Moderna Inc’s coronavirus vaccine
on Friday became the second to receive emergency use authorization from the US
Food and Drug Administration (FDA); welcome news to a nation with a staggering
Covid-19 death toll of over 307,000 lives lost. Millions of doses of the
Moderna vaccine are expected to be added to the US rollout; which began this
week with healthcare workers. Older people in long-term care facilities are
next in line for vaccines; with a US Centres for Disease Control and Prevention
expert panel on Sunday set to recommend what groups follow; as industries
compete to have their workers given precedence. The FDA announced the authorization
the day after the agency’s panel of outside experts endorsed its use and a week
after the FDA authorized a vaccine from Pfizer Inc and German partner BioNTech
SE. The vaccine from Pfizer and BioNTech; based on similar technology; has been
put into the arms of thousands of US healthcare workers this week in a massive
nationwide rollout. Moderna injections are expected to begin in coming days for
adults 18 years old and up. ‘With the availability of two vaccines now for the
prevention of Covid-19, the FDA has taken another crucial step in the fight
against this global pandemic that is causing vast numbers of hospitalizations
and deaths in the United States each day;’ FDA Commissioner Stephen Hahn; MD;
said in a statement. Moderna’s shot is expected to be used in harder-to-reach
locations, such as rural hospitals. The vaccine needs to be stored and shipped
frozen, but does not require the ultra-cold temperatures of the Pfizer/BioNTech
shot. The speed of vaccine development - less than a year from when the first
case of the new coronavirus was found in the United States - is a stunning
scientific success; although there is some hesitancy among the public. ‘It is
my hope that all Americans will protect themselves by getting vaccinated when
the vaccine becomes available to them. That is how our country will begin to
heal and move forward;’ top US infectious disease scientist Anthony Fauci said
in a statement. Moderna said it intended to apply for full US license in 2021. The
FDA decision marks the first regulatory authorization in the world for
Moderna’s vaccine and validation of its messenger RNA technology, shown to be
nearly 95 per cent effective with no serious safety concerns. It comes less
than a year after the first Covid-19 case was identified in the United States. The
vaccine; developed in partnership with the National Institutes of Health; had
relatively minor side effects including pain around the injection site and
swelling. The biotech company has worked with the US government to prepare for
the distribution of 5.9 million shots starting as early as this weekend. Once
thawed; the Moderna vaccine can be kept at typical refrigerator temperatures.
It is administered in two shots 28 days apart. Between the two vaccines; the
United States is expecting 40 million doses before year end; enough to
eventually vaccinate 20 million people, as both require two shots. ‘Brighter days
lie ahead;’ responded US President-elect Joe Biden, who plans to be vaccinated
on Monday. US President Donald Trump on Twitter hailed the authorization. ‘Congratulations;
the Moderna vaccine is now available!’ he wrote. The vaccine must be
transported to hospitals and other centres before injections begin. Moderna
said it would deliver approximately 20 million doses to the US government this
year and expected to have between 100 million and 125 million globally in the
first quarter of next year; with 85-100 million of those for the United States.
Moderna has deals with the US government to provide a total of 200 million
doses by the end of June 2021. Other vaccines still are in testing; including a
one-shot injection from Johnson & Johnson; and a two-shot course from
AstraZeneca and Oxford University. US hospitalizations and deaths have surged;
driven by last month’s Thanksgiving holiday gatherings. Authorities have
renewed restrictions and shutdowns across the country. Public health officials
have warned infections from Christmas and New Year’s celebrations could
exacerbate a crisis that already threatens to overwhelm healthcare systems
nationwide. Even with two highly effective vaccines, practices such as social
distancing and face covering will be needed for months before enough people are
inoculated to curb virus transmission and eventually end the pandemic. ‘With
strong federal funding for swift vaccine rollout and education; and by
following the guidance of public health experts to continue wearing masks and
maintaining distance; we can bring the end of this pandemic closer;’ Barbara
Alexander; head of the Infectious Diseases Society of America; said in a
statement.
by: mhmaamay - mhmamay
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