Antequera Hospital Prepares Study Startup for COVID-19 Vaccine Trial Targeting Children (6mo-12 yrs.) & Pregnant Women

Antequera Hospital Prepares Study Startup for COVID-19 Vaccine Trial Targeting Children (6mo-12 yrs.) & Pregnant Women

The interest in the mRNA-based vaccine BNT162b2 developed by Pfizer and Germany’s BioNTech continues to rise in Europe with mounting concerns on the European continent with COVID-19 vaccine products produced by AstraZeneca and Johnson and Johnson. A new clinical trial testing the BNT162b2 vaccine on children and pregnant women commences in May, and the trial sites selected now become public. In Spain, TrialSite learned that five trial site locations were selected, one of them the Antequera Hospital located in Málaga, part of Andalusia. According to reports, the clinical trial team will administer two doses of the mRNA-based vaccines over a three week period and includes volunteers ranging from children six months to 12 years old and pregnant women. The study will be conducted by specialists from pharmacy, gynecology and pediatrics division. Pfizer shares more about this study covering “additional populations.” 

Pfizer already commenced comparable studies in the United States with a study concentrating on pregnant women (NCT04754594) and multiple studies looking at youth (NCT04816643). 

COVID-19 in Spain

Antequera Hospital is situated in the southern province of Málaga in the broader southern region known as Andalusia. With about 8.3 million people in this southmost part of Spain, this region and Spain as a whole seemingly has stabilized as compared to other parts of Europe currently experiencing a bad wave of infections. But that could be changing.

While a more recent spike occurred in mid-February, where in one day over 13,000 people were reported infected, most recently the seven day daily average number of cases is 7,541. With about 47 million people, Spain has a total number of 3.4 million cases and 76,981 deaths. The country has been hit hard by this coronavirus as, for example, its population is considerably smaller than that of Germany yet Spain has more recorded COVID-19 cases.  But for whatever reason, Spain has avoided this most recent wave impacting Germany and other European countries.

However, this could be about to change as reports from press tell of growing numbers of cases and the possibility that the problematic wave to the north comes south. As the nation’s Health Ministry reports, 10,474 new infections just last Wednesday, one of Europe’s hardest hit countries truly lives on the edge. A recent article in Al Jazeera reports that COVID-19 infection rates are on the rise in all but a handful of regions here.

More Study Details

Involving specialist physicians from pharmacy, gynecology and pediatric services in what’s known as the Northern Area of Málaga, the study is led by principal investigator Mariano Miranda Valdivieso and study coordinator María del Mar Pérez Hidalgo. This study team was selected in part due to their expertise in studies with these demographics—they are part of the Matisse Study, for example. The Matisse maternal vaccine clinical study investigates if giving pregnant women an investigational vaccine for respiratory syncytial virus (RSV) is safe and helps protect the babies from RSV after they are born. The recent study was announced by Juan Manuel Moreno, the president of the Junta de Andalucia, in a personal Tweet, declaring “The rate of vaccination in Andalusia isn’t stopping: we are the first region to exceed two million vaccinations.”

‘Absolutely Safe’

Some within Spain have questioned the safety of the various vaccines, particularly given the recent pauses in trials involving AstraZeneca in Europe—Denmark just announced, for example, they would permanently opt out of the AstraZeneca roll out plan for good as reported by the BBC. By April 6, vaccination rates in Spain varied by region ranging anywhere from 20% up to nearly 27% of the total population.

In responding to calls from some corners of the country questioning vaccine safety, the Prime Minister Pedro Sanchez went on the record that the vaccines are absolutely safe, declaring, “The risk-benefit analysis is without a doubt absolutely tipped in favor of benefit, of saving lives.” The BNT162b2 vaccine is approved for use in Europe by the European Medicines Agency.

Lead Research/Investigator

Mariano Miranda Valdivieso, Pediatric Management Unit, Antequera Hospital

Responses

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  1. Any parent who enrolls a baby in one of these trials should be arrested for child abuse.

    Any pregnant woman who joins one is out of her mind.

    There, is that subtle enough? Children do NOT need the vaccine.