) and/or OPV (oral poliovirus vaccine) concurrently with measles, mumps and rubella vaccines is not recommended because there are limited data relating to the simultaneous administration of these antigens.
The MMR vaccine has not been advised with these two vaccines and the statement should be updated to reflect this.
Comment: Both MMRV and MMR VIS state that a second dose can be administered 3 months or 28 days after the first dose if necessary.
Neither Package insert nor the CDC pink book states that the second dose can be given in 28days or 3 months.
Comment: The MMRII package insert reads:
Following vaccination, antibodies associated with protection can be measured by neutralization assays, HI, or ELISA (enzyme linked immunosorbent assay) tests.
Titer testing should be mentioned on the VIS so that consumers are aware that a titer test could be used to determine if a second dose is necessary.
Taken out: Anyone who has ever had a life-threatening allergic reaction to the antibiotic neomycin, or any other component of MMR vaccine, should not get the vaccine. Tell your doctor if you have any severe allergies.
Comment: Neomycin is still used in the production of MMRII and Proquad. This reference should be added back in. A link to the excipient list should be included here or somewhere on the sheet, so that customers know where to look for ingredients. https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/b/excipient-table-2.pdf
Inserted: Getting MMRV/MMR vaccine is much safer than getting measles, mumps, rubella, or chickenpox disease.
Comment: Need reference to research that shows this as if you look at VAERS or the compensation given by VCIP it is contrary to this. Need to give the relative risk of getting each disease in the US and death vs vaccine side effects and death in the US if you claim this.
Removed: Likelihood of side effects happening, e.g. (about 1 child out of 5).
Comment: Add these numbers back in and also add them for the likelihood in Section 1 for the US/
General Section 4 Comment: Death is not included in the side effects anywhere. It is as common as the death from the actual disease in the US. If you have death mentioned in Section 1 then it should be mentioned here, or taken out in both places. Otherwise it is fearmongering and unbalanced
Comment: The side effects mentioned in this section, e.g hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness, have not been mentioned in Section 4 as side effects. Should be consistent.
Inserted: Ask your healthcare provider. He or she can give you the vaccine package insert or suggest other sources of information.
Comment: The vaccine package insert link should be added to sheet so that customers have it handy if they wish to read it. http://www.immunize.org/fda/#var[:]