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Coronavirus

FDA Issues Emergency Use Authorization for Second COVID-19 Vaccine

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On Friday, the U.S. Food and Drug Administration granted emergency use authorization for the second vaccine produced by Moderna.

What We Know:

  • Just last week, the FDA endorsed the Pfizer-BioNTech Covid-19 vaccine as the first for emergency use in the United States. Health care workers and nursing home employees were among the first to receive doses of the vaccine on Monday.
  • Moderna, a biotechnology company based in Cambridge, Massachusetts, developed the second authorized vaccine in partnership with Dr. Anthony S. Fauci’s agency at the National Institutes of Health. In an interview, Dr. Fauci stated the emergence of the two vaccines was “a historic moment”.
  • FDA Commissioner Stephen M. Hahn, M.D said, “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.” Although both vaccines were permitted under an accelerated timeframe, Hahn assures the FDA adhered to the rigorous measures for safety, effectiveness, and manufacturing quality that are all necessary to establish emergency use authorization.
  • Moderna’s vaccine, also known as mRNA-1273, holds messenger RNA which carries genetic code from DNA. The vaccine has a small portion of the coronavirus’ RNA that tells the body to create the virus’ spike protein. Once the vaccine enters the body, it makes copies of the spike protein triggering the immune system to teach itself to respond defensively, therefore building the immune system’s counter against Covid-19.
  • Unlike Pfizer’s vaccine, Moderna’s vaccine is only for individuals 18 years and older. Yet similar to Pfizer-BioNTech’s vaccine, Moderna’s vaccination also requires two injections, but instead of a 21-day interval, Moderna doses are 28 days apart.
  • In a clinical trial, mRNA-1273 had an efficacy rate of 94.1% in preventing symptomatic coronavirus infection within two weeks following the second dosage. Pfizer’s trials showed a 95% efficacy rate. Currently, the amount of time the Moderna vaccine will grant protection from the virus cannot be determined with the given data. There is also no proof that it will stop the transmission of Covid-19 between people.
  • By next week, the federal government plans to allocate nearly 5.9 million doses of Moderna’s coronavirus vaccine to 64 major cities, states, and territories across the United States. This will be done with the funding of Operation Warp Speed, a program that develops and distributes vaccines as fast as possible. The Massachusetts-based biotech company expects to make 20 million doses, primarily for frontline healthcare workers and nursing home residents, by the end of the month and at least a billion doses in 2021. 

Dr. Fauci believes the presence of these vaccinations in under a year “is a triumph multiyear investment in biomedical research.” He says, “this is an example of government working. It worked really well.”

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Alex Haynes is Editor-At-Large/NYC Editor at Urban Newsroom, Executive Editor at UNR's Black Alerts and the host of Boss Mornings and Unmuted Nation. Alex joined Urban Newsroom in 2010 and contributes regular op-ed and editorial pieces while advising the columnist and contributing staff.

Coronavirus

U.S. May Approve COVID-19 Booster Shots at 6 Months

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The Food and Drug Administration (FDA) is currently reviewing booster data from vaccine manufacturers and other countries given at 6 months.

What We Know:

  • An unnamed source told the Wall Street Journal the boosters would be approved for all three COVID-19 vaccines administered in the US- Pfizer, Moderna, and Johnson & Johnson. In addition, they declared approval would come in mid-September.
  • The information comes after officials reported that booster shots would become available to some adults 8 months after their last dose beginning on September 20. These include healthcare providers, nursing home residents, and other seniors. However, booster rollout depends on FDA approval and recommendation from a key Centers for Disease Control and Prevention (CDC) outside vaccine advisory committee.
  • Officials want people to receive the third dosage because of the current rise in Delta strain cases. Studies show that the coronavirus vaccine loses potency after several months. Additionally, the Delta strain currently holds the highest number of infections among vaccinated and unvaccinated people; despite this, those who obtained the vaccine experience milder breakthrough infections.
  • In addition, the CDC and FDA urge citizens to receive vaccinations as hospitalizations rise once more. Recently, the U.S. saw 100,000 people hospitalized, a number only seen since before vaccines were easily accessible. A third of the country’s hospitalizations come from states with low vaccination rates, large populations, and governors who disagree with vaccine and mask mandates, such as Texas and Florida. As of Aug. 25, Texas saw 23,412 new daily cases, 248 deaths, and 14,000 hospitalizations. On that same date, Florida saw 26,203 positive cases, 9 fatalities, and 17,000 hospitalizations.

