Israel’s top COVID-19 experts say that they view the Food and Drug Administration advisory panel’s decision to recommend vaccine booster shots only for Americans over the age of 65 or those in specific risk groups as a vindication of their own country’s massive inoculation campaign. Israel was the first country in the world to begin a widespread booster shot campaign this summer, and Israeli data was used during the FDA panel’s deliberations. Yet while Israel is now offering the booster shot to anyone over the age of 12, the advisory committee decided to limit it to specific high-risk populations for now. Leading experts in Israel have said over the past two days that they view the American panel’s recommendation as an acknowledgment that conditions differ between the two countries. “The FDA in principle confirmed that the third dose is safe,” said Prof. Nadav Davidovitch, director of the School of Public Health at Ben-Gurion University of the Desert, Be’er Sheva, and head of the Israeli Association of Public Health Physicians. Davidovitch added that “we need to remember the FDA did approve it for high-risk people with chronic diseases and also those at high risk because of their profession, such as health care workers of all ages. They have their own priorities and Israel has other priorities, because we started earlier. We also started with older people and then moved down and I think this is a very reasonable decision.” Israel began to offer the third dose to older citizens back in August because of rising concerns, later confirmed by new research, that the effectiveness of the existing COVID-19 vaccines began to wane after approximately six months. An Israeli study published last week showed that booster shots increase protection from infection over tenfold in those over 60, compared to those who received only a second shot of the vaccine months ago. The study used data on 1.14 million Israelis aged 60 and up who had received two doses of the vaccine by the end of August. It divided cases into two groups: one consisting of people who received two doses of the vaccine, and another consisting of people who received a third dose. The researchers found that at least 12 days after the booster shot, the rate of infection in the non-booster group was 11.4 higher than the booster group, while their rate of severe illness was 19.5 times higher. The peer-reviewed study was authored by 11 researchers, including Israel’s director of public health services, Dr. Sharon Alroy-Preis, who also spoke in front of the FDA panel and presented relevant data from Israel. Following the FDA panel’s decision, Alroy-Preis explained how Israel’s considerations differ from those of the United States. “We are three months ahead of the U.S. in the entire vaccination campaign’’, she told the Ynet news website. ‘’They don’t yet see the waning immunity [of the previous doses], but here it’s very apparent.’’ In a statement on Saturday, the Health Ministry also said that the United States is “several months behind Israel” in terms of vaccinating its citizens, many of whom are still within the window of maximum protection offered by the second dose of the vaccine. “At the point in time where Israel is at the moment, it is right for Israel to vaccinate the entire population aged 12 and older with the booster dose,” the ministry asserted. Prof. Ran Balicer, who heads a panel that advises the Israeli government on COVID policies, appeared to agree, tweeting that Israel’s health authorities also debated over several weeks whether to approve the first stage of the booster campaign, which was originally limited to those over 60. “The American decision from tonight is much broader than the one made back then in Israel,’’ he wrote. “I believe they too will gradually expand the recommendation.” In an interview with Channel 12, Dr. Ofer Levy, an Israeli member of the FDA advisory panel, concurred that Israel’s situation was different from that of the United States, where he said more data was necessary, adding that Israelis eligible for a third shot should get one, regardless of what was happening in other countries. On Saturday, the Israeli Health Ministry’s COVID dashboard reported 697 patients in serious condition, 484 of whom were not vaccinated at all. In other words, despite the fact that only 17 percent of eligible Israelis have not been vaccinated at all for COVID-19, the unvaccinated are now more than two-thirds of the country’s severe cases. Meanwhile, there were 158 serious cases of people who received two shots of the vaccine, and only 55 who had received a booster shot. Over the past week, 119 people have died of the virus, and nearly 60 percent of them were unvaccinated. The disparity is even more apparent when calculating per capita: For every death of an Israeli over 60 who received the booster shot, there are roughly 15 deaths of unvaccinated Israelis in the same age group. As of Sunday, 3,040,426 Israelis have received a booster, while 5,576,238 have received two doses and 6,062,338 have only received one. The FDA is expected to make its final decision on the third round of shots soon. It is not bound by the panel’s recommendation but will take it into consideration.
