Pfizer says a third shot of its COVID-19 vaccine might be needed for maximum protection | ABC News


ABC News 12 July, 2021 - 08:57am 28 views

Pfizer meeting with health leaders about booster

WTVR CBS 6 12 July, 2021 - 11:01am

A Few Quick COVID Booster Updates

TPM 12 July, 2021 - 11:01am

As we noted last week, Pfizer says it plans to seek FDA approval next month for booster shots of its COVID vaccine. This is a third dose of the same vaccine many of us have already received two doses. The FDA and CDC responded quickly that for now a third dose was unnecessary. I think this was best interpreted not so much as a disagreement as a clear signal from the CDC/FDA that they will set national vaccine policy, not Pfizer.

Lurking in the background is the issue of cost.

Yesterday on Face The Nation Scott Gottlieb, former Trump era FDA commissioner who also sits on Pfizer’s board, said the country had “probably missed the window” for booster shots for the Delta variant. He said that people who got the vaccines early may already see some declining efficacy.

“If we don't get started, we’re not going to be in a position to have boosters available should we need them come fall,” @ScottGottliebMD says. “I think, quite frankly, we’ve probably missed the window for providing boosters for the Delta variant.”

— Face The Nation (@FaceTheNation) July 11, 2021

Let me note that Gottlieb was head of the FDA under Trump before the beginning of the pandemic. And notwithstanding the Trump association, he’s been a pretty credible voice on COVID throughout the pandemic. But my read of the latest studies and reports is that there is little evidence for declining efficacy at this point. (No one is more than eight months into their vaccination.) The more open question is efficacy against the Delta variant and a likely new wave, mostly among the unvaccinated this fall.

But there’s also this issue. Back in March Pfizer executive Frank A. D’Amelio was asked about the possibility of price hikes for the vaccine as the world moved from the current crisis footing into a period where COVID was endemic in the human population but largely controlled. He said Pfizer very much plans to hike the price.

From a CBS News write up …

“So if you look at how current demand and current pricing is being driven, it’s clearly not being driven by what I’ll call normal market conditions, normal market forces. It’s really been driven by kind of the pandemic state that we’ve been in and the needs of governments to really secure doses from the various vaccine suppliers,” D’Amelio explained. “So what we believe, what I believe is as we move from a pandemic state, from a pandemic situation to an endemic situation, normal market forces, normal market conditions will start to kick in. And factors like efficacy, booster ability, clinical utility will basically become very important, and we view that as, quite frankly, a significant opportunity for our vaccine from a demand perspective, from a pricing perspective, given the clinical profile of our vaccine,” he said. “So clearly, more to come here. But we think as this shifts from pandemic to endemic, we think there’s an opportunity here for us.”

When the booster story came last week a few readers flagged this to me and I did some poking around to find out more. As near as I could figure, Pfizer hasn’t returned to this since March. Presumably, such frank discussions of raising the price didn’t go over well outside of the investor press.

My point here is not to say last week’s booster announcement was a money making gambit or that Gottlieb is just shilling for his company. I’m not only not suggesting that I don’t think that. It’s more complicated. Pfizer – probably along with Moderna – has what is at this point the most effective vaccine in the world. They’re clearly pretty pumped about that and everyone associated with it is going to see current events through that prism. (I got the Pfizer vaccine; and I’m pretty pumped about it.) But Pfizer’s business interests are inseparable from these policy decisions. And for now there’s a big “may” attached to all these arguments about the need for boosters or new vaccine formulations. The US government is also clearly much more focused on getting more of the US population vaccinated in the first place than worrying about hypothetical efficacy declines over time. Added to the mix is that the US government is currently paying for all shots in the US and having set that precedent that will likely be hard to pull back from. (Not that it should: the cost of critical vaccines, as long as they can be sourced for a reasonable price, is a good thing to socialize.)

As I said, I think this minor public disagreement is mainly a matter of the US government wanting to make clear that it will make national public health policy, not Pfizer.

So keep all these factors in mind.