Alongside more hospitalizations, daily numbers are also creeping back up. On Aug. 25, the U.S. saw 148,000 new cases, only 3,000 less than Jan. 30’s report. In contrast, deaths from COVID-19 waned since January, dropping from 3,100 a day to 1,100 a day.

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FDA grants full approval to Pfizer’s Covid vaccine

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The Food and Drug Administration granted full approval to Pfizer-BioNTech’s two-dose vaccine Monday for people ages 16 and up, making it the first Covid-19 vaccine to pass this final regulatory hurdle.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the Covid-19 pandemic,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement. “While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

What We Know:

  • The FDA’s decision may also pave the way for more vaccination mandates: Many businesses were waiting for full approval before they required employees to be vaccinated.

“Full approval could not come at a more important time, as the highly contagious delta variant continues to drive up caseloads and deaths across the U.S.,” the president and CEO of the Robert Wood Johnson Foundation, Dr. Richard Besser, former acting director of the Centers for Disease Control and Prevention, said in a statement. “I am hopeful that full approval will address any remaining concerns and will move many people to a ‘yes’ on vaccination.”

  • Besser said the lack of vaccines in middle- and low-income countries “represents a global failure,” adding, “Ensuring an adequate supply of vaccines in every country and community must be a health, economic, and moral imperative for the world.”
  • Federal health officials announced that, starting September 20th, people who received the Pfizer vaccine will be eligible for third doses eight months after their second doses. The FDA has not yet signed off a third dose.  No Covid vaccines have been authorized or approved for use in children under 12, though this is expected to change soon with FDA approval.

Pfizer’s vaccine is one of three in use in the U.S. Moderna has also applied for full approval, also known as a Biologics Licensing Application. Johnson & Johnson has not yet applied for full approval, and remains in use under emergency authorization.

Pfizer’s product was the first Covid vaccine to gain emergency use authorization, in December. As of Monday, more than 203 million doses have been given in the U.S., according to the CDC.

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Coronavirus

Reverend Jesse Jackson and His Wife, Jacqueline, Hospitalized with COVID-19

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Reverend Jesse Jackson and his wife Jacqueline are currently being treated at Northwestern Memorial Hospital in Chicago.

What We Know:

  • News about the couple’s diagnosis became public after a statement released by the Reverend’s Rainbow/Push Coalition on Saturday. In the statement, officials declared that doctors were monitoring both Jesse and Jacqueline; it did not provide any further information.
  • However, their son, Jonathan, provided more information on Sunday. Jonathan told the Associated Press that doctors are carefully observing Jesse and Jacqueline because of their ages. Additionally, the two responded “positively” to treatments and were resting. On Monday, Jonathan said his parents’ status did not change and asked for prayers for the two,
  • Despite his hospitalization, Jesse received his first coronavirus vaccine dosage in January 2021 during a publicized event. Alongside obtaining protection against the disease, he urged his followers to receive the vaccine as soon as possible. The Associated Press reported that it is unclear if Jacqueline also got the vaccine.
  • Underlying health concerns might have been the cause for both of them catching COVID-19. Family members said Jacqueline had an unspecified condition which made them concerned recently. In addition, Jesse was diagnosed in 2015 with Parkinson’s disease and underwent gallbladder surgery earlier this year.
  • Rev. Jesse Jackson worked with mentor Dr. Martin Luther King, Jr. in moving the Civil Rights Movement forward. His impact helped guide the movement on numerous issues, such as voting rights. After the movement and even currently, Jesse continued working to make a change in his society. Police recently arrested Jesse for civil disobedience after participating in a sit-in at Sen. Kyrsten Sinema‘s Phoenix office with 39 others.

Black News Alerts prays that Jesse and Jacqueline make a speedy recovery and continue inspiring many.

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