CANDIDATES of the Pfizer-BioNTech Covid-19 vaccine will begin to experience partial protection as early as 12 days after the first dose, Pfizer told The Malaysian Insight.

The vaccine’s efficacy has also been observed as generally consistent across subgroups defined by age, gender, race, ethnicity, baseline body mass index (BMI), or presence of other underlying comorbidities, the drug maker said.

Findings from the vaccine’s clinical trials have been submitted to regulatory agencies across the globe, including the US Food and Drug Administration and the European Medicines Agency, for inoculation authorisation.

Pfizer developed the Covid-19 vaccine, also called BNT162b2, with Germany’s BioNTech and it has demonstrated 95% efficacy in preventing the coronavirus in those without prior infection, the US pharmaceutical corporation said.

“Data from 43,448 participants, half of whom received BNT162b2 and half of whom received placebo, showed the vaccine was well tolerated and demonstrated 95% efficacy in preventing Covid-19 in those without prior infection, seven days or more after the second dose,” Pfizer (Malaysia) Sdn Bhd said in response to queries from The Malaysian Insight.

In Malaysia, Pfizer said it has submitted the vaccine to the National Pharmaceutical Regulatory Division (NPRA) for approval.

In addition to the submission for Emergency Use Authorisation (EUA) on November 30, the company has also submitted additional documents required by the local regulator on December 14.

It added that it will work towards fulfilling its agreement with the Malaysian government to roll out supplies of the vaccine in the first quarter of next year.

The supply of 12.8 million doses will be sufficient for the inoculation of 6.4 million people or 20% of the population.

Health front-liners and high-risk groups will be first in line to receive the jab.

The Health Ministry signed an early recovery agreement on November 24 with Pfizer to procure the vaccine.

It was also the first Covid-19 vaccine to be approved by the US FDA for emergency use and it is currently being administered to the public in the country.

Apart from the US, the United Kingdom has also started administering the vaccine to the public under emergency approval.

As to problems so far, there have been reports of vaccine candidates suffering from allergic reactions after receiving their shots, prompting investigations by the US FDA.

The American regulator will also work with Pfizer to update its fact sheets and prescribe information to reflect the evolving findings, the Washington Post reported.

The US FDA said that the vaccine is safe for people with most allergies.

However, it should be avoided by those who have previously experienced severe allergic reactions to vaccines or ingredients in this particular vaccine.

Meanwhile, Britain’s medical regulator said those with a history of anaphylaxis, or severe allergic reactions to a medicine or food, should not get the Pfizer-BioNTech Covid-19 vaccine. – December 20, 2020.