Show an ad over header. AMP

I am the FIRST

FDA review of Pfizer vaccine clears way for emergency authorization

The FDA's vaccine advisory committee released a detailed analysis on Tuesday finding that Pfizer's coronavirus vaccine appears to meet the safety and efficacy requirements necessary for an emergency use authorization (EUA).

Why it matters: The FDA's initial review suggests that the agency will issue an EUA after its advisory committee meets on Thursday. The publication of the analysis comes the same day that the U.K. began administering its first doses of the Pfizer vaccine, which regulators cleared for emergency use last week.

Details: The FDA found that there are no specific safety concerns from Pfizer's vaccine by race, age, ethnicity, medical co-morbidities, or a prior COVID infection.

  • The most common negative side effects of vaccination were fatigue, headache, muscle pain, chills, joint pain, and fever.
  • Severe adverse reactions only occurred in 0.0% to 4.6% of Pfizer's study participants, and were more frequent after the second dose than the first dose. Adults under 55 experienced less serious side effects.
  • Pfizer's data suggests that the vaccine could help prevent COVID infections following the first dose, but available data did not allow for a firm conclusion, the FDA said.

Of note: Two people in the vaccine group died over the course of the study — one participant with pre-existing atherosclerosis and another participant that went through cardiac arrest after the second dose and died three days later.

The bottom line: The FDA writes that although Pfizer's data shows the vaccine is highly effective against symptomatic COVID-19 patients, data from more people is needed to determine how effective the vaccine is at saving lives.

  • It is also possible that the vaccine's efficacy against asymptomatic infection is lower than its efficacy against against symptomatic infection, per the FDA.
  • Additional testing is needed to see how effective the vaccine is in preventing the transmission of the virus.

What's next: The FDA's advisory committee will meet on Dec. 10 to discuss Pfizer's request for an emergency use authorization and whether further study on the vaccine is needed.

1 dead, 2 injured after pickup truck hits Pride spectators in Florida

A driver in a pickup truck hit spectators at a Pride festival in Wilton Manors, Florida, killing at least one person and wounding two others Saturday, according to Fort Lauderdale Mayor Dean Trantalis, per the SunSentinel.

The big picture: The incident at the Wilton Manors Stonewall Parade and Festival was one of two involving a pickup truck hitting a crowd on Saturday, with several cyclists left critically wounded in Arizona.

Keep reading... Show less

In photos: Brazilians rally against Bolsonaro as COVID deaths top 500,000

Demonstrators took to the streets in at least 22 of Brazil’s 26 states to protest President Jair Bolsonaro's handling of the pandemic — as COVID-19 cases surged past 500,000 on Saturday, per AP.

The big picture: Brazil has the world's second-highest coronavirus death toll and third-highest number of cases. Only 12% of the country's population has been vaccinated against the virus, AP notes.

Keep reading... Show less

Major companies ask Colorado residents not to apply for remote positions

Major companies have said in recent job postings that Colorado residents are ineligible to apply for certain remote positions because a new state law requires businesses to disclose the expected salary or pay range for positions, according to the Wall Street Journal.

Why it matters: The law, which went into effect in January, is meant to help close the gender wage gap and to promote wage transparency for employees, but companies have said Coloradans need not apply to avoid disclosing the information.

Keep reading... Show less

In photos: Communities across nation celebrate Juneteenth

People across the country are celebrating Juneteenth National Independence Day.

The big picture: The date, June 19, memorializes when some of the last enslaved people in Texas learned about their freedom under the Emancipation Proclamation in 1865.

Keep reading... Show less

Separate and unequal paths to business

When a bank turned down George Johnson for a business loan, he got creative. He returned and told the bank he needed $250 to take his wife on a vacation — and was approved. Then he invested the cash in his business, which became the first Black enterprise to trade on the American Stock Exchange.

Why it matters: The highways to success in the U.S. market economy — in entrepreneurship, corporate leadership and wealth creation — are often punctuated with roadblocks and winding detours for people of color.

Keep reading... Show less

Attempting to reform gig work via co-ops

Ride-hailing service The Drivers Cooperative recently debuted in New York City, claiming that its lack of VC funding would result in better driver pay and lower passenger costs.

Why it matters: TDC’s approach is a direct rebuke to the venture capital-fueled gig economy model.

Keep reading... Show less

Conservative cleric Ebrahim Raisi elected Iran's president

Hardliner Ebrahim Raisi easily won Friday's presidential election in Iran, recording 62% of the vote with more than 90% of ballots counted.

Why it matters: Currently the head of Iran's judiciary, Raisi is a close confidant of Supreme Leader Ali Khamenei and has the support of the Islamic Revolutionary Guard Corps (IRGC). His victory solidifies him as a leading candidate to succeed Khamenei, though Friday's low turnout speaks to the disillusionment of many Iranian voters.

Keep reading... Show less

Juneteenth and the country enslaved labor built on the backs of Black Americans

Juneteenth, a once-obscure commemoration of emancipation of enslaved people in Texas, has transformed into an annual reminder about how slavery robbed Black Americans of generational wealth.

Why it matters: That lack of generational wealth still denies Black families the economic security that many white families take for granted.

Keep reading... Show less



Get Goodhumans in your inbox

Most Read

More Stories