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Pfizer Covid-19 Vaccine Gets Full Approval by the FDA

Pfizer Covid-19 Vaccine Gets Full Approval by the FDA
The Pfizer/BioNTech coronavirus vaccine was approved by the US’ Food and Drug Administration on Monday after months of study. U.S. Navy photo by Mass Communication Specialist 1st Class Kegan E. Kay. Public Domain

The Pfizer-BioNtech Covid-19 vaccine finally got full approval by the FDA today after months of study. The vaccine was the first on the world market.

The vaccine had been given priority review treatment by the FDA as of July 20, when it was granted the designation. This step marked the last hurdle that had to be cleared in order for the vaccine — the very first to come onto the world scene, being approved for emergency use back in December of 2020 — to be distributed and marketed like any other inoculation on the market.

US health officials are hoping that the final clearance given by the nation’s highest health authority will lead not only to policy changes on the US and state level but to an increase in public acceptance of the vaccine, reflected in an increased inoculation rates among Americans who have proven hesitant to it.

Now, the way might be paved for sweeping, across the board vaccination requirements on the part of both public and private organizations and corporations, as the last legal loophole appeared to have closed for those who are against vaccine mandates.

Vaccine approved as states, cities, companies and universities have already imposed own mandates

The FDA’s approval may also signal that the vaccines will win final approval in the European Union as well. It is now before the EMA, the EU’s medicines authority.

Many US schools and universities have already stated that vaccinations will be mandatory for all returning students – and even that masking will be required for those who are vaccinated.

Vivek Murthy, the surgeon general of the United States, told interviewers form CNN on Sunday that he thought full FDA approval would have a real impact on millions of Americans who remain wary of the vaccine.

“This may tip them over toward getting vaccinated,” he stated, before adding that he expected corporations, state leaders and schools to impose mandates when the vaccines cleared the final hurdle. “We already know that there are many businesses and universities that have moved toward vaccine requirements,” he said, even before the inoculations were granted final approval.

Even before Monday’s approval, the Pentagon had stated that coronavirus vaccinations would be mandatory for its 1.3 million active-duty troops by the middle of September — but this deadline would be moved up if the FDA granted the designation earlier than that time.

The Pfizer Covid-19 Vaccine getting full approval from the FDA may help the 45% of Americans who are hesitant

As of now, there is still widespread vaccine hesitancy as 45 percent of Americans who remain unvaccinated state that they will “definitely” not not receive the inoculation willingly. Now that the Pfizer Covid-19 Vaccine has gotten full approval by the FDA, perhaps new, more wide-ranging restrictions may come into force regarding employment, entertainment and entrance to all public buildings.

In addition, there may even be an increase in insurance premiums for those who refuse the inoculation, according to a report from the New York Times. 

New York City will require at least one vaccine dose for all those who want to enter indoor restaurants and gyms or take part in cultural events beginning in the middle of September. Other cities, such as San Francisco and Boston, are following that lead as they put the pressure on the public to become inoculated as the Delta variant of the coronavirus sweeps across the country.

Boston’s acting Mayor Kim Janey said last Thursday that city workers must either become vaccinated or submit to regular testing by mid-October.

With the Delta variant causing infections to spike in the Commonwealth, Janey said the mandate will apply to all 18,000 of Boston’s city employees.

In San Francisco, as of August 20, all members of the public had to either show proof of vaccination before entering many places of business including gyms, theaters, restaurants and other areas that are considered places posing a high risk of infection.

Booster shots already recommended for the immunocompromised

Meanwhile, a third, or booster, dose of the Pfizer and Moderna vaccines is now being recommended for those who are immunocompromised, according to a decision made last week by the Centers for Disease Control and Prevention.

As of now, the FDA is still studying the approval of the Moderna vaccine – the only other vaccine employing mRNA technology. Experts say that the approval many come as soon as early September.

The firm plans to submit all its information regarding possible booster shots next month as well.

Murthy had harsh words for all those spreading vaccine misinformation as the Delta variant continues to pose a threat to the normal operations of schools and businesses across the nation.

Regarding the rampant online misinformation that continues to circulate around the country and the world, Murthy stated “The speed, scale and sophistication with which it is spreading and impacting our health is really unprecedented,” in a recent appearance on CNN.

“And it’s happening largely, in part, aided and abetted by social media platforms.”

The Biden administration has repeatedly pressured social media companies such as Facebook to share more data about false and misleading information that is contained in posts on their sites, and to encourage them to try to stop the flow of the deleterious information as the variant infects many of those who are still not vaccinated.

At one point, the President even accused Facebook of “killing people” by allowing this false information to circulate on its platform, before  he walked that statement back later on.

Murthy, as the nation’s top physician, has issued a formal advisory in which he declared misinformation to be “an urgent threat” to public health in these coronavirus times.

Facebook — which has pushed back by publicly accusing the White House of scapegoating it — this week released its first public quarterly report about the most viewed posts in the United States, for the quarter that includes April, May and June.

After being asked about Facebook disclosing the popularity of a news article that was considered to reduce confidence in the vaccines, Murthy told interviewers that it reinforced that “there is a lot of misinformation circulating on these sites.”

“I will readily say that the sites have recognized that this is a challenge, and they’ve stepped up to do some things to reduce the spread of misinformation. And I credit them for that,” he said. “But it’s not nearly enough.”

“There are people who are superspreaders of misinformation,” he added. “And there are algorithms, still, which continue to serve up more and more misinformation to people who encounter it the first time. These are things that companies can and must change. And I think they have a moral responsibility to do so quickly and transparently.”

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