U.S. to start vast distribution of third vaccine doses subsequent month

The United States will begin distributing Covid-19 booster vaccinations on a large scale next month as new data shows vaccine protection wears off over time, US health officials said on Wednesday.

It is now “very clear” that immunity declines after the first two doses, and with the dominance of the delta variant, “we see evidence of decreased protection against mild and moderate disease,” according to the CDC. signed declaration Director Dr. Rochelle Walensky, Acting FDA Commissioner Dr. Janet Woodcock, the White House Senior Medical Advisor, Dr. Anthony Fauci, and other US health leaders.

“Based on our latest assessment, current protection against serious illness, hospitalization and death could decline in the coming months, especially for those at higher risk or who were vaccinated during the earlier stages of vaccination.”

As a result, U.S. authorities are preparing to offer booster shots to all eligible Americans starting the week of September 20, eight months after their second dose of Pfizer or Moderna vaccines, officials said. As they said recipient of Johnson & Johnson‘s single vaccination will likely need a booster vaccination, they are waiting for more dates in the next few weeks before making a formal recommendation.

“With this data, we will also keep the public informed with a timely schedule for J&J booster shots,” officials said.

In a statement late Wednesday, J&J said, “We are working with the US FDA, CDC and other health authorities and will soon be releasing new data on the Johnson & Johnson COVID-19 vaccine refresher.”

The statement added: “In July, Johnson & Johnson shared data showing that our unique COVID-19 vaccine produced strong, sustained immune activity against the rapidly spreading Delta variant and other widely distributed SARS-CoV-2 virus variants. Intermediate results from a Phase 1 / 2a study published in the New England Journal of Medicine also showed that the duration of the immune response was strong and persistent for at least eight months, as long as previously assessed. “

Ensuring long-term and permanent protection against hospitalizations and deaths is critical to containing the COVID-19 pandemic.

The plan is subject to formal recommendation by a CDC Vaccine Advisory Committee and FDA approval, also a formality.

The announcement came ahead of a Covid press conference at the White House on Wednesday, where federal health officials further outlined their plan for boosters.

The booster “will boost your immune response,” President Joe Biden said in a speech at the White House on Wednesday. “It will increase your protection against Covid-19.”

Biden also responded to criticism from some health advocates who say the US should focus on sending vaccine doses to countries with shortages rather than prioritizing booster vaccinations for Americans.

“I disagree,” said Biden. “We can take care of America and help the world at the same time.”

The decision to recommend booster vaccinations comes as the public becomes increasingly concerned about the Delta variant and an increase in breakthrough cases – infections in fully vaccinated individuals. It marks a departure from previous comments by U.S. health officials who said in recent months that fully vaccinated Americans did not need a booster at this point.

U.S. officials changed their embassy to boosters in the past few days as cases continued to rise. Fauci said Thursday that everyone is “likely” to need a booster vaccination Sometime. On Friday, federal officials approved the administration of booster shots to Americans with compromised immune systems, which include cancer and HIV patients, as well as people who have had organ transplants.

The director of the National Institutes of Health, Dr. Francis Collins, who also signed the statement, said Tuesday that new Covid data, including from Israeli health officials, caused US health leaders to rethink their position on vaccination boosters. Israel on Monday released new data showing a reduction in the effectiveness of Pfizer’s Covid vaccine against serious illness in people 65 and over who were fully vaccinated in January or February.

There are similar trends in vaccine effectiveness in the United States, Collins said. He said the surge in breakthrough cases could be due to a combination of the rapidly spreading Delta variant and the deterioration in Covid vaccine protection over time.

The effectiveness of Pfizer’s Covid vaccine is steadily decreasing over time. drops to about 84% for vaccinated people about four to six months after the second dose, according to CEO Albert Bourla. Moderna said his vaccine remained 93% effective in the first six months after the second dose, however, expect protection to wear off and need boosters.

During a news conference on Wednesday, Walensky said officials based their decision on studies showing immunity to Pfizer and Moderna vaccines decreased over several months. A study in New York from May 3 to July 25 showed that the vaccine’s effectiveness in protecting against infection decreased from around 92% to 80%. Another study by the Mayo Clinic showed that the effectiveness of Pfizer’s vaccine decreased from around 76% to 42%, while that of Moderna’s decreased from 86% to 76%.

“Right now, it’s still like our vaccine protection is working really well,” said Collins. “But we don’t want to wait until it’s oh, too late.”

The move to recommend boosters is likely to trigger criticism, especially since a large part of the world population has not even received a dose of a Covid vaccine.

Earlier this month, the World Health Organization urged rich nations to stop distributing booster vaccinations until at least the end of September to allow poorer countries to vaccinate their populations with the first rounds of vaccination. The application is part of WHO Director General Tedros Adhanom Ghebreyesus’ plan to vaccinate 40% of the world’s population by December.

The US released the statement minutes after the WHO condemned wealthy nations who support boosters for the general public.

“We clearly believe that the data so far does not suggest the need for boosters,” said Dr. Soumya Swaminathan, WHO senior scientist, during a press conference. “And we need to know which groups and at what point in time after the vaccination and which specific vaccinations the people received in their basic course.”

Lawrence Gostin, director of the WHO Collaborating Center for National and Global Health Law, called the US booster shot plan “a slap in the face” of the international health agency.

“There is a better way to create a win-win situation,” he said in a telephone interview. “We should only empower our health workers and vulnerable people. At the same time, Biden should undertake a bold campaign to vaccinate the world, including significantly increased donations and an increase in vaccine production. “

“In this way we are doing good to America and good to the world. It is in our national interest to stop the development of even more dangerous varieties,” he added.

During a briefing at the White House Tuesday, press secretary Jen Psaki said the government believes it can empower the American people while ensuring that the rest of the world is vaccinated.

“We believe this is a wrong decision. We can do both,” said Psaki. “The United States is by far the largest contributor to the global fight against Covid. We will continue to be the vaccine arsenal around the world. We also have enough supplies and had planned long enough should a refresher be required for those eligible. “Population.”

Giving third shots appears safe. Early dates from small studies of the effects of booster doses in immunocompromised patients showed no serious side effects from a third shot of an mRNA vaccine, nor did recipients develop side effects beyond those seen after the initial two-dose treatment.

Once the booster is approved, nursing home residents, health care providers and the elderly – the first groups to be vaccinated in December and January – will likely be given priority for additional vaccinations, Collins said Tuesday. He said “ideally” people should stick with the same manufacturer that they got their first two doses from.

“But if for some reason you don’t have access to it, get the other one,” he said. “Again, as a scientist, I would be more comfortable fixing our plans on real dates, and that means sticking to the same type of vaccine that you had to start with.”

– CNBC’s Rich Mendez and Robert Towey contributed to this report.