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US loosens Pfizer vaccine shipping regulations

The Food and Drug Administration said Thursday that it's allowing the additional option after reviewing new data from New York-based Pfizer and its German partner, BioNTech.

February 26, 2021 / 08:00 AM IST

US regulators are allowing Pfizer's COVID-19 vaccine to be shipped and stored at less-frigid temperatures, which should ease distribution and administration of one of the two vaccines authorized for emergency use in the country.

The Food and Drug Administration said Thursday that it's allowing the additional option after reviewing new data from New York-based Pfizer and its German partner, BioNTech.

The FDA said the vaccine, which is shipped in frozen vials, now can be transported and stored for up to two weeks at the temperatures of freezers commonly found in pharmacies. That''s after Pfizer provided the FDA with data on Feb. 19 that showed its vaccine remains stable for up to two weeks at those standard freezer temperatures.

Until now, the vaccine was required to be kept at ultra-cold temperatures — from minus 112 degrees to minus 76 degrees Fahrenheit (minus 80 degrees to minus 60 degrees Celsius) — so Pfizer ships the vials in a special thermal container packed with dry ice to maintain that temperature range. That requirement meant vaccination sites had to either obtain expensive ultracold freezers, keep adding dry ice to the shipping container to keep to the correct temperature range, or administer all the doses in each shipment quickly so none spoiled.

Pfizer is studying effects of third vaccine dose as booster. Dr. Fauci says take whatever vaccine is available. Drug companies can tweak vaccines to adapt to variants, a process that should be easier than coming up with the original shots. China approves two more virus vaccines for wider use to reach four total vaccines. Medical oxygen scarce for coronavirus patients in Africa, Latin America.

COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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PTI
first published: Feb 26, 2021 08:00 am