Two essential FDA authorized changes to the caution label of Merck Pharmaceutical’s shingles vaccine, Zostavax, have been made considering that the controversial drug was presented in 2006. The first was in 2014, when, in addition to possibly triggering chickenpox, another side effect was included: shingles! The vaccine that had been– and continues to be– strongly marketed to avoid elders from contracting this unbearable condition was found to really cause shingles in some people.
In February 2016, the FDA authorized a label change to alert those who recommend the Zostavax vaccine of another possible side effect: “Eye Disorders: necrotizing retinitis.”
Vision Damage connected to Shingles Vaccine
This condition, along with keratitis, causes inflammation and scarring of the eye tissue and can lead to irreversible vision loss if not treated quickly. It was reported, 20 people (children and adults) developed keratitis within a month of getting a chickenpox or shingles vaccine. Keratitis symptoms for adults developed within 24 days of vaccination, while symptoms in children began within 14 days of vaccination.
Researchers concluded there is a possible relationship in between the vaccine and the eye inflammation, though the study wasn’t developed to prove the vaccine really caused the condition.
While researchers have no idea why the shingles shot might cause keratitis, the condition has actually been linked to autoimmune conditions. The connection in between vaccines and autoimmune disease has been commonly acknowledged, most recently by medical scientists worldwide in a compilation of studies released in 2015 in the medical book, Vaccines & Autoimmunity.
Insignificant Effectiveness of Zostavax
Inning accordance with the authors of a Health Sciences Institute (HSI) article in January, 2016, “UCLA researchers found that just one in 175 people who get the vaccine will have the ability to dodge a shingles flare-up.” While Merck declares Zostavax is 50% reliable, in the placebo group, 3.3 percent of the research study participants established shingles, compared with 1.6 percent in the vaccine group. So, while that is a 50% difference, the genuine, absolute risk reduction is simply 1.7 percentage points.
Zostavax Side Effects
Inning accordance with its current caution label, Zostovax’s most typical side effects are “headache, inflammation, pain, itching, swelling, hard lump, heat, or bruising where the shot was offered.” Nevertheless, more serious “side effects” include:
- allergic reactions, which may be serious and might include difficulty in breathing or swallowing
- hives at the injection site
- joint pain
- muscle pain
- rash at the injection site
- swollen glands near the injection site (that may last a few days to a few weeks).
Nonetheless, in spite of its doubtful efficiency at avoiding shingles (and the fact that it can cause shingles!) and the serious side effects it can produce, online websites funded by the pharmaceutical industry and community drug stores continue to ominously encourage elders to get the shingles vaccines– at a cost of $150-$ 300 per injection. Zostavax is plainly reliable at something– and … about the profits it’s generating for its maker, promoters and distributors.
The most frequent unfavorable responses, reported in ≥ 1% of topics immunized with Zostavax, were headache and injection-site responses.
Because medical trials are conducted under widely varying conditions, rates of unfavorable responses observed in the medical trials of a vaccine can not be straight compared to rates in the medical trials of another vaccine and may not show the rates observed in practice.
Zostavax Efficacy and Safety Trial (ZEST) in Subjects 50 to 59 Years of Age
In the ZEST study, topics received a single dose of either Zostavax (N= 11,184) or placebo (N= 11,212). The racial distribution throughout both vaccination groups was comparable: White (94.4%); Black (4.2%); Hispanic (3.3%) and Other (1.4%) in both vaccination groups.
The gender distribution was 38% male and 62% female in both vaccination groups. The age distribution of topics enrolled, 50 to 59 years, was comparable in both vaccination groups. All topics got a vaccination report card (VRC) to record unfavorable occasions taking place from Days 1 to 42 postvaccination.
In the ZEST research study, serious unfavorable events occurred at a comparable rate in topics vaccinated with Zostavax (0.6%) or placebo (0.5%) from Days 1 to 42 postvaccination.
In the ZEST research study, all subjects were kept track of for unfavorable reactions. An anaphylactic response was reported for one subject immunized with Zostavax.
