Monday, August 23, 2021

US FDA approves first Covid-19 vaccine! Thank God!

 

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US FDA approves first Covid-19 vaccine

By Melissa Macaya, Mike Hayes, Meg Wagner and Veronica Rocha, CNN

Updated 3:58 p.m. ET, August 23, 2021
3 Posts
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6 hr 4 min ago

FDA grants full approval to Pfizer's Covid-19 vaccine

From CNN's Jacquelien Howard

Vials containing doses of the Pfizer COVID-19 vaccine are viewed at a clinic on April 9, 2021 in Los Angeles, California. 
Vials containing doses of the Pfizer COVID-19 vaccine are viewed at a clinic on April 9, 2021 in Los Angeles, California.  Mario Tama/Getty Images

The US Food and Drug Administration on Monday granted full approval to the Pfizer/BioNTech Covid-19 vaccine for people age 16 and older. This is the first coronavirus vaccine approved by the FDA, and is expected to open the door to more vaccine mandates.

The Pfizer/BioNTech vaccine has been authorized for emergency use in the United States since mid-December for people age 16 and older. In May, the authorization was extended to those 12 and older.

Out of more than 170 million people in the United States fully vaccinated against Covid-19, more than 92 million have received the Pfizer/BioNTech vaccine.

Albert Bourla, the chair and chief executive officer of Pfizer, said the decision reaffirms the vaccine's safety.

“Based on the longer-term follow-up data that we submitted, today’s approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed. I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity. Hundreds of millions of doses of our vaccine already have been administered in the U.S. since December 2020, and we look forward to continuing to work with the U.S. government to reach more Americans," Bourla said.
7 hr 12 min ago

Covid-19 hospitalizations in unvaccinated cost US health system $2.3 billion in June and July, analysis shows

From CNN's Naomi Thomas

Clinicians work while caring for COVID-19 patients in the improvised COVID-19 unit at Providence Holy Cross Medical Center in the Mission Hills neighborhood on July 30, 2021 in Los Angeles, California. 
Clinicians work while caring for COVID-19 patients in the improvised COVID-19 unit at Providence Holy Cross Medical Center in the Mission Hills neighborhood on July 30, 2021 in Los Angeles, California.  Mario Tama/Getty Images

Covid-19 hospitalizations in unvaccinated people cost the US health system $2.3 billion in June and July alone, a number which is likely an understatement, according to an analysis from the Kaiser Family Foundation published Friday.

KFF looked at various sources, including CMS data and analyses of private claims, to find that the average cost of a Covid-19 hospitalization was around $20,000.

They used Health and Human Services and US Centers for Disease Control and Prevention data to find the number of preventable Covid-19 hospitalizations in the US in the months of June, 37,000 preventable hospitalizations, and July, 76,000 preventable hospitalizations. 

“If each of these preventable hospitalizations cost roughly $20,000, on average, that would mean these largely avoidable hospitalizations have already cost the U.S. health system billions of dollars since the beginning of June,” the analysis says.

For this estimate, they looked at those who were hospitalized primarily due to Covid-19 and adjusted that number to reflect the fact that even if unvaccinated adults had got the vaccine, it would not prevent 100% of hospitalizations. Then they multiplied the number of preventable hospitalizations by the cost of each hospitalization, using a typical cost of $20,000.

“Based on our estimates, described below, we find preventable Covid-19 cost the U.S. health system $2.3 billion in June and July 2021,” the analysis says.

However, the analysis noted that “this ballpark figure is likely an understatement of the cost burden on the health system from treatment of Covid-19 among unvaccinated adults.” KFF gives a few reasons for this, including that cases, hospitalizations and deaths have continued to increase into August, outpatient treatment costs were not included in the analysis and neither were costs from the unvaccinated spreading the virus to those who have taken the measures to protect themselves.

The cost of treating the unvaccinated is borne not only by patients but also society more broadly, KFF says, including taxpayer-funded public programs and private insurance premiums.

Patients only pay a small share of the cost of hospitalization directly themselves, the analysis says. Insurers are also prohibited from charging higher premiums to unvaccinated people by the Affordable Care Act and other laws, although employers could impose higher costs through wellness programs.

Private insurers have also begun to reinstate cost-sharing for Covid-19 hospitalizations, KFF says, and adults can largely avoid these costs, as well as severe illness, by getting a vaccine, which is free.

7 hr 33 min ago

Full FDA approval for the Pfizer Covid-19 vaccine could come as soon as today

From CNN's Hollie Silverman

A syringe is filled with a first dose of the Pfizer Covid-19 vaccine at a mobile vaccination clinic during a back to school event offering school supplies, Covid-19 vaccinations, face masks, and other resources for children and their families at the Weingart East Los Angeles YMCA in Los Angeles, California on August 7, 2021. 
A syringe is filled with a first dose of the Pfizer Covid-19 vaccine at a mobile vaccination clinic during a back to school event offering school supplies, Covid-19 vaccinations, face masks, and other resources for children and their families at the Weingart East Los Angeles YMCA in Los Angeles, California on August 7, 2021.  Patrick T. Fallon/AFP/Getty Images

Full approval from the US Food and Drug Administration of the Pfizer/BioNTech vaccine is "imminent," a senior federal official told CNN last week. Another official said the approval could come in the next two weeks or as early as today.

Once it happens, it could help allay concerns for those who are vaccine hesitant, as all three vaccines available in the US have so far been distributed under emergency use authorization.

The approval could also help businesses, schools and states enforce vaccine mandates, experts have said. Such mandates could help quell the ever-growing number of cases, especially in states that are experiencing a lack of available intensive care unit beds.


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