Sen. Ron Johnson sends letters to Moderna, Pfizer CEOs seeking answers about COVID-19 vaccines

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Fox News 02 July, 2021 - 10:44am 29 views

Johnson & Johnson said its one-dose shot protects against the delta variant and its immune response lasts eight months or more. Latest COVID news.

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Houston Methodist hospital system's COVID-19 vaccine mandate has resulted in over 99% compliance, but some employees are suing. USA TODAY

Concern about the highly transmissible delta COVID-19 variant and its spread among the unvaccinated continues to grow as U.S. cases rise, but positive news about vaccines' ability to fight the virus keeps coming.

Thursday, Johnson & Johnson said its one-dose shot protects against the delta variant, citing lab tests of vaccine recipients' blood. And amid concerns their shot might require a booster, the company said its immune response lasts eight months and counting.

Public health experts say the variant poses the most danger in regions where vaccinations are sparse. 

The variants “are able to find any gaps in our protection,” Dr. Hilary Babcock of Washington University at St. Louis said, pointing to how hospital beds and intensive care units in Missouri’s least-vaccinated southwestern counties suddenly are filling — mostly with adults under 40 who never received the shots.

“Any suffering or death from COVID-19 is tragic," Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said Thursday in urging more Americans to roll up their sleeves ahead of the delta variant's spread. "With vaccines available across the country, the suffering and loss we are now seeing is nearly entirely avoidable."

►Even as Californians seek a return to normal, the specter of the coronavirus pandemic lingers. New cases of COVID-19 in the state and the Bay Area have jumped more than 20% since California's June 15 reopening, according to the San Francisco Chronicle.

►Preliminary data reviewed by the CDC suggests nearly all the people who died from COVID-19 over the past six months were unvaccinated, Walensky said during a Thursday White House briefing.

►Ohio Gov. Mike DeWine vetoed a budget provision that would have refunded fines to state businesses cited for violating public health orders during the pandemic, saying that would send a "horrible" message. 

►Thailand reopened its popular resort island, Phuket, to fully vaccinated foreigners from lower-risk countries Thursday, with hopes the move will breathe new life into a tourism industry devastated by the pandemic. 

►Israel pushed back the reopening of its borders to vaccinated visitors to Aug. 1, after the country reported its highest daily infection rate in three months. 

📈Today's numbers: The U.S. has more than 33.6 million confirmed COVID-19 cases and at least 605,000 deaths, according to Johns Hopkins University data. The global totals: More than 182 million cases and more than 3.9 million deaths. More than 155.8 million Americans have been fully vaccinated – 47% of the population, according to the CDC.

📘What we're reading: Florida schools lost migrant students at a rate nearly five times higher than the non-migrant population during the 2020-2021 school year. Virtual learning, economic trials and high COVID-19 rates in farmworker communities magnified inequities for students already prone to learning loss.

Gov. Gretchen Whitmer announced the MI Shot to Win Sweepstakes Thursday, outlining a lottery-style raffle officials hope will push the state's vaccination rate above 70% for residents 16 and older.

The sweepstakes will run through Aug. 3, featuring a single drawing of $50,000 each day for 30 days, as well as a chance to win a single $1 million drawing and one $2 million drawing.

For vaccinated 12- to 17-year-olds, the sweepstakes also includes nine chances to win a four-year Michigan Education Trust (MET) Charitable Tuition Program contract valued at $55,000 each. 

Health officials working to boost lagging COVID-19 vaccination rates in Missouri are growing anxious as the Fourth of July weekend approaches, creating ripe conditions for the fast-spreading delta variant to send hospital numbers climbing.

“We are just kind of keeping an eye to see what is going to happen," said Lisa Marshall, the health director for Taney County, which includes the tourist town of Branson. “We’ve seen that these numbers can jump pretty quickly."