The majority of Common Adverse Reactions and Experiences in the ZEST Study
The overall incidence of vaccine-related injection-site unfavorable reactions within 5 days post-vaccination was greater for topics vaccinated with Zostavax as compared to subjects who got placebo (63.6% for Zostavax and 14.0% for placebo).
Systemic negative reactions and experiences reported during Days 1-42 at an occurrence of ≥ 1% in either vaccination group were headache (Zostavax 9.4%, placebo 8.2%) and pain in the extremity (Zostavax 1.3%, placebo 0.8%), respectively.
The total incidence of systemic unfavorable experiences reported during Days 1-42 was greater for Zostavax (35.4%) than for placebo (33.5%).
Shingles Prevention Study (SPS) in Subjects 60 Years of Age and Older
In the SPS, the largest clinical trial of ZOSTAVAX, topics got a single dosage of either Zostavax (n= 19,270) or placebo (n= 19,276). The racial distribution throughout both vaccination groups was similar: White (95%); Black (2.0%); Hispanic (1.0%) and Other (1.0%) in both vaccination groups. The gender circulation was 59% male and 41% woman in both vaccination groups. The age distribution of topics enrolled, 59-99 years, was similar in both vaccination groups.
The Adverse Event Monitoring Substudy of the SPS, designed to provide in-depth information on the safety profile of the zoster vaccine (n= 3,345 received Zostavax and n= 3,271 got placebo) used vaccination report cards (VRC) to record negative events taking place from Days 0 to 42 postvaccination (97% of topics completed VRC in both vaccination groups). In addition, month-to-month surveillance for hospitalization was carried out through the end of the research study, 2 to 5 years postvaccination.
The rest of topics in the SPS (n= 15,925 got Zostavax and n= 16,005 received placebo) were actively followed for safety results through Day 42 postvaccination and passively followed for safety after Day 42.
Serious Adverse Events Occurring 0-42 Days Postvaccination
In the general SPS study population, serious negative events happened at a similar rate (1.4%) in topics immunized with Zostavax or placebo.
In the AE Monitoring Substudy, the rate of SAEs was increased in the group of topics who got ZOSTAVAX as compared with the group of subjects who got placebo.
Among reported serious unfavorable occasions in the SPS (Days 0 to 42 postvaccination), serious cardiovascular occasions took place more regularly in topics who received Zostavax (20 [0.6%] than in topics who received placebo (12 [0.4%] in the AE Monitoring Substudy. The frequencies of serious cardiovascular occasions were comparable in subjects who received Zostavax (81 [0.4%] and in topics who got placebo (72 [0.4%] in the entire research study accomplice (Days 0 to 42 postvaccination).
Serious Adverse Events Occurring Over the Entire Course of the Study
Rates of hospitalization were comparable amongst topics who received Zostavax and topics who received placebo in the AE Monitoring Substudy, throughout the whole research study.
Fifty-one individuals (1.5%) getting Zostavax were reported to have heart disease (CHF) or pulmonary edema compared with 39 individuals (1.2%) receiving placebo in the AE Monitoring Substudy; 58 people (0.3%) receiving Zostavax were reported to have congestive heart failure (CHF) or lung edema compared to 45 (0.2%) people getting placebo in the total research study.
In the SPS, all topics were kept an eye on for vaccine-related SAEs. Investigator-determined, vaccine-related serious unfavorable experiences were reported for 2 topics vaccinated with Zostavax (asthma exacerbation and polymyalgia rheumatica) and 3 subjects who got placebo (Goodpasture’s syndrome, anaphylactic reaction, and polymyalgia rheumatica).
The occurrence of death was comparable in the groups receiving Zostavax or placebo during the Days 0-42 postvaccination period; 14 deaths took place in the group of topics who got Zostavax and 16 deaths happened in the group of subjects who got placebo. The most common reported cause of death was heart disease (10 in the group of subjects who received Zostavax, 8 in the group of topics who received placebo).
The general incidence of death taking place at any time during the research study was comparable in between vaccination groups: 793 deaths (4.1%) happened in topics who received ZOSTAVAX and 795 deaths (4.1%) in subjects who received placebo.
