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Last Updated : Oct 20, 2020 10:44 PM IST | Source: Reuters

AstraZeneca US COVID-19 vaccine trial may resume as soon as this week

The sources, who were briefed on the matter but asked to remain anonymous, said they have been told the trial could resume later this week.

Reuters

AstraZeneca Plc's COVID-19 vaccine trial in the United States is expected to resume as early as this week after the US Food and Drug Administration completed its review of a serious illness, four sources told Reuters.

AstraZeneca's large, late-stage US trial has been on hold since September 6, after a participant in the company's UK trial fell ill with what was suspected to be a rare spinal inflammatory disorder called transverse myelitis.

The sources, who were briefed on the matter but asked to remain anonymous, said they have been told the trial could resume later this week. It was unclear how the FDA would characterize the illness, they said.

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The FDA did not respond to a request for comment.

COVID-19 Vaccine

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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.

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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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The agency is requiring researchers conducting the trial to add information about the incident to consent forms signed by study participants, according to one of the sources.

UK regulatory officials previously reviewed the illness and determined there was “insufficient evidence to say for certain” that it was or was not related to the vaccine. It permitted the trial to resume enrolling participants in the UK, according to a draft of the updated consent form shared with Reuters.

“In this case, after considering the information, the independent reviewers and MHRA (Medicines and Healthcare products Regulatory Agency) recommended that vaccinations should continue,” the draft consent form stated. “Close monitoring of the affected individual and other participants will be continued.”

Regulators in Brazil, India and South Africa also previously allowed AstraZeneca to resume its vaccine trials there.

Responding to a request, British regulators shared with Reuters a draft of a form letter to UK vaccine trial participants, dated Oct. 14 and signed by the Oxford COVID-19 Vaccine Team. It says the U.S. FDA had “completed their analysis” and said vaccination in the United States would resume shortly.

FDA "has come to the same conclusion as the other drug regulators including the MHRA," the letter states. The regulator, Health Research Authority, did not say if the letter had been sent or immediately respond to questions about it.

An AstraZeneca spokeswoman said the communication is not from the company and it "cannot verify the content," referring to the draft letter to patients.

"We also cannot comment on a pending FDA decision," she said.

Follow our full coverage of the coronavirus pandemic here.
First Published on Oct 20, 2020 10:43 pm
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