Published Thursday, April 23, 2020 

By the A.M. Costa Rica staff and wire services

The BioNTech and Pfizer Inc. companies have announced on Wednesday that the German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase 1/2 clinical trial for BioNTech’s BNT162 vaccine program to prevent covid-19 infection.

These companies are jointly developing BNT162. The trial is the first clinical trial of a covid-19 vaccine candidate to start in Germany and is part of a global development program.

Both pharmaceutical firms will also conduct trials for BNT162 in the United States upon regulatory approval, which is expected shortly.

The four vaccine candidates are the first from BioNTech’s covid-19-focused project “Lightspeed,” each representing different mRNA formats and target antigens.

Two of the four vaccine candidates include a nucleoside modified mRNA (modRNA), one includes uridine containing mRNA (uRNA), and the fourth vaccine candidate utilizes self-amplifying mRNA (saRNA).

Each mRNA format is combined with a lipid nanoparticle (LNP) formulation. The larger spike sequence is included in two of the vaccine candidates, and the smaller optimized receptor-binding domain (RBD) from the spike protein is included in the other two candidates.

The RBD-based candidates contain the piece of the spike that is thought to be most important for eliciting antibodies that can inactivate the virus.

The dose-escalation portion of the Phase 1/2 trial will include approximately 200 healthy subjects between the ages of 18 to 55 and will target a dose range of 1 µg to 100 µg aiming to determine the optimal dose for further studies as well as evaluate the safety and immunogenicity of the vaccine.

The study will also evaluate the effects of repeated immunization for three of the four vaccine candidates which utilize uRNA or modRNA. Subjects with a higher risk for a severe covid-19 infection will be included in the second part of the study.

“We are pleased to have completed pre-clinical studies in Germany and will soon initiate this first-in-human trial ahead of our expectations," said Ugur Sahin, co-founder and CEO of BioNTech." The speed with which we were able to move from the start of the program to trial initiation speaks to the high level of engagement from everyone involved.”

“Pfizer and BioNTech’s partnership has mobilized our collective resources with extraordinary speed in the face of this worldwide challenge,” said Albert Bourla, Chairman and CEO of Pfizer. “Now that the work in Germany can commence, we are looking forward to and actively preparing for the potential start of this unique and robust clinical study program in the United States in the near future.”

During the clinical development stage, BioNTech will provide its partners clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe.

BioNTech is also collaborating with Fosun Pharma to develop BNT162 in China, where the companies expect to conduct trials.


In the country, the Ministry of Health confirmed on Wednesday an increase of 12 new patients infected with the virus, increasing the total to 681 cases.

Authorities provided the following statistics:

- The patients' ages range from 1 to 87 with an average age of 37. Of those, 34 are children under the age of 13, 613 are between 18 and 70 years old, and 34 are elder patients over the age of 70.

- 11 are being treated in public hospitals, where 8 of them have been reported in intensive care with delicate health conditions.

- Of those infected, 326 are women (47%) and 355 are men (53%).

-133 patients are employees of Social Security.

- 65 foreigners infected.

- 180 coronavirus patients have fully recovered, of these 92 women and 88 men.

- 7,784 people have been ruled out since the virus was first reported in the country in March.

- Six deaths reported from patients infected with covid-19.

The most recent death was reported on April 20. A 54-year-old Cuban man, diagnosed with the coronavirus on March 6 was identified as a superspreader of covid-19. A superspreader is an individual who is more likely to infect others, compared to a typical infected person. According to the authorities, he was linked to 81 people infected with covid-19.

On April 19, a 69-year-old Costa Rican who was diagnosed with the coronavirus on March 25 died.

On April 15, an 84-year-old Costa Rican man who had tested positive for covid-19 on April 1 was reported dead.

On April 8, a 45-year-old Costa Rican died after being hospitalized for 10 days in the intensive care of the San Juan de Dios Hospital.

The first two patients died in March. They were hospitalized in intensive care at San Rafael Hospital in Alajuela Province, both 87-years-old.

The UNED University provides a daily updated number of patients infected in each district throughout the country at its  Covid-19 Map.

As of Wednesday night, 2,623,415 people have been confirmed infected worldwide. The pandemic has killed 183,027 patients and 709,541 patients made a full recovery, according to recent statistics reported by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University.

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