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Coronavirus

U.S. Government Gives Moderna Inc. $472 Million for COVID Vaccine

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Moderna Inc., a Cambridge, MA biotech company, announced on Sunday that they received additional funding from the U.S. government’s Biomedical Advanced Research and Development Authority (BARDA) in the amount of $472 million.

What We Know:

  • The additional funding will support the expansion of the Phase 3 study of their COVID-19 vaccine candidate (mRNA-1273), which began Monday in Savannah, GA in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and BARDA. Phase 3 is a wide-spread human trial in order to test the vaccine’s safety and efficacy. Moderna’s study will be tested at 89 U.S. sites and, due to additional funding, will be able to include approximately 30,000 healthy participants. They are the first in the United States to begin human trails for a Coronavirus vaccine.
  • Dr. Anthony Fauci, the director of NIAID, claims that early results from the Phase 3 study may be available in November or December if the trial enrolls quickly in places with high case loads. The study will use public health data to identify high-incidence areas and epicenters so sites near the locations can be prioritized for enrollment. Fauci says that, “The trail is designed to show the vaccine is at least 60% effective in preventing COVID-19”.
  • In April, the company received $483 million from BARDA while the vaccine was still in the early stages of trials by the U.S. National Institutes of Health. Including the recent addition, this puts the company’s total BARDA funding at $955 million.
  • Moderna and NIAID collaborated in the development of the vaccine and the conduct of the Phase 1 study. On July 10, the company surpassed Phase 2 of the study in collaboration with BARDA – which included 600 participants. According to BARDA, “The vaccine candidate received Fast Track Designation from the U.S. Food and Drug Administration (FDA) in May”.
  • According to CEO, Stéphane Bancel, the company is encouraged that their vaccine may help address the current pandemic and prevent future outbreaks of the disease. Because the vaccine uses a synthetic RNA to fight the virus, it may be able to immunize the body against the virus and has potential for faster development and manufacturing. The company claims they are on track for a 2021 production of about 500 million to 1 billion doses per year.
  • On Monday, the U.S. Department of Health and Human Services expanded manufacturing capacity for the possible vaccine by reserving the Center for Innovation in Advanced Development and Manufacturing (CIADM) at Texas A&M University. The CIADM is a public-private partnership between BARDA and Texas A&M University System, with manufacturing subcontracted by FUJIFILM Diosynth Biotechnologies. The task values at about $265 million and would reserve the manufacturing expansion through December of 2021 for U.S. government partners developing vaccines under Operation Warp Speed, which was set out by President Donald Trump.
  • As the possibility of a preventative vaccine increases, the stock market has been more engaged, with the Moderna stock spiking when the Phase 1 results showed promise. Since then, it has risen and fallen periodically. However, it brings into question the possibility of President Trump’s reelection. Some analysts are claiming that if the vaccine were to be approved, manufactured, or even show some sort of promise by the November election, it may increase Donald Trump’s chances of winning. Between the stock market reengaging and the possibility of control over the virus, it could be that this vaccine is the boost Trump needs.

As the trial continues, scientists are hopeful to find a preventative measure to the virus. To sign up to be apart of the trial at your local site, visit here.

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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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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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