State officials requested aid from newly formed federal “surge response teams.” The push comes as the state's seven-day rolling average of daily new cases has risen over the past two weeks from 576.14 new cases per day on June 15 to 891.71 new cases per day on Tuesday, according to data from Johns Hopkins University.

Health officials in St. Louis County shifted their guidance Thursday, encouraging vaccinated people to wear face coverings when indoors with others whose vaccination status is unknown.

“This pandemic is not over,” said Dr. Faisal Khan, acting director of the St. Louis County Department of Public Health, told the Associated Press. “The virus and its variants present a real and imminent danger to the health of people in the St. Louis region. We must encourage vaccination and continued precautions.”

New cases of COVID-19 are on the rise compared to last week as the delta variant spreads throughout the U.S., health officials said Thursday.

The weekly average of new daily cases was 10% higher, even though cases were down 95% from the nation's peak in January, Dr. Rochelle Walensky, director of the CDC, said in a briefing.

The delta variant, is the second-most prevalent variant circulating in the U.S. and is expected to become the most common "in the coming weeks," Walensky said.

"As we prepare for Independence Day, I want to remind those who remain unvaccinated to protect themselves by wearing a mask, and avoid crowds to prevent transmission and illness," she said.

The World Health Organization said Thursday any COVID-19 vaccine it has authorized for emergency use should be recognized by countries as they open their borders to inoculated travelers.

The move could challenge Western countries to broaden their acceptance of two apparently less effective Chinese vaccines made by Sinovac and Sinopharm, which the U.N. health agency has licensed but most European and North American countries have not.

In its reviews of the two Chinese vaccines, WHO said both were found to significantly reduce the risk of hospitalizations and deaths. The two Chinese shots are “inactivated” vaccines, made with killed coronavirus, whereas the Western-made shots are made with newer technologies that instead target the “spike” protein that coats the surface of the coronavirus.

Although Western countries have largely relied on vaccines made in the U.S. and Europe, such as Pfizer and AstraZeneca, many developing countries have used the Chinese-made shots.

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Germany issues world's strongest recommendation for mixing Covid-19 vaccines

CNN 02 July, 2021 - 12:48pm

Updated 8:39 AM ET, Fri July 2, 2021

Experts push FDA to fully authorize Pfizer and Moderna COVID-19 vaccines

Yahoo News 02 July, 2021 - 12:48pm

Granting full approval, these experts argue, is a key step to address vaccine hesitancy, and to help persuade Americans to get the shots. Vaccine holdouts are potentially at great risk of contracting the Delta variant, which is quickly becoming dominant in the United States. But Americans who have received the Pfizer or Moderna vaccines are extremely unlikely to get sick from Delta or any other coronavirus variant.

Both Pfizer/BioNTech and Moderna have already submitted a Biologics License Application, or BLA, to receive the FDA’s full approval. Pfizer began the process on May 7. Moderna applied later, on June 1.

Yahoo News Medical Contributor Dr. Kavita Patel, a primary care physician in Washington, D.C., who also serves as a health policy fellow at the Brookings Institution, told Yahoo News that drug and vaccine manufacturers can expect a process like this to take usually “anywhere from three to six months,” and that it is not unusual that the agency has not yet made a decision.

However, Patel describes the pandemic as a “very high priority” and says “important stakes” are in play. “There are probably a lot of people who are waiting,” she says. Giving full approval to the vaccines “will be the sign of confidence that the vaccine is safe to take,” Patel added.

Data backs up that assertion. According to a Kaiser Family Foundation poll from May, about a third of unvaccinated people — 32 percent — said they would be more likely to get the shots if a vaccine received full approval.

All the COVID-19 vaccines have undergone rigorous safety protocols in order to be granted emergency use authorization by the FDA. And billions of people worldwide have now been vaccinated without any complications, a sure sign, in Patel’s words, that they are “incredibly safe.”

If that process is going to take longer than four or six months, Patel says, the FDA should announce why that is. Otherwise, “We need to make a case to Americans that they need to get vaccinated today, because we're seeing newer cases of the [Delta] variant in unvaccinated people almost exclusively,” she said.