A lot of Common Adverse Reactions and Experiences in the AE Monitoring Substudy of the SPS
Injection-site unfavorable responses reported at an occurrence ≥ 1%. The majority of these negative responses were reported as mild in strength. The general incidence of vaccine-related injection-site adverse responses was significantly higher for topics vaccinated with Zostavax versus topics who got placebo (48% for Zostavax and 17% for placebo).
Headache was the only systemic unfavorable reaction reported on the vaccine progress report between Days 0-42 by ≥ 1% of topics in the AE Monitoring Substudy in either vaccination group (Zostavax 1.4%, placebo 0.8%).
The numbers of topics with elevated temperature (≥ 38.3 ° C [≥ 101.0 ° F] within 42 days postvaccination were similar in the Zostavax and the placebo vaccination groups [27 (0.8%) vs. 27 (0.9%), respectively]
The following adverse experiences in the AE Monitoring Substudy of the SPS (Days 0 to 42 postvaccination) were reported at an occurrence ≥ 1% and greater in topics who got Zostavax than in subjects who got placebo, respectively: respiratory infection (65 [1.9%] vs. 55 [1.7%], fever (59 [1.8%] vs. 53 [1.6%], flu syndrome (57 [1.7%] vs. 52 [1.6%], diarrhea (51 [1.5%] vs. 41 [1.3%], rhinitis (46 [1.4%] vs. 36 [1.1%], skin disorder (35 [1.1%] vs. 31 [1.0%], respiratory condition (35 [1.1%] vs. 27 [0.8%], asthenia (32 [1.0%] vs. 14 [0.4%].
VZV (varicella-zoster virus) Rashes Following Vaccination
Within the 42-day postvaccination reporting period in the ZEST, noninjection-site zoster-like rashes were reported by 34 topics (19 for Zostavax and 15 for placebo). Of 24 specimens that were sufficient for Polymerase Chain Reaction (PCR) screening, wild-type VZV was found in 10 (3 for Zostavax, 7 for placebo) of these specimens.
The Oka/Merck strain of VZV was not found from any of these specimens. Of reported varicella-like rashes (n= 124, 69 for Zostavax and 55 for placebo), 23 had specimens that were offered and sufficient for PCR screening. VZV was detected in among these specimens in the ZOSTAVAX group; however, the virus strain (wild-type or Oka/Merck strain) could not be identified.
Within the 42-day postvaccination reporting period in the SPS, noninjection-site zoster-like rashes were reported by 53 topics (17 for Zostavax and 36 for placebo). Of 41 specimens that were appropriate for Polymerase Chain Reaction (PCR) screening, wild-type VZV was spotted in 25 (5 for Zostavax, 20 for placebo) of these specimens. The Oka/Merck strain of VZV was not detected from any of these specimens.
Of reported varicella-like rashes (n= 59), 10 had specimens that were readily available and appropriate for PCR testing. VZV was not discovered in any of these specimens.
In scientific trials in support of the preliminary licensure of the frozen formulation of Zostavax, the reported rates of noninjection-site zoster-like and varicella-like rashes within 42 days postvaccination were also low in both zoster vaccine and placebo receivers. Of 17 reported varicella-like rashes and non-injection site zoster-like rashes, 10 specimens were readily available and adequate for PCR testing, and 2 topics had varicella (beginning Day 8 and 17) verified to be Oka/Merck strain.
The following additional adverse responses have been recognized during postmarketing use of Zostavax. Because these responses are reported willingly from a population of unpredictable size, it is generally not possible to reliably approximate their frequency or establish a causal relationship to the vaccine:
- gastrointestinal disorders: nausea
- infections and infestations: herpes zoster (vaccine strain)
- skin and subcutaneous tissue disorders: rash
- musculoskeletal and connective tissue disorders: arthralgia; myalgia
- general disorders and administration site conditions: injection-site rash; pyrexia; injection-site urticaria; short-term injection-site lymphadenopathy
- body immune system conditions: hypersensitivity reactions including anaphylactic reactions.
Good luck! Have a nice weekend!