Moneycontrol PRO
you are here: HomeNewsTrendsHealth

AstraZeneca to seek US approval of COVID-19 vaccine in 2nd half

The Anglo-Swedish drugmaker announced the schedule as it released second-quarter financial results, which showed that the company and its sub-licensees delivered more than 700 million doses of the vaccine to over 170 countries in the first half of this year. That includes 80 million doses that went to the COVAX initiative for low- and middle-income countries.

July 29, 2021 / 02:13 PM IST

AstraZeneca said on Thursday that it intends to seek US authorization for its COVID-19 vaccine in the second half of this year, offering a new timetable for the much-delayed application.


The Anglo-Swedish drugmaker announced the schedule as it released second-quarter financial results, which showed that the company and its sub-licensees delivered more than 700 million doses of the vaccine to over 170 countries in the first half of this year. That includes 80 million doses that went to the COVAX initiative for low- and middle-income countries.


The news on the US filing is being closely watched, as the timeframe has slipped.


Follow our LIVE blog for latest updates of the novel coronavirus pandemic

When AstraZeneca released data from its US trial of the vaccine on March 22, company officials said they expected to seek authorization from the Food and Drug Administration in the first half of April. In April, the company said it expected to submit a US application in the “coming weeks.


The UK, European Union and World Health Organization have already authorized use of the AstraZeneca vaccine.

Close

COVID-19 Vaccine

Frequently Asked Questions

View more
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.

View more
Show

AstraZeneca reported first-half revenue of $1.17 billion from deliveries of 319 million doses of the vaccine that were supplied directly by the company. AstraZeneca has pledged to deliver the vaccine on a non-profit basis as long as the pandemic lasts.


Despite complaints from the EU about its vaccine supply, the 27-nation bloc received more doses directly from AstraZeneca than any other single entity in the first half of the year. The company shipped 97 million doses to the EU, while Brazil got 65 million and the UK 52 million,


AstraZeneca said. Gavi, an alliance that secures vaccines for low-income countries, received 49 million doses, and another 57 million doses went to other countries.


Sub-licensees, including the Serum Institute of India, supplied millions more doses, pushing global deliveries to more than 700 million doses.


The vaccine was developed by Oxford University researchers, who licensed the technology to AstraZeneca in an effort to tap into the company’s global manufacturing and distribution capacity. AstraZeneca, in turn, authorizes other companies to produce the shots around the world.

Follow our full coverage of the coronavirus pandemic here.
Associated Press
first published: Jul 29, 2021 02:13 pm
Sections
ISO 27001 - BSI Assurance Mark