President Biden said last week that he expected a fully approved vaccine in early fall. But the F.D.A.’s unofficial deadline is Labor Day or sooner, according to multiple people familiar with the plan. The agency said in a statement that its leaders recognized that approval might inspire more public confidence and had “taken an all-hands-on-deck approach” to the work.

Federal regulators have been under growing public pressure to fully approve Pfizer’s vaccine ever since the company filed its application on May 7. “I just have not sensed a sense of urgency from the F.D.A. on full approval,” Dr. Ashish K. Jha, the dean of the Brown University School of Public Health, said in an interview on Tuesday. “And I find it baffling, given where we are as a country in terms of infections, hospitalizations and deaths.”

Although 192 million Americans — 58 percent of the total population and 70 percent of the nation’s adults — have received at least one vaccine shot, many remain vulnerable to the ultracontagious, dominant Delta variant. The country is averaging nearly 86,000 new infections a day, an increase of 142 percent in just two weeks, according to a New York Times database.

Full approval of the Pfizer vaccine will kick off a patchwork of vaccination mandates across the country. Like most other employees of federal agencies, civilians working for the Defense Department must be vaccinated or face regular testing. But the military has held off on ordering shots for 1.3 million active-duty service members until the F.D.A. acts.

The City of San Francisco has said its roughly 44,500 employees must be fully vaccinated within 10 weeks of F.D.A. approval. The State University of New York, with roughly 400,000 students, is on a parallel track.

A number of health care systems have issued similar mandates to employees, including Beaumont Health, the largest health provider in Michigan, with 33,000 employees, and Mass General Brigham in Massachusetts, with about 80,000 workers.

In a guest essay in The Times last month, Dr. Peter Marks, the agency’s top vaccine regulator, wrote that undue haste “would undermine the F.D.A.’s statutory responsibilities, affect public trust in the agency and do little to help combat vaccine hesitancy.”

The regulators want to see real-world data on how the vaccine has been working since they authorized it for emergency use in December. That means verifying the company’s data on vaccine efficacy and immune responses, reviewing how efficacy or immunity might decline over time, examining new infections in participants in continuing clinical trials, reviewing adverse reactions to vaccinations and inspecting manufacturing plants.

At the same time, senior health officials at the F.D.A. and other agencies are grappling with whether at least some people who are already vaccinated need booster shots. Several officials are arguing that boosters will be widely needed before long, while others contend that the scientific basis for them remains far from settled.

Aug 4 (Reuters) - The World Health Organization is calling for a halt on COVID-19 vaccine boosters until at least the end of September, its head Tedros Adhanom Ghebreyesus said on Wednesday, as the gap between vaccinations in wealthy and poor countries widens.

The call for a moratorium is the strongest statement yet from the UN agency at a time when countries deliberate the need for boosters to combat the fast-spreading Delta variant of the coronavirus.

"I understand the concern of all governments to protect their people from the Delta variant. But we cannot accept countries that have already used most of the global supply of vaccines using even more of it," Tedros added.

"We need an urgent reversal from the majority of vaccines going to high-income countries to the majority going to low-income countries," Tedros said.

DIRECTOR OF ISRAELI PUBLIC HEALTH SERVICES DR. SHARON ALROY-PREIS:

So there are two major concerns. One is that the Delta variant is 50% more infectious than the previous, the Alpha variant, which was 50% more infectious than the original one. And we still have a third of our population that is not immunized or has not been recovered. We have a large children population. And so that is obviously concerning. The other point is that we are seeing about 50% of the people who are infected right now are vaccinated, fully vaccinated individuals. And so that is obviously of concern. Previously, we thought that vaccinated, fully vaccinated individuals are protected. We're now see- we now see that the vaccine effectiveness against disease is roughly 40%. It still remains high for severe disease. But we are seeing diminished protection, especially for people who have been vaccinated earlier.

DR. ALROY-PREIS: Exactly, exactly. There is a spread among household contacts, but if we take household contacts out of the equation, the- the- the risk of a confirmed case who is vaccinated to infect others is about 10% for- to infect one other individual and lower than 10% to infect more than one.

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As of May 1, 2021, CDC transitioned from monitoring all reported vaccine breakthrough cases to focus on identifying and investigating only hospitalized or fatal cases due to any cause. This shift will help maximize the quality of the data collected on cases of greatest clinical and public health importance.

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