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Pfizer to discuss vaccine booster with US officials Monday

KPRC 2 Click2Houston 12 July, 2021 - 11:01am

Pfizer asking for approval of COVID-19 booster

FOX 4 Now 12 July, 2021 - 11:01am

Pfizer Will Make the Case for Booster Dose to Federal Regulators

Barron's 12 July, 2021 - 07:16am

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Days after Pfizer’s announcement that it would seek authorization of a booster dose of its Covid-19 vaccine drew an unusual rebuke from federal regulators, the company is set to meet with those regulators to lay out its argument, according to the Washington Post.

Citing company sources, the Post said that the company will meet with federal health officials as early as Monday. The heads of the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the National Institutes of Health, and Dr. Anthony Fauci, who leads the National institute of Allergy and Infectious Disease and is a top advisor to President Biden, have all been invited, according to the paper.

Pfizer (ticker: PFE) didn’t immediately respond to a request for comment on the reported meeting from Barron’s.

Pfizer shares were up 0.2% early Monday. The stock is up 7.6% this year.

The news of the summit comes after an unusual public dispute between the health regulators and Pfizer. Late Thursday, Pfizer and its partner BioNTech (BNTX) said they would submit data supporting authorization of a booster dose of their Covid-19 vaccine to the FDA in the coming weeks. Hours later, the CDC and the FDA pushed back with a joint statement saying that vaccinated Americans don’t need a booster shot.

“FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary,” the agencies said. “This process takes into account laboratory data, clinical trial data, and cohort data – which can include data from specific pharmaceutical companies, but does not rely on those data exclusively.”

The statement seemed a signal from the regulators that they won’t allow the Covid-19 vaccine makers to drive the scientific debate around when and if booster shots will be necessary.

Now, Pfizer appears to be seeking to mollify the agencies. On CNN on Friday, Fauci said that Pfizer’s CEO, Dr. Albert Bourla, had apologized to him for not alerting federal health officials before the company announced its intention to file for authorization for its booster shot.

“Quite frankly, the CEO, who’s a really good guy, got on the phone with me last night and apologized …for not letting us know that he was going to do it ahead of time,” Fauci said.

Pfizer, BioNTech, and their competitor Moderna (MRNA) have said for months, and continue to say, that boosters will be needed. In their joint statement on Thursday, Pfizer and BioNTech said that, “based on the totality of the data” now available, a third dose may be needed “within 6 to 12 months after full vaccination.”

Moderna CEO Stéphane Bancel  told Barron’s in June that he thinks that the booster vaccine market is even larger than he expected just a few months ago. “More than ever, we believe that coronavirus vaccines won’t provide lifelong immunity,” Bancel said.

Investors, too, are expecting substantial revenues from Covid-19 vaccine booster shots for companies like Moderna and BioNTech, at least in the near term.

Some studies, however, have suggested that the immunity provided by the initial two doses of the vaccines could last, and boosters may not be necessary, including one published in late June in the journal Nature.

Speaking in a separate CNN interview on Sunday, Fauci reiterated the joint FDA and CDC statement from Thursday. “Right now, given the data that the CDC and the FDA has, they don’t feel that we need to tell people right now you need to be boosted,” he said.

Fauci noted that research is continuing. “This isn’t something that we say, no, we don’t need a boost right now, the story’s ended forever,” he said. “There’s a lot of work going on.”

Write to Josh Nathan-Kazis at

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Pfizer to meet US officials over COVID vaccine booster

Al Jazeera English 12 July, 2021 - 06:12am

The company said it was scheduled to have the meeting with the Food and Drug Administration (FDA) and other officials on Monday, days after Pfizer asserted that booster shots would be needed within 12 months.

Pfizer’s Dr Mikael Dolsten told The Associated Press last week that early data from the company’s booster study suggests people’s antibody levels jump five to 10-fold after a third dose, compared with their second dose months earlier – evidence it believes supports the need for a booster.

