FDA approves updated KP.2 vaccines from Pfizer, Moderna | Real Time Headlines

The U.S. Food and Drug Administration Thursday officially recognized Updated on COVID-19 vaccine Pfizer and modern,Will New footage is on the way Reaching most Americans in the next few days summer peak Viral.

The vaccines target a strain called KP.2, a descendant of the highly contagious omicron subvariant JN.1 that began circulating widely in the United States earlier this year. KP.2 was the dominant Covid strain in May but now accounts for only about 3% As of Saturday, there were 11,000 cases in the U.S., according to the latest data from the Centers for Disease Control and Prevention.

Still, Pfizer and Moderna say their KP.2 vaccine can generate stronger immune responses than those against other circulating subvariants of JN.1 last year, such as KP.3 and LB.1. omicron strain XBB.1.5 able.

“Given the continued waning of immunity due to prior exposure to the virus and prior vaccination, we strongly encourage those who are eligible to consider receiving newer COVID-19 vaccines that offer greater protection against currently circulating variants. ,” Director Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

In June, the Centers for Disease Control and Prevention respected This year, everyone over 6 months old will get the updated COVID-19 and flu vaccines. Pfizer and Moderna’s new vaccine is specifically approved for people ages 12 and older, with emergency use authorization for children 6 months to 11 years old.

Pfizer said in a statement that it will begin shipping its new vaccine immediately and expects it to be available in pharmacies, hospitals and clinics across the United States “in the coming days.” Moderna also expects its lens to launch in a similar time frame, according to a statement.

“Timely vaccination against COVID-19 remains one of the best ways to protect people and prevent severe disease,” Moderna CEO Stephane Bancel said in a statement. “We appreciate the FDA’s timely review and encourage Individuals should contact their health care provider about getting the updated COVID-19 vaccine along with their flu shot this fall.”

The FDA approval comes weeks ahead of last year’s shot, the agency Clear September 11th.

The early arrival of newer vaccines may provide some relief to Americans as the virus numbers in the U.S. have been relatively high this summer. “High” or “very high” coronavirus concentrations reported in wastewater in nearly every state CDC data. As other forms of testing decline, wastewater monitoring gives us a sense of how widespread the virus is in the United States.

Other indicators of the virus are rising but remain well below levels at the peak of the epidemic. Tested positive for coronavirus According to the CDC, the unemployment rate rose to 18.3% in the week ended August 10, up from 17.9% the previous week.

Meanwhile, the Centers for Disease Control and Prevention says about 4 per 100,000 people are hospitalized with COVID-19 in a given region. That’s up from about 1 per 100,000 people hospitalized for COVID-19 in May, the lowest level since the pandemic began.

The summer coronavirus wave is likely to wane when the vaccine reaches patients’ arms and triggers an immune response against the virus, which typically takes two weeks after vaccination.

Still, federal health officials have long told Americans to expect COVID-19 vaccines to be updated every year as the virus creates new strains that can evade immunity from previous vaccinations or infections — Protection decreases over time. This is similar to how the U.S. rolls out a new flu vaccine every year.

It’s unclear how many Americans will actually roll up their sleeves and try again in the coming months.

According to statistics, only about 22.5% of U.S. adults received the latest round of vaccinations launched last fall CDC data to early May.

Many Americans who received previous rounds of COVID-19 vaccinations said they were not getting the latest booster shots because they lacked concerns about the virus, according to a report in November. Survey by health policy research institute KFF. Others said they were too busy to get the shot, the survey showed.

In June, the FDA asked vaccine manufacturers to produce a vaccine for JN.1, then told them to change the target to KP.2 “if feasible.”

This change seems to make NovavaxIn the same month, the company applied for authorization of the new JN.1 lens, but was at a disadvantage. The FDA has not yet approved the biotech’s vaccine.

Novavax said in a statement that it is working “productively” with the FDA as it completes its review. Novavax expects its vaccine to be authorized in time for peak U.S. vaccination season

The company noted that its vaccine provides protection against descendants of JN.1, including KP.2.3, KP.3, KP.3.1.1 and LB.1.

Novavax makes a protein-based vaccine that cannot be quickly updated to target another strain of the virus. Protein-based technology is a decades-old method used for routine vaccination against hepatitis B and shingles.

Meanwhile, vaccines from Pfizer and Moderna use messenger RNA technology, which teaches cells how to make proteins that trigger an immune response against the coronavirus. mRNA vaccines are easier to develop and update than protein vaccines.