US approves Pfizer's coronavirus vaccine for emergency use

First Published Dec 12, 2020, 8:14 AM IST

The US Food and Drug Administration has authorised Pfizer's coronavirus vaccine for emergency use.

<p>The US Food and Drug Administration has authorised Pfizer's coronavirus vaccine for emergency use. The FDA nod makes US the sixth nation to authorise the vaccine.<br />
 </p>

<p>US officials say that about 2.9 million doses will be sent in the first week, with priority being given health care workers and nursing home residents.<br />
 </p>

<p>The US FDA approval came a day after Vaccines and Related Biological Products Advisory Committee gave a go ahead to the COVID-19 mRNA vaccine (BNT162b2).<br />
 </p>

The US Food and Drug Administration has authorised Pfizer's coronavirus vaccine for emergency use. The FDA nod makes US the sixth nation to authorise the vaccine.

US officials say that about 2.9 million doses will be sent in the first week, with priority being given health care workers and nursing home residents.

The US FDA approval came a day after Vaccines and Related Biological Products Advisory Committee gave a go ahead to the COVID-19 mRNA vaccine (BNT162b2).

<p>The recommendation was based on scientific evidence shared, including data from a pivotal Phase 3 clinical study announced last month. <br />
 </p>

<p>The Phase 3 data demonstrated a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. <br />
 </p>

<p>Efficacy was consistent across age, gender, race and ethnicity demographics. All trial participants will continue to be monitored for an additional two years after their second dose to assess long-term protection and safety.</p>

The recommendation was based on scientific evidence shared, including data from a pivotal Phase 3 clinical study announced last month.

The Phase 3 data demonstrated a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose.

Efficacy was consistent across age, gender, race and ethnicity demographics. All trial participants will continue to be monitored for an additional two years after their second dose to assess long-term protection and safety.

<p><strong>mRNA vaccines are considered safe</strong><br />
 </p>

<p>The mRNA vaccine is considered safe as is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms. <br />
 </p>

<p>They are expected to be highly efficacious because of their inherent capability of being translatable into the protein structure inside the cell cytoplasm. <br />
 </p>

<p>Additionally, mRNA vaccines are fully synthetic and do not require a host for growth, e.g., eggs or bacteria. <br />
 </p>

<p>Therefore, they can be quickly manufactured in an inexpensive manner under cGMP conditions to ensure their "availability" and "accessibility" for mass vaccination on a sustainable basis.</p>

mRNA vaccines are considered safe

The mRNA vaccine is considered safe as is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms.

They are expected to be highly efficacious because of their inherent capability of being translatable into the protein structure inside the cell cytoplasm.

Additionally, mRNA vaccines are fully synthetic and do not require a host for growth, e.g., eggs or bacteria.

Therefore, they can be quickly manufactured in an inexpensive manner under cGMP conditions to ensure their "availability" and "accessibility" for mass vaccination on a sustainable basis.

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