On Sunday, Fauci did not rule out the possibility but said it was too soon for the government to recommend another shot. He said the Centers for Disease Control and Prevention (CDC) and the FDA did the right thing last week by pushing back against Pfizer’s assertion with their statement that they did not view booster shots as necessary “at this time”.

Fauci said clinical studies and laboratory data have yet to fully bear out the need for a booster to the current two-shot Pfizer and Moderna vaccines or the one-shot Johnson & Johnson regimen.

“Right now, given the data and the information we have, we do not need to give people a third shot,” he said. “That doesn’t mean we stop there … There are studies being done now, ongoing as we speak, about looking at the feasibility about if and when we should be boosting people.”

He said it was quite possible in the coming months “as data evolves” that the government may urge a booster based on such factors as age and underlying medical conditions.

“Certainly it is entirely conceivable, maybe likely at some time, we will need a boost,″ Fauci said.

Other leading vaccine experts questioned Pfizer’s rationale and said that more data was needed to justify a booster, especially as many countries struggle to administer the initial vaccine doses needed to protect their citizens.

“It’s disappointing that with such a complicated decision they took such a unilateral approach,” Larry Corey, a virologist at Seattle’s Fred Hutchinson Cancer Research Center who is overseeing US-government backed COVID-19 vaccine trials, told Reuters news agency.

Monday’s planned meeting between Pfizer and US health officials was first reported by The Washington Post.

Currently only about 48 percent of the US population is fully vaccinated. Some parts of the country have far lower immunisation rates, and in those places, the Delta variant is surging.

Last week, Rochelle Walensky, the CDC director, said that is leading to “two truths”: highly immunised swaths of the US are getting back to normal, while hospitalisations are rising in other places.

Fauci said it was inexplicable that some Americans are so resistant to getting a vaccine when scientific data show how effective it is in staving off COVID-19 infections and hospitalisations, and he was dismayed by efforts to block making vaccinations more accessible, such as Biden’s suggestion of door-to-door outreach.

Governor Asa Hutchinson of Arkansas agreed on Sunday that there is vaccine resistance in southern and rural states like his because “you have that more conservative approach, scepticism about government”.

Describing his efforts to boost vaccinations in his state, which is seeing rising infections, Hutchinson said “no one wants an agent knocking on a door,” but “we do want those that do not have access otherwise to make sure they know about it”.

The grassroots component of the federal vaccination campaign has been in operation since April, when supplies of shots began outpacing demand. It was outlined and funded by Congress in the $1.9 trillion COVID-19 relief bill passed in March and overwhelmingly is carried out by local officials and private-sector workers and volunteers.

Republican representative Adam Kinzinger from Illinois blasted opposition to vaccination efforts from some GOP lawmakers as “absolute insanity”. He said House Republican leader Kevin McCarthy of California and others in the party need to speak out against “these absolute clown politicians playing on your vaccine fears for their own selfish gain”.

Warning update follows an extensive review of information and discussion by CDC’s Advisory Committee.

New study to enroll thousands of children below 12 years at dozens of sites across the US, Finland, Poland and Spain.

Vaccinating younger ages is considered an important step for getting children back into schools safely.

New infections rising almost 50% across US; Pfizer, health officials at odds over vaccine booster shots: Live COVID-19 updates

USA TODAY 12 July, 2021 - 03:00am

The U.S. averaged about 19,455 new cases per day over the last seven days, a 47.5% increase from the previous week. Latest COVID-19 news.

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Pfizer is prepared to administer them, and the CDC is saying they are not needed at the moment, find out why booster shots may become necessary. USA TODAY

The U.S. averaged about 19,455 new COVID-19 cases per day over the last seven days, a 47.5% increase from the previous week, according to data from Johns Hopkins University. And 43 states saw an increase in cases last week from the week before, a sign that the pandemic is far from over in the United States.

Hospitalizations are rising again. Deaths, a lagging indicator, also appear ready to start climbing. More than 99% of deaths are now among people who have not been vaccinated, the Center for Disease Control and Prevention reports. 

