Covid: FDA approves Pfizer vaccine for emergency use in US

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The US Food and Drug Administration has authorised the Pfizer-BioNTech coronavirus vaccine for emergency use.

The agency said the authorisation was a “significant milestone” in the pandemic, which taken more than 295,000 lives in the US.

The vaccine, which offers up to 95% protection against Covid-19, was deemed safe and effective by the FDA.

President Donald Trump said the first vaccinations will take place “in less than 24 hours”.

“Today our nation has achieved a medical miracle,” Mr Trump said. “We have delivered a safe and effective vaccine in just nine months.”

Before the announcement on Friday night, the FDA had come under intense pressure from the Trump administration to approve the vaccine’s use.

The head of the agency, Stephen Hahn, was told to approve it for emergency use by Friday or quit, US media reported, although he called this “untrue”.

Health and Human Services Secretary, Alex Azar, told reporters earlier on Friday that his department would work with Pfizer to get the mass vaccination programme started by Monday or Tuesday.

The Pfizer vaccine has already received regulatory approval in the UK, Canada, Bahrain and Saudi Arabia. Like those countries, the US will give its first doses of the vaccine to the elderly, health workers and emergency crew.

Coronavirus deaths have been rising sharply since November in the US. On Wednesday, the country recorded more than 3,000 deaths – the highest total in a single day anywhere in the world.

Covid: When can I get vaccinated in the US?
Safety data on Pfizer jab released by US
How does the Pfizer vaccine work?
What has the FDA said?
“The FDA’s authorisation for emergency use of the first Covid-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said Mr Hahn.

He said the authorisation came after “an open and transparent review process” that ensured the vaccine met the “FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality”.

On Thursday, medical experts advising the FDA recommended the emergency-use authorisation. A 23-member panel concluded the vaccine’s benefits outweighed its risks.

Emergency use, the FDA said, is not the same as full approval, which would require Pfizer to file a separate application to secure.

“While not an FDA approval, today’s emergency use authorisation of the Pfizer-BioNTech Covid-19 Vaccine holds the promise to alter the course of this pandemic in the United States,” said Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research.

Has the FDA been leaned on?
On Friday, President Trump sent out an angry tweet calling the FDA a “big, old, slow turtle”, adding: “Get the dam vaccines out NOW, Dr Hahn. Stop playing games and start saving lives.”

The Washington Post said that White House chief of staff Mark Meadows had ordered Mr Hahn to approve the vaccine on Friday or submit his resignation, citing three sources.

But Mr Hahn told US media he had only been “encouraged to continue working expeditiously” on the vaccine’s approval, and that the media representation of the chief of staff’s phone call was “untrue”.

Amid the reports of White House pressure, President-elect Joe Biden said he wanted to make it clear to the public that they should have confidence in the vaccine, adding: “There is no political influence.”

How does the vaccine work?
The Pfizer/BioNTech vaccine was the first coronavirus jab to show promising results in the latter stages of its testing process.

It is a new type called an mRNA vaccine that uses a tiny fragment of genetic code from the pandemic virus to teach the body how to fight Covid-19 and build immunity.

“The vaccine contains a small piece of the [Covid-19] virus’s mRNA that instructs cells in the body to make the virus’s distinctive ‘spike’ protein,” the FDA said.

“When 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 [Covid-19].”

The vaccine is given as two injections, 21 days apart, with the second dose being a booster. Immunity begins to kick in after the first dose but reaches its full effect seven days after the second dose.

What could happen now it has been approved?
Operation Warp Speed says that vaccine deliveries will begin within 24 hours of approval.

“We have made sure that this vaccine will be free, for all Americans,” Mr Trump said in a recorded video posted to Twitter.

“We have already begun shipping the vaccine to every state and zip code in the country. The first vaccine will be administered in less than 24 hours.”

 

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    five more dice, that might be coated using a transparent cover.
    The dealer will then put eight or seven championships into a reddish purse,
    that will be later passed to the players. The intent of the game would be to allow gamers to try and get rid of the most quantity of championships out of the board while maybe not letting any of
    those additional players remove any one of these dice out of the board.

    If a player wins a jackpot, this player must replace each one of the dice they removed from your
    board. When a player looses a jackpot, then they have to attend until it alters before they
    are able to attempt to eliminate some other set of dice.

    The very first portion of the gambling treatment is fairly straightforward.
    The guidelines for gambling are fairly standard. Gamers are invited to place stakes which match exactly with
    the general casino total bank-roll (maybe not their personal
    bet amounts). Irrespective of what the final bet total is, all bets have
    been performed in the same way – throughout the traditional,
    multi-line gaming procedure at which the man betting pays
    off one line of money plus receives a matching line of money cash back.
    In virtually no limit game such as for instance Sic Bo,
    however, a player may additionally fold their bets before the final bettors have a possiblity
    to carry them.