Vaccinated Israelis driving September peek in new infectios. blame the avtivaccers and the high holidays
Israel has been one of the focal points of the pandemic in 2021 owing to its rapid rollout of COVID-19 vaccines. By late February, authorities had administered at least one dose to 50% of the population, with much of Israel’s immunisation programme using Pfizer vaccines. Society then in effect reopened across the summer of 2021. However, since then Israel has reported significant outbreaks, with over 10,000 confirmed new cases being recorded each day in early September. A main part of the problem has been vaccine coverage. After its fast start, Israel’s rollout slowed. There have not been any clear interruptions to vaccine supply, so factors such as hesitancy or access to healthcare may have been an issue. For example, there’s evidence of uptake being lower among Arab and ultra-Orthodox Jewish groups. The share of the population having received one dose increased from 50% in February to only 68% in September. Children aged 12-15 have been included in the rollout since June 2021, yet despite this, currently only 62% of the population have had two doses.This has left Israel behind many other countries in terms of coverage, including the UK. Having around 30% of the Israeli population completely unvaccinated means that there’s approximately 2.7 million people who are potentially susceptible to infection and illness. There are also concerns that the immunity offered by the Pfizer vaccines may be waning over time, although much of the research on this is still at an early stage (meaning it is still awaiting review by other scientists). Israel’s hospital data is, though, showing that vaccinated people are susceptible to infection. Recent reports suggest that nearly 60% of hospitalisations are in the fully vaccinated. However, as experts have suggested, these figures don’t necessarily mean that vaccines have lost their effectiveness. The same sort of trend has been seen in the UK, and may simply reflect the fact that the elderly are more likely to be vaccinated while also being more susceptible to disease – factors which combine to inflate COVID-19 cases and deaths among the vaccinated.
A further factor is the more transmissible delta variant, which has now taken hold in Israel. This form of the virus is driving the current series of outbreaks, and its greater ability to spread may partially explain the rise in cases too.
The other big part of the problem has been Israel ending its restrictions. Dr Asher Salmon, director of the Department for International Relations at Israel’s ministry of health, suggested in July that Israel “may have lifted restrictions too early”. It’s the latest in a long line of examples showing how community transmission can be easily sustained when national policy encourages the mixing of susceptible people with no or few restrictions in place. The tragic consequences of relaxing restrictions in India shows how devastating it can be when decision-making goes awry. The COVID-19 Stringency Index created by Our World in Data is a composite measure of the strictness of the COVID-19 containment policies in each country around the world. As of August 28 2021, Israel’s restrictions score was 45.4, far less strict than New Zealand, where outbreaks continue to be limited in scope (96.3), but comparable with the UK (44.0), which is reporting around 30,000 new cases per day. Countries watched the initial vaccine rollout in Israel, gauging the vaccines’ impact and using this information to inform their own immunisation campaigns. Amid concerns about waning immunity, there are once again reasons to observe what happens next in Israel, as it is now implementing a booster programme, giving third doses of vaccines.
In terms of the effectiveness of boosters, early reports are encouraging. In those receiving a booster, the risk of a confirmed coronavirus infection appears to decrease 11-fold relative to individuals who have received two doses. However, the relevant study is still in preprint, so its findings have yet to be formally reviewed.
The use of boosters is controversial. There have been continuous calls for higher-income countries to share their vaccine stockpiles with lower-income ones. This has not yet happened to any great extent. As of early September, only 5.4% of the African continent has received at least one dose of any COVID-19 vaccine. The World Health Organization has called for a moratorium on booster shots until at least the end of September, but it seems unlikely any country will be altering their policies accordingly – including Israel. Israel’s vaccine rollout, overall, has arguably been implemented very successfully. But the country is also an example of what can happen when restrictions are relaxed too quickly. What it shows is that all countries – regardless of their current vaccine status – need to maintain longer-term plans for how to minimise the impact of COVID-19, during this current pandemic and beyond when controlling smaller outbreaks.
