NEW YORK & MAINZ — Aprubado na ng Advisory Committee on Immunization Practices (ACIP) ng US Centers for Disease Control and Prevention (CDC) ang paggamit ng COVID-19 vaccine ng Pfizer at BioNTech sa mga edad 16-anyos pataas.
“Today’s ACIP recommendation marks a momentous step in this historic journey and the beginning of another, as we work jointly with the U.S. government, other vaccine companies and our many partners to execute the largest mass vaccination program in our nation’s history. Collectively, we aim to vaccinate hundreds of millions of Americans by the end of 2021,” ani Albert Bourla, chief executive officer ng Pfizer.
Magugunitang ginawaran kamakailan ng US Food and Drug Administration (FDA) ng Emergency Use Authorization (EUA) ang bakuna ng naturang mga kompanya.
Kaakibat nito ang rekomendasyon ng ACIP na mga health care workers, at mga residente ng nursing homes at iba pang long-term care facilities ang maging prayoridad ng inisyal na vaccine roll out.
Ayon sa ACIP, ginamit nilang batayan sa rekomendasyon ang scientific evidences na naka-publish sa The New England Journal of Medicine.
Pinagtibay kasi ng peer-reviewed journal ang resulta ng Pfizer-BioNTech Phase III clinical trial na higit 90% effective ang kanilang bakuna.
“We started our project to develop a potential COVID-19 vaccine in January because we felt we had a duty to leverage our mRNA technologies and fast vaccine development competences to help address the pandemic,” ayon kay BioNTech co-founder at CEO Dr. Ugur Sahin.
Naghahanda na ngayon ang mga kompanya na para sa aplikasyon ng Biologics License.
Ipapadala sa US Department of Defense ang unang supply ng bakuna na manggagaling sa Kalamazoo, Michigan site ng Pfizer.
Ang rekomendasyon naman ng ACIP ay agad daw ibababa sa direktor ng CDC at Department of Health and Human Services.
SAFETY INFORMATION
Kasabay ng approval ng advisory council sa paggamit ng Pfizer vaccine, ipinaalala ng mga kompanya ang ilang mahalagang gabay sa mga tatanggap ng bakuna.
Ayon sa Pfizer, asahan ang ilang side effect dahil nakaramdam nito ang mga sumali sa clinical trial. Kabilang sa pinababantayang side effect ay ang:
- pain at the injection site (84.1%),
- fatigue (62.9%)
- headache (55.1%)
- muscle pain (38.3%)
- chills (31.9%)
- joint pain (23.6%)
- fever (14.2%)
- injection site swelling (10.5%)
- injection site redness (9.5%)
- nausea (1.1%)
- malaise (0.5%)
- lymphadenopathy (0.3%)
Kaya naman pinaiiwas ng kompanya na isali ang mga may history na ng allergic reaction dahil sa posibilidad ng mas malalang reaksyon.
“Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer BioNTech COVID-19 Vaccine.”
“Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer BioNTech COVID-19 Vaccine.”
Dagdag pa ng kompanya, wala pang kumpletong datos ukol sa epekto ng bakuna sa mga buntis.
“Data are not available to assess the effects of Pfizer BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion.”
Binigyang diin ng kompanya na walang garantiya na mabibigyan ng kanilang bakuna ng proteksyona ng lahat ng matuturukan nito.
