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US FDA issues emergency use authorisation for Moderna covid
vaccine |

The US has approved Moderna vaccine for covid to be
administered in the country. A week ago it had approved
Pfizer's vaccine which is currently being given on a priority
basis. The first country to ever use a covid vaccine (Pfizer) was
the UK. |
WASHINGTON, Dec 18: The US Food and Drug Administration (FDA) issued EUA (Emergency
Use Authorisation) for Moderna covid vaccine on Friday. The emergency use authorization
allows the vaccine to be distributed in the US for use in individuals 18 years
of age and older, the FDA said.
This is the second covid vaccine the US has approved after Pfizer's, which
is currently being administered on a priority basis.
Pfizer's was the first vaccine to be administered in the world against covid.
And the first country to use it was the UK. The UK's Medicines and Healthcare
products Regulatory Agency (MHRA) had given authorisation for Pfizer vaccine
on December 2 and the vaccination started on December 8.
On December 11 the FDA approved the Pfizer's vaccine after President Donald
Trump threatened the FDA chief and the vaccination started on December 14.
Moderna has 20 m doses ready for the month to be distributed in the US. In
the first quarter of 2021 the pharma will supply 85 to 100 m doses to the US.
It plans to manufacture a total of 500 m to 1 b doses in 2021. All vaccines
being developed across the world need two doses separated by two-three weeks
time gap, except Johnson & Johnsosn.
Like Pfizer, Moderna also uses the latest technology of mRNA. "The (mRNA) (genetic
) code instructs cells in the body to make the virus's distinctive 'spike' protein,"
which works as the vaccine, the FDA said.
mRNA is a new technology being used in human beings for the first time. Apart
from Pfizer and Moderna, one more pharma, Pune's (India) Gennova is using this
tech.
An FDA statement said:
"The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic
material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA
that instructs cells in the body to make the virus’s distinctive “spike” protein.
After a person receives this vaccine, their body produces copies of the spike
protein, which does not cause disease, but triggers the immune system to learn
to react defensively, producing an immune response against SARS-CoV-2.
"Moderna COVID-19 Vaccine is administered as a series of two doses, one month
apart. The available safety data to support the EUA include an analysis of 30,351
participants enrolled in an ongoing randomized, placebo-controlled study conducted
in the U.S. These participants, 15,185 of whom received the vaccine and 15,166
of whom received saline placebo, were followed for a median of more than two
months after receiving the second dose. The most commonly reported side effects,
which typically lasted several days, were pain at the injection site, tiredness,
headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm
as the injection, nausea and vomiting, and fever. Of note, more people experienced
these side effects after the second dose than after the first dose, so it is
important for vaccination providers and recipients to expect that there may
be some side effects after either dose, but even more so after the second dose."
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