Nick Note: Lets keep our perspective here. This is not about politics. Its not even about who is right and who is wrong. Its about staying healthy and alive. I am seeing a lot of confusion about the record breaking infections in Israel. The data suggest that is caused by 3 things.
1. the highly infections and more deadly Delta mutation.
2, it is infecting non vaccinated people in droves.
3. To a much lesser extent we are seeing a increase in what is called breakthrough infections among the fully vaccinated as their vaccine wears off in 6 month.
For the record serious infections among the 3rd vaccinated are nill. We are seeing hospitalizations among unvaccinated at a rate 500 cases per hundred thousand. Among (2 shot) vaccinated 20 cases per 100,000. And among the fully vaccinated with the 3rd shot 1 case, one serious ill person out of 100,000. So why are cases at record highs in Israel. Well the truth is its being driven by two things… The fools unvaccinated and the lifting of ALL restrictions for the high holidays. That represent from the Jewish New Year to Succot weeks of get togethers in big groups. And the festive season is not over yet. So fasten your seat belt. The good news is we will get incredible accurate data. Early indicators will show that triple vaccinated people are not getting infected.
Stymied Bond Bears See Spark for Higher Yields in Pivotal Week
(Bloomberg) — Bond bears, long frustrated by stubbornly low Treasury yields, are girding for a make-or-break week as the Federal Reserve is expected to start laying the groundwork for reducing stimulus. The bond market enters this potentially pivotal stretch at a crossroads: 10-year yields are testing the top of their range since early July as traders anticipate that the Federal Open Market Committee will hint in its Sept. 22 decision at a plan to curb its bond buying. For the bearish contingent, which is the majority on Wall Street, this meeting represents one of the last prospective triggers this year for a decisive breakout in yields. Primary dealers surveyed by Bloomberg News predict on average that 10-year rates will be more than 30 basis points higher by year-end. Fed tapering signals are hardly the only focus. Strategists also see likely ammunition for bears in the central bank’s new forecasts for its benchmark rate. An unexpected hawkish shift in these projections in June jolted financial markets and flattened the yield curve by the most since the early days of the pandemic. “My view has been that the September FOMC will be a potential catalyst to get things moving toward higher yields by year-end,” said Blake Gwinn, a strategist at RBC Capital Markets, who expects 10-year yields to rise to 1.75% next quarter. “If that fails to materialize, I am not sure if other catalysts will get us there, and we may be stuck in range-bound trading in Q4.” The average forecast in a Bloomberg survey of primary dealers is for benchmark 10-year yields to climb to 1.69% by year-end, from a bit under 1.4% now. Deutsche Bank AG was the most bearish, forecasting 2.25%. HSBC Holdings Plc’s Steven Major, known for his persistent bullish views, had the lowest forecast, at 1%. The Fed is likely to hint Wednesday that it’s ready to taper soon with a formal announcement coming in November, according to a separate Bloomberg survey of economists. The central bank is also expected to hold rates near zero through 2022 before delivering two quarter-point increases in 2023 and three more the year after. The risk is that a hawkish shift in Fed projections known as the “dot plot” will prompt traders to recalibrate expectations for the central bank’s policy path, as happened in June. It will take just three officials to raise their dots for 2022 for a full hike to be the new median for next year, assuming everyone else keeps their forecasts where they were. Such a scenario would leave 5- and 10-year Treasuries particularly vulnerable to a selloff, according to Subadra Rajappa, head of U.S. rates strategy at Societe Generale. Expectations of such a shift have already contributed to shrinking the 5- to 30-year yield spread to the smallest since August 2020, when the Fed unveiled its new inflation framework. In options, bets emerged Friday on even higher 5-year yields. “The dots in next week’s meeting is going to be very important, not just for 2024, but also for 2022,” said Rajappa, who sees 10-year yields at 1.7% at year-end. “We believe this is an underpriced risk and bodes well for our call for higher yields.”