So far, the FDA hasn’t offered any information related to the process or a timeline, but Patel believes agency officials are probably “being as cautious as they can,” taking time to carefully review the available data, and probably waiting for more real-world evidence to come in.

Dr. Joseph Ross, professor of medicine and public health at Yale University, told Yahoo News that since the FDA’s Center for Biologics Evaluation and Research – the division that handles the approval of the vaccines – had high standards for the emergency use authorization, this may explain why there’s no rush with the full approval process.

“They said, ‘Even though this is going to be an emergency use authorization, our standard will be high. It’s going to be nearly the same as a full approval.’ So that’s why I think the pressure is off them to have to do it more immediately, because they really required rigorous data to support the authorization on effectiveness and on safety. They’re working with the companies to collect longer-term data, and so I think it’s a matter of time,” Ross said.

Other experts have been more critical of the FDA and have said the decision is taking too long.

Dr. Eric Topol, founder-director of the Scripps Research Translational Institute in La Jolla, Calif., told U.S. News last week that these COVID-19 vaccines “should be getting full licensure now, because the FDA has already done plant inspections. They already have a humongous amount of data on safety, efficacy and effectiveness.” He added that in his view, the full approval was “overdue.”

Patel says holding back full approval of these COVID-19 vaccines is also “hard to swallow” in the context of the FDA’s recent approval of the controversial Alzheimer’s drug aducanumab. The medication, which is manufactured by Biogen, was approved under the accelerated approval pathway, despite the objections of an FDA advisory committee. Two House committees have launched an investigation into the approval and pricing of the drug.

“The drug hasn’t really had unremarkable trial data and is very expensive and not that effective, per experts in the area,” Patel said. “Compare that to the fact that we’ve got vaccines that are incredibly effective, desperately needed, and should be a no-brainer for approval.”

It’s important to underscore that the group within the FDA that handles approval of treatments such as the Alzheimer’s drug is different from the one in charge of approving the vaccines. As Ross puts it, “They're like different types of trains on different types of tracks,” so it’s not unusual that one division may have moved at a different pace from the other.

However, Patel says that the public should demand answers from the FDA and its acting commissioner, Janet Woodcock.

“We should demand some explanation — or at least some accountability — as to what they’re doing,” Patel said. “We want clarity. Where are they in the process? Why is it taking longer? Or how long will it take? Because it’s not knowing that’s really troubling the American public.”

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Virgin Galactic’s Richard Branson is aiming to beat fellow billionaire Jeff Bezos into space by nine days. The winged rocket ship will soar from New Mexico — the first carrying a full crew. Bezos, meanwhile, plans to blast into space from West Texas on July 20, the 52nd anniversary of the Apollo 11 moon landing.

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Pakistan receives 2.5 million Moderna doses from U.S

Reuters 02 July, 2021 - 12:48pm

By Umar Farooq

“These vaccines will give boost to ongoing vaccination drive in Pakistan,” Foreign Ministry Spokesperson Zahid Hafeez Chaudhri posted on Twitter. “Deeply appreciate continued support by the US in our fight against the pandemic.”

The United States donated the doses through the global COVAX facility, which aims to provide vaccines to developing countries like Pakistan. Pakistan has so far relied heavily on its ally China to provide vaccines, three of which - Sinopharm, CanSinoBio, and Sinovac - are being used in the country.

Pakistan also plans to purchase 13 million doses of Pfizer Inc’s vaccine before the end of the year, and the AstraZeneca Plc vaccine is also available in the country.

More than 13 million people have been partially vaccinated in the country, and more than 3 million fully vaccinated.

Pakistan has registered a total of 959,685 cases and 22,345 deaths. On Thursday, 1,100 new infections and 24 deaths were reported.

Reporting by Umar Farooq; editing by Jonathan Oatis

Our Standards: The Thomson Reuters Trust Principles.

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