Bangladesh drug regulator authorises Pfizer vaccine for emergency use

The Directorate General of Drug Administration has given emergency use authorisation to the coronavirus vaccine developed by US drugmaker Pfizer and German biotechnological company BioNTech.

The Directorate General of Health Services announced the decision on Thursday after a review of the safety and efficacy data of the vaccine being widely used in the West.

This is the fourth COVID-19 vaccine to get emergency use authorisation in Bangladesh.

The authorities had first approved the vaccine developed by the University of Oxford and AstraZeneca before beginning the mass immunisation drive on Feb 7.

After the manufacturer of the vaccine, the Serum of India, failed to send promised doses due to an export ban by the Indian government, Bangladesh scrambled to secure vaccine from other sources. India is struggling to bring under control a deadly second wave of infections.       

The government recently approved Russia’s Sputnik V, and the vaccine of China’s state company Sinopharm.

The authorities began administering 500,000 doses of the Chinese vaccine sent as a gift on Wednesday.

China is sending 600,000 more doses as gift, but commercial supply is unlikely to begin in the first half of this year, according to officials.

Although Pfizer began exporting US-made doses by the end of April, Bangladesh had shown little interest in the vaccine considering the fact that the country has not enough logistics to store and transport the shot, which requires to be stored at -70 degrees Celsius.

In Bangladesh, only the Public Health Institute, IEDCR, and icddr,b have the refrigerators with such low temperature, according to ABM Khurshid Alam, the director general of DGHS.

The health ministry said earlier this month that the global programme, COVAX, is sending at least 100,000 Pfizer doses in early June.     

Considering the size of the vials for 3mm vaccine containing 10 doses, Bangladesh will initially be able to store the shots and give them to people only in Dhaka, Alam said.

Bangladesh expects 68 million doses of COVID vaccines from the facility led by the World Health Organization to cover 20 percent of the population with two doses per citizen.

MRNA TECHNOLOGY

The Pfizer COVID-19 vaccine is based on BioNTech’s messenger RNA or mRNA platform.

It showed over 90 percent effectiveness in trials and is playing a major role in controlling the pandemic that has killed nearly 3.5 million people worldwide.

Messenger RNA vaccines work by inserting synthetic mRNA that instructs cells to make a pathogen’s proteins or protein bits, spurring the immune system into action.

Now, the United States and European Union are pushing to stock up on even more of the mRNA vaccines. Japan is also working to secure 100 million doses of Pfizer’s shot by the end of June.

But the higher cost, production limits and demanding requirements for shipping and storage could limit mRNA-based vaccines' availability in lower income countries.

Pfizer will however deliver through the international vaccine-sharing facility COVAX some of the 2 billion COVID-19 vaccine doses it announced last Friday as new supplies for low- and middle-income countries.

The vaccine offered 88 percent protection against the variant first sampled in India, only a slight drop from the 93 percent protection given against the variant from Britain, Public Health England said.

A first dose of the vaccine provided only about 34 percent protection against the variant first seen in India, a relatively steep drop from the roughly 51 percent protection a single dose of either of those vaccines offer against the earlier variant from Britain.

The Pfizer vaccine was originally authorised in the US for a three-week interval between doses.

However, several countries, including the UK, chose to expand this to a 12-week interval to allow a higher percentage of the population to receive one vaccine dose quicker.

[With more details from Reuters]