What to Watch
The economic calendarSept. 20: NAHB housing indexSept. 21: Building permits; current account balance; housing startsSept. 22: MBA mortgage applications; existing home sales; FOMC decisionSept. 23: Chicago Fed national activity index; jobless claims; Langer consumer comfort; Markit PMIs; leading index; Kansas City Fed manufacturing activity; household change in net worthSept. 24: New home salesThe Fed calendarSept. 22: FOMC decision and press conference by Fed Chair Jerome PowellSept. 24: Cleveland Fed’s Loretta Mester; Powell, Governor Michelle Bowman and Vice Chair Richard Clarida host Fed Listens event; Kansas City Fed’s Esther GeorgeThe auction calendar:Sept. 20: 13-, 26-week billsSept. 21: 20-year bondsSept. 22: 2-year floating-rate notesSept. 23: 4-, 8-week bills; 10-year TIPS.
Nick Note: You need to liquidate ALL your bonds. Some of you are holding US TREASURY BONDS either at treasury direct or at your broker. Interest rates have bottomed for now. We need to get ahead of this. As discussed in previous postings inflation is embedded and inflationary expectations as is the rise in inflation are at record rates. I am not referring to out beloved Zeroes Principal portion strips. i had you take profits on when they dropped below 2%. Rates on all issues will be going higher…. The fed is 400 to 500 bases points behind the power curve. So lets take profits on all your Treasury bonds and and bills of maturity over a year or more. Please note after they stamp out inflation (they will have to collapse the economy to do it. Like they have done every other time.) We will buy back out strips and bonds on the coming upward spike in rates… And then we will ride them down to double digit negative as the economy wipes out…. again.
OPEC to stick to oil production deal in October, Iraq oil minister says
BAGHDAD — OPEC and its allies will try to keep oil prices at $70 per barrel in the first quarter of 2022, Iraq’s oil minister said, adding the group is expected to stick to its current production accord when it meet in October “if prices remain stable.” Iraq total oil exports, including those of the Kurdistan region in the north of the country, should stand at an average of 3.4 million barrels per day in September, the minister, Ihsan Abdul Jabbar, told a news conference in Baghdad on Sunday.
OPEC and its allies agreed to stick to their existing plan for gradual monthly oil-production increases after a brief video conference. Ministers ratified the 400,000 barrel-a-day supply hike scheduled for October after less than an hour of talks, one of the quickest meetings in recent memory and a stark contrast to the drawn-out negotiations seen in July.
“OPEC have proven once again that they can meet and do things seamlessly,” Christyan Malek, head of oil and gas and JPMorgan Chase & Co., said on Bloomberg TV. “It’s likely that harmony is going to be utilized” to respond flexibly to any further shifts in the market over the coming year, he said.
While conditions may appear favorable for cartel right now, there are uncertainties on the horizon. Even as demand recovers, it has been buffeted by the emergence of new coronavirus variants. The question of whether Iran and the U.S. will do a deal to lift sanctions on the Islamic Republic’s oil exports — currently looking less likely — also hangs over the market. The Organization of Petroleum Exporting Countries and allies including Russia are in the process of rolling back the unprecedented output cuts implemented at the depths of the Covid-19 crisis last year. About 45% of the idle supply has already been revived, and in July the group laid out a plan for gradually returning the remainder through to September 2022. With crude prices mostly recovered from their mid-August slump and the supply outlook relatively tight for the rest of the year, the 23-nation coalition had little reason to change the established schedule of gradual monthly supply hikes, despite a request from the White House to revive output faster. There had been some doubts about the plan when oil markets wobbled over the summer as the resurgent virus threatened demand. But fuel use proved resilient, with total oil products supplied in the U.S. rising to a record in late August. “While the effects of the Covid-19 pandemic continue to cast some uncertainty, market fundamentals have strengthened and OECD stocks continue to fall as the recovery accelerates,” OPEC+ said in a statement. The group will meet again on Oct. 4. Data presented to ministers reveal a fresh challenge for Saudi Arabia and its partners in 2022. Markets were projected to tip back into surplus next year, with an average oversupply of 1.6 million barrels a day. However, the projections assume the group will restore all of the almost 6 million barrels a day of output that remains offline — an unlikely feat as many countries may struggle to reach their full targets. The amount of crude production that OPEC+ theoretically holds offline is based on questionable figures. Russia has an inflated baseline that’s significantly higher than pre-pandemic output. Some other members have outdated capacity numbers, with countries including Angola and Nigeria already struggling to make the supply increases permitted under the deal. Nick Note: Oil lives and dies on the state of the global economy visa vie the spreading Covid19 mutant strains. And how fast the FED caves in and raises rates and pulls liquidity from the system…..
