Biontech y Pfizer pedirán autorización de su vacuna en EEUU / ‘COVID-19 vaccine candidate over 90% effective’

BERLÍN.- El consorcio alemán Biontech y el estadounidense Pfizer informaron este lunes que la próxima semana solicitarán a las autoridades de EEUU la autorización para el uso generalizado de la vacuna que han desarrollado de forma conjunta.

Según Biontech, los estudios clínicos realizados muestran que las personas que reciben la vacuna tienen una protección contra el coronavirus un 90 por ciento mayor que los no vacunados.

La vacuna BNT162b2 se empezó a desarrollar en enero en un proyecto bautizado como «Velocidad de la luz».

La fase 3 de los ensayos se inició en julio y hasta ahora 43.500 personas han recibido al menos una de las dos inyecciones que deben aplicarse dentro del plazo de dos semanas.

La protección se obtiene a partir de la segunda inyección.

Biotech y Pfizer calculan que este año podrán producir 50 millones de dosis, mientras que para 2021 estiman contar con 1.300 millones de dosis.

‘COVID-19 vaccine candidate over 90% effective’

Protection achieved 28 days after initiation of vaccination, say US drugmaker Pfizer, German biotech firm BioNTech

US drugmaker Pfizer and German biotech firm BioNTech announced Monday their COVID-19 vaccine candidate is more than 90% effective against the novel coronavirus.

The pharmaceutical firms said in a statement their vaccine candidate “has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection.”

The study had 43,538 participants, with 42% from diverse backgrounds, and analyzed 94 confirmed COVID-19 infections, with no serious safety concerns observed.

The companies said they will submit the vaccine candidate to the US Food and Drug Administration for emergency use authorization, expected to occur in the third week of this month.

“The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose,” the statement noted.

“This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule,” it added.

There are currently more than 170 vaccine candidates for COVID-19 around the world tracked by the World Health Organization, while none has been approved yet for general use.

Globally, there are nearly 50.5 million infections and more than 1.2 million deaths from COVID-19, according to Johns Hopkins University data.