Dr. Jennifer Nuzzo, with the Johns Hopkins Center for Health Security, says two-thirds of counties with sustained increases in new infections are in states with low vaccine coverage.

"But the fact that we are seeing case increases in counties even in higher vaccination states is worrisome," she tweeted. "Anywhere there are pockets of low vax coverage is at risk!"

►The chairman of the Miami-Dade county commission has tested positive for the coronavirus, about four months after he was fully vaccinated. Jose Diaz has been a frequent presence at the Surfside condo collapse site, raising questions about exposure at the site, reported the Miami Herald.

►India has already reported more than twice as many COVID-19 cases in 2021 as it had all of last year, a USA TODAY analysis of Johns Hopkins University data shows.

►The mayors of two Tokyo islands have asked the metropolitan government to take the planned Olympic torch relay off public roads amid a surge in coronavirus cases.

►Hospitalizations have continued to decrease in Wisconsin as more residents receive vaccines. The number of people hospitalized with COVID-19 has remained under 100 for more than two weeks.

📈 Today's numbers: The U.S. has had more than 33.8 million confirmed COVID-19 cases and more than 607,100 deaths, according to Johns Hopkins University data. The global totals: more than 186.9 million cases and more than 4 million deaths. Nearly 159.2 million Americans – 48% of the population – have been fully vaccinated, according to the Centers for Disease Control and Prevention.

📘 What we're reading: As many adolescents and young adults prepare to return to the classroom in the fall term amid the spread of the delta variant, the lagging vaccination rate among Generation Z is raising concerns among experts.

Representatives from Pfizer and federal health officials, who sent out conflicting signals about the need for vaccine booster shots, are planning to meet as soon as today. Last week, the American pharmaceutical giant and its partner BioNTech said they would pursue U.S. and European regulatory approval for a third dose of their COVID-19 vaccine, given the spread of variants and data they said showed diminished vaccine potency six months after the initial shots. U.S. officials, however, say they want to see the data before recommending booster shots. 

The issue is complicated by vaccine hesitancy in the U.S. – and the fact that much of the world hasn't obtained access to first shots of vaccine.

"Right now, given the data that the CDC and the FDA has, they don't feel that we need to tell people right now you need to be boosted," Dr. Anthony Fauci, a top Biden administration adviser, said Sunday on CNN in response to the news.

California will require that masks be worn at schools when classrooms open this fall, despite new guidance issued Friday from the CDC that says vaccinated teachers and students don’t need to wear face coverings inside school buildings.

Ahead of new school guidelines expected next week, health officials in California said Friday that requiring face coverings will allow all schools to reopen this fall for full in-person instruction. California Health and Human Services Secretary Dr. Mark Ghaly said that not all schools can accommodate physical distancing of at least 3 feet or more, so the best preventive measure is wearing masks indoors.

“We believe that with masking and with testing, we can get kids back to in-person 100% in our schools,” Ghaly said.

Ghaly noted the CDC guidance released Friday says that when it is not possible to maintain at least 3 feet of physical distance, “it is especially important to layer multiple other prevention strategies, such as indoor masking.”

California’s decision around schools comes as districts across the state prepare to open next month for full-time learning and the state continues to encourage residents, including kids as young as 12 years old, to get vaccinated.

For putting their health on the line during the coronavirus pandemic, prison guards in Missouri got an extra $250 per paycheck. Teachers in Georgia received $1,000 bonuses. And in Vermont, nurses, janitors, retail workers and many others got as much as $2,000.

Over the past year, about one-third of U.S. states have used federal COVID-19 relief aid to reward workers considered essential who dutifully reported to jobs during the pandemic. But who qualified for those bonuses – and how much they received – varied widely, according to an Associated Press review. While some were paid thousands of dollars, others with similar jobs elsewhere received nothing.

As society reopens, momentum to provide pandemic hazard pay appears to be fading – even though the federal government has broadened the ability of state and local governments to provide retroactive pay under a $350 billion aid package enacted by President Joe Biden in March.

So far, only a few states have committed to paying workers extra with money from the American Rescue Plan.

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