COVID-19: FDA Authorizes Pfizer Vaccine Use Between 12-15 Years


The latest on COVID-19

Pfizer I

The United States Food and Drug Administration (FDA) authorized on Monday, May 10, the extension of emergency use of the Pfizer-BioNTech covid vaccine among children aged 12 to 15 years.

So far, Pfizer’s is the only licensed vaccine for people 16 years of age and older.

“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech covid-19 vaccine to include adolescents ages 12 to 15 is a significant step in the fight against the pandemic,” said the acting commissioner of the FDA, Janet Woodcock.

He added that “today’s action allows us to protect a younger population against covid-19, bringing us closer to returning to normal and ending the pandemic. Parents and guardians can rest assured that the agency conducted a rigorous and comprehensive review of all available data, as we have done with all of our emergency use authorizations for covid vaccines. “

From March 1, 2020 through April 30, 2021, approximately 1.5 million cases of covid-19 have been reported to the Centers for Disease Control and Prevention (CDC) in people ages 11 to 17. .

Children and adolescents generally have a milder form of the disease compared to adults.

The Pfizer-BioNTech covid vaccine is given as a two-dose series, three weeks apart, the same dose and dosing regimen for those over 16 years of age.

Pfizer II

Pharmaceutical Pfizer has applied to the United States Food and Drug Administration (FDA) for full authorization of its vaccine against covid-19 for people 16 years of age and older.

The vaccine obtained an emergency use authorization from the FDA on December 11, 2020. It is a designation that is granted when a drug or vaccine is showing encouraging results in large clinical trials, to avoid red tape that can take years until your authorization.

The other two that are approved for emergency use in the United States are Moderna and Johnson & Johnson vaccines.

Pfizer partnered with the German company BioNTech to produce a covid vaccine, which was obtained in record time – less than a year.

It is the first pharmaceutical company to request full authorization, which enables it to market the vaccine directly and generate new forms of the vaccine against new strains of coronavirus without having to request an emergency authorization again.

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This cradle use for teens 12-15 years of age is expected to be approved soon.

Pfizer has already delivered 170 million doses in the United States.

Vaccines for all

The Biden administration announced that it will support a controversial measure to exempt covid vaccines from intellectual property rights.

Giving up these rights would make it easier for some countries to export these vaccines, and for others to receive them.

The Biden administration clarified that it firmly believes in the intellectual property of a product, but that, in this case, at least temporarily breaking down the bureaucratic barriers that limit production and export would help to dramatically increase immunization, with the goal of ending the pandemic.

The proposal for this exemption had been submitted last fall by India and South Africa to the World Trade Organization.

“As our supply of vaccines to the American people is secured, the Administration will continue to intensify its efforts, working with the private sector and all possible partners, to expand vaccine manufacturing and distribution. It will also work to increase the raw materials needed to produce these vaccines, ”said Casa Banca in a statement.

More doses for teens

The U.S. Food and Drug Administration (FDA) may be authorizing Pfizer’s covid-19 vaccine for youth ages 12-15 the second week of May, setting up a massive new round of vaccines for many before the start of the next school year.

The process that must have the approval of the Centers for Disease Control and Prevention (CDC) will be faster because it would be an emergency authorization, as in the case of the adult version.

More expensive

The Centers for Disease Control and Prevention (CDC) of the United States said that fully immunized people (that is, two weeks after the second dose of the covid vaccine) can be outdoors without a mask if they go out for a run, walk, or bike ride, or if you plan to dine with friends at restaurants with tables outside.

Highlights of the changes to the CDC recommendations would be:

  • Fully vaccinated people no longer need to wear a mask outdoors, except in certain crowded places.
  • They stress that immunosuppressed people should consult their healthcare provider about these recommendations, even if they are fully vaccinated.
  • They clarify that fully vaccinated workers should no longer be restricted from work after exposure, as long as they are asymptomatic.
  • Fully vaccinated residents of congregated unsanitary settings (such as nursing homes) no longer need to self-quarantine after known exposure.
  • Fully vaccinated asymptomatic people without exposure can be exempted from routine screening tests, if possible.
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And lFully vaccinated people can:

  • Visiting other fully vaccinated people indoors without wearing masks or physical distancing
  • Visiting unvaccinated individuals (including children) from a single household who are at low risk for severe covid-19 disease indoors without wearing masks or physical distancing
  • Participate in outdoor and recreational activities without a mask, except in certain crowded places
  • Resume domestic travel, without the need for tests before or after the trip or self-quarantine after the trip.
  • Refrain from testing before leaving the United States for international travel (unless the destination requires it) and refrain from self-quarantine after returning to the United States.
  • Refrain from testing after known exposure, if asymptomatic, with some exceptions for specific settings
  • Refrain from quarantine after known exposure if asymptomatic
  • Refrain from routine screening tests if asymptomatic and feasible

For now, fully vaccinated people should continue:

  • Taking precautions in indoor public settings, such as wearing a tight-fitting mask
  • Wearing well-fitting masks when visiting indoors with unvaccinated individuals who are at increased risk of contracting a severe form of COVID-19 or who have an unvaccinated household member who is at increased risk of developing severe COVID.
  • Wear tight-fitting masks when visiting indoors with unvaccinated people from various households
  • Avoid large in-person meetings indoors
  • Get tested if you experience symptoms of covid-19
  • Follow the guidance issued by individual employers
  • Follow CDC and health department travel requirements and recommendations

Pfizer vaccine

Albert Bourla, CEO of pharmaceutical company Pfizer, said a third dose of the vaccine is likely to be needed six to 12 months after the second to boost immunity.

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This strengthens the idea that the covid vaccine could be seasonal, requiring an annual dose, as is the case with the flu vaccine.

Scientists still don’t know how long immunity lasts after the two doses.

Johns Hopkins University created a near real-time case map that you can also view and follow here:

  • Guide: how to prepare for coronavirus

What are coronaviruses

Coronaviruses (CoVs) are a broad family of viruses that can cause a variety of conditions, from the common cold to more serious illnesses, such as the Middle East respiratory syndrome coronavirus (MERS-CoV) and the one that causes respiratory syndrome. severe acute (SARS-CoV). A new coronavirus is a new strain of coronavirus that has not been found before in humans.

How do you get the coronavirus?

Coronaviruses can be transmitted from animals to people (called zoonotic transmission). Studies have shown that SARS-CoV was transmitted from the civet to humans and that transmission of MERS-CoV from dromedary to humans has occurred. In addition, it is known that there are other coronaviruses circulating among animals, which have not yet infected humans.

Characteristic symptoms

These infections usually cause fever and respiratory symptoms (cough and dyspnea or shortness of breath). In the most severe cases, they can cause pneumonia, severe acute respiratory syndrome, kidney failure, and even death.

Also headache and loss of taste and smell.

How to prevent contagion

The usual recommendations to avoid spreading the infection are to wash your hands frequently and cover your mouth and nose when coughing and sneezing (with your arm, not your hand). Masks should be used, especially indoors.

Close contact with anyone showing signs of a respiratory condition, such as coughing or sneezing, should also be avoided. Comply with 6-foot (two-meter) social distancing and stay home if symptoms appear.

Sources: WHO, CDC, Johns Hopkins.

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