UK records 164 COVID deaths, 30,144 new cases….. US hospitals buckling under delta surge: 25% of ICUs are over 95% full
The burden on US hospital ICUs has more than doubled since June.
The current surge of COVID-19 cases driven by the hypertransmissible delta variant is straining hospitals across the US, particularly in the South. Twenty-five percent of hospital intensive care units around the country are now above 95 percent full. That percentage is up from 20 percent in July and just 10 percent in June, according to data tracking by The New York Times.
The spike in critical care follows a surge in cases and hospitalizations. Average new daily cases in the country skyrocketed from around 12,000 a day in late June to 150,000 or so in mid-September. Hospitalizations have likewise risen, shooting up from an average of nearly 17,000 a day at the start of July to around 100,000 now. Though cases and hospitalizations are starting to plateau or decline slightly, they are still extremely high. Deaths, meanwhile, are increasing. In the past two weeks, deaths have increased 40 percent to the current average of nearly 1,900 per day.
Most of the cases and nearly all of the hospitalizations and deaths remain among the unvaccinated. Around 60,000 people in the US have died of COVID-19 since the start of July. With highly effective vaccines freely available, nearly all of the current deaths are preventable.
Now, along with the surge, public health experts fear strain on health care systems will lead to additional suffering and death in non-COVID patients. Hospitals in several states have been forced to ration treatments and enact crisis-care standards.
Hospitals in Alabama have exceeded 100 percent capacity of ICU beds. The Alabama Hospital Association on Tuesday reported that there were 1,592 ICU patients in the state and only 1,549 staffed ICU beds, an excess of 43 patients. The seven-day average of positive tests for the Yellowhammer State is 19 percent, suggesting that transmission is still extremely high. Alabama is one of the least-vaccinated states in the country, with only 40 percent of the population fully vaccinated. Generally, the hospitals and ICUs most overburdened are in the South, where vaccination rates are relatively low and transmission of delta has soared. In Texas, 169 out of 506 reporting hospitals have ICUs above 95 percent full, which is up from just 69 in June, the Times notes. In Florida, 24 hospitals have reported having more ICU patients than beds in the last week. In Mississippi, 94 percent of the entire state’s ICU beds are full. But the South isn’t the only place where hospitals are becoming overwhelmed. Last week, Idaho’s health department activated its crisis standards of care in 10 northern hospitals. Likewise, Alaska’s largest hospital—Providence Alaska Medical Center in Anchorage—implemented crisis standards over the weekend. The hospital announced the decision in a two-page letter sent Tuesday. “The acuity and number of patients now exceeds our resources and our ability to staff beds with skilled caregivers, like nurses and respiratory therapist,” according to the letter, which was signed by Providence Chief of Staff Dr. Kristen Solana Walkinshaw. “[W]e must prioritize scarce resources and treatments to those patients who have the potential to benefit most. We have been required to develop and enact policies and procedures to ration medical care and treatments, including dialysis and specialized ventilatory support… Due to this scarcity, we are unable to provide lifesaving care to everyone who needs it.” The letter also noted that, with the crush of COVID-19 patients, some people seeking emergency care were sitting for hours in their cars outside of the hospital, waiting to be seen by a doctor.