    If a casino presents odds for specific matches, chances are often recorded in Roman numerals.
    There are a number of variations on the list of odds, though.
    For instance, from the No Limit Texas Holdem
    match, a new player could receive two pairs, but 3 cards in the event the kettle is not small.
    From the No Limit texas hold em game, players could receive one card two cards in case their initial
    bet was some pair. No matter the type of odds,
    however, gamers ‘ are always educated to set their bets in line with
    this likelihood. This ensures that at the event that their first bet wins, then they will have the opportunity to pick another bet in a better rate.

    Edge gambling is a popular way in most casino matches. At a live casino
    match, a border bettor will usually use two varieties of bets
    – one for a single apparatus, and one for two components.
    In an video match, however, there are no limits into the stakes.

    Edge players may frequently bet many times on an identical guess, some times doubling, or tripling the first bet amount.
    Because of this, they are a wonderful strategy whenever you have the opportunity
    to do so, and also you’ll be able to get off with paying more winnings out than your house pays out.

    When it has to do with selecting your best bets, think about the winning hand and the odds for every.
    Both factors will likely probably be utilised to establish which stakes
    will be the ideal. Generally in most court situations,
    if you’ve got the opposite hand, you will have the best likelihood of winning
    the pot; when you yourself have the ideal hand, then you also
    still stand a excellent probability of winning the marijuana.
    If you might have a exact high overall score, then but you’ve got much
    less of a possibility of winning at the complete rating.
    This can be where most slot players end up, because they do not want to lose too much
    money while they are inside the match.

  32. It is reasonable to say Sic Bo is really a remarkably popular casino sport from Asia since possible theoretically win large quantities money
    with this popular game (normally wager by people who
    have been at the minority with regard to the majority who gamble the
    minimal quantity allowed from the casinos). In addition it’s fair to state that a lot of the players find
    that match in an effort to try and earn a fast dollar.
    Some elderly players are brought on by the fact that they
    can win big and that they like to try and polish their chances of successful massive.
    This really is how the sicbo / Tai Sai hands per hour usually does occur.

    The trader typically starts away having ten or twenty or
    more championships, which can be covered with a clear cover.
    The trader will subsequently place seven or eight dice into a
    red bag, that will be subsequently passed to these
    players. The aim of the game would be for people to try and get rid of the
    maximum quantity of championships from the board while not letting
    some of those other people remove some of these dice from the plank
    . If a new player wins a jackpot, that player has to replace each one of the dice that they
    originally removed from the boardgame. If a player looses a jackpot,
    then they still must attend till it changes before they can attempt to eliminate some other pair of dice.

    The very first portion of this betting procedure is relatively simple.

    The rules for gambling are fairly regular. Players are encouraged to put stakes that fit with the overall casino total bankroll (maybe not their personal bet
    amounts). No matter what the final bet amount is, all stakes have been played at
    an identical manner – through the traditional, multi-line gaming procedure where the
    individual gambling pays off one lineup of currency plus receives a
    matching line of currency ahead. At virtually no limit game such as
    Sic-Bo, though, a new player may additionally fold their stakes before the final bettors have a possiblity
    to take them.

    If a casino presents chances for specific games, odds are usually listed in Roman numerals.
    There are a number of variations on the list of odds, although.
    As an example, in the No Limit Texas Holdem game, a player can receive two pairs, however a few
    cards if the bud remains not small. From the No Limit Texas Holdem match, people may receive a single card
    two cards if their original wager has been some pair.

    Whatever type of chances, however, players ‘ are always educated to place their
    bets according to the likelihood. This ensures that at
    the event that their first bet wins, they have the chance to select
    another bet in a higher rate.

    Edge gambling is a popular strategy in most casino
    gambling games. In an online casino game, a border bettor will often utilize two different types of stakes –
    one for a single unit, and one for 2 units. At an internet video game, however,
    there are no limits into the bets. Edge people may frequently bet a
    number of times over the same guess, sometimes doubling, or tripling the initial bet amount.
    Because of this, they are a really good strategy when you have
    the opportunity to do so, and you can become off with paying more winnings
    out than your house pays out.

    If it comes to selecting your best bets, consider the winning hands and
    also the chances of every. Both of these factors will
    be used to identify which bets are the ideal. Generally in most situations, when you have the opposite hand,
    you are going to possess the greatest likelihood of winning the pot;
    when you yourself have exactly the ideal hand, then you also still stand a very
    good possibility of winning the pot. For those who possess a very high total score, but you have much less of
    a possibility of profitable the complete score. This is really where many casino players wind upward, as
    they usually do not want to lose too much money whenever they are within the game.

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