Expert review of vaccines
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Expert review of vaccines · Aug 2020
Safety profile of Infanrix hexa - 17 years of GSK's passive post-marketing surveillance.
This paper reports 17 years of passive safety surveillance of routine use of the pediatric hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b-conjugate vaccine (DTPa-HBV-IPV/Hib, Infanrix hexa, GSK). ⋯ What is the context? The cornerstone of childhood vaccination in many countries worldwide is a vaccine that protects against several diseases: diphtheria, tetanus, whooping cough, hepatitis B, polio and Haemophilus influenzae type b infections (such as meningitis). One of these vaccines (the longest on the market) is called Infanrix hexa; it has been available for infants and toddlers since 2000. After a vaccine is included in a country's routine vaccination program, its safety is constantly checked; this is done in clinical trials and through spontaneous reporting of adverse events after vaccination. It is important to share up-to-date information on the safety of vaccines, particularly since concerns about vaccine safety in parents may lead to lower vaccination rates an disease outbreaks. Here we summarize 17 years of safety data for the Infanrix hexa vaccine. What is new? We analyzed spontaneously reported adverse events after Infanrix hexa vaccinations between 2000 and 2017 The most commonly reported adverse events were fever, crying and injection site redness and swelling An in-depth review of extensive limb swelling after Infanrix hexa vaccination revealed no safety concerns. There was no increased risk of sudden death after Infanrix hexa vaccination, consistent with what was shown in several other studies. As shown previously, seizures were more common when Infanrix hexa was given together with the pneumococcal conjugate vaccine, Prevnar 13, than when it was given alone. What is the take-home message? The large amount of safety data gathered from clinical trials and from spontaneous adverse event reporting during 17 years of routine vaccination with Infanrix hexa supports its continued use in young children.
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Expert review of vaccines · Aug 2020
Vaccination against SARS-CoV-2 and disease enhancement - knowns and unknowns.
The world is currently fighting a COVID-19 pandemic, perhaps the most disruptive infectious disease outbreak since the 1918 Spanish influenza. Governments have taken drastic measures to curb the spread of SARS-CoV-2, and the development of safe and efficacious vaccine candidates is being accelerated. The possibility of vaccine-mediated disease enhancement with coronavirus vaccines has been flagged as a potential safety concern, and, despite the urgent need, should be thoroughly assessed as vaccines against SARS-CoV-2 are being tested. ⋯ We compile and propose avenues to investigate the risk of vaccine-mediated disease enhancement both during pre-clinical and early clinical development. While the pressing need for a vaccine against COVID-19 (and future epidemic coronaviruses) cannot be ignored, we advocate to keep safety at the center of the debate. Protecting individuals with effective and safe vaccines should be a priority, even during extraordinary times like the COVID-19 pandemic.