UK records 164 COVID deaths, 30,144 new cases
Figure brings the total UK death toll to 135,147; Russia reports 20,329 new cases in 24 hours; anti-lockdown protesters clash with police in Melbourne
- Prove your Covid status if you want to party, UK students told
- People with chronic conditions most at risk from Covid even after jabs
- Victoria police and anti-lockdown protesters in violent clashes
- Freshers’ week drive to give Covid jabs to students in England
- See all our coronavirus coverage
Elon Musk Says Starlink Will Complete Beta-Testing Phase In October
SpaceX CEO Elon Musk tweeted Friday that the company’s Starlink satellite internet network would come out of its open beta phase next month. That’s two months later than the August date Musk gave at Mobile World Congress, when he also said he expected the service to have “possibly over 500,000 users within 12 months The Starlink system calls for a constellation of nearly 12,000 satellites in low-Earth orbits that will beam continuous broadband internet service. A terminal costs $499 and there’s a $99 monthly fee for service. It opened its public beta test in October 2020, and Musk said in August that SpaceX had shipped 100,000 Starlink terminals, which includes a satellite dish and a Wi-Fi router, to users in 14 countries. As the beta ends and more countries are able to get access to Starlink, that 100,000 number is likely to grow, although it’s hard to tell when it might reach the half-million mark that Musk predicted. Starlink’s internet service is planned to be sold directly to consumers in rural areas around the world, among other customers, and it’s touting 100Mbps download and 20Mbps upload speeds. Reviews of the Starlink service so far have been mixed, however. It’s also worth noting that Musk tends to be extremely optimistic when laying out deadlines for his companies’ product releases, as Tesla customers who waited for that company’s so-called “Full Self Driving” software can attest. Nick Note: I urge you to give them a $100 deposit and get on the waiting list. This is a revolution in how internet is delivered….. Its a must for rural users and for city folk a GREAT backup system
Analysis-Investors brace for a great fall in China
Wall Street ends rollercoaster week sharply lower……. This market is in deep shit!
Pfizer and Israel study efficacy of COVID-19 vaccine wanes over time.. Get the booster shot!….
Pfizer said that data from the U.S. and Israel suggest that the efficacy of its COVID-19 vaccine wanes over time, and that a booster dose was safe and effective at warding off the virus and new variants. “Real-world data from Israel and the United States suggest that rates of breakthrough infections are rising faster in individuals who were vaccinated earlier,” Pfizer said in its presentation, which was posted on the FDA website. The drug giant is partnering with Germany’s BioNTech SE to make the shots. The decrease in effectiveness is “primarily due to waning of vaccine immune responses over time,” rather than the delta variant, Pfizer researchers said in the presentation. FDA staff also posted its report for the panel’s consideration Wednesday, summarizing much of the same data that Pfizer presented earlier. Like Pfizer,
the FDA staff found that a booster shot of the Pfizer vaccine was safe and raised antibody levels. Still, the staff said it hasn’t yet independently reviewed or verified the underlying data or conclusions of some relevant studies, such as the Israel study, which will be summarized in Friday’s meeting.
The staff’s 23-page briefing paper noted that the likely benefit of a booster shot would depend on how much the third shot reduces disease relative to the first two. If the first two shots are still highly effective, then the efficacy of the booster shot “is likely to be more limited,” the staff said. Overall data in the U.S. indicate that the first two shots of the vaccine still protect against severe disease and death, the staff said. The staff also noted that it is not currently clear whether there will be an increased risk of inflammation of the heart and heart lining after a booster shot, and that potential risks of a booster shot also must be considered. It didn’t offer a clear indication of which way the agency was leaning, which it often does before meetings. While its vaccine continues to provide strong protection against hospitalizations and severe disease in the U.S., Pfizer said in its report, the data from Israel and elsewhere suggest that a reduction in efficacy against infection may be followed by reduced effectiveness against severe disease, especially among vulnerable elderly people.Early unpublished data from an Israeli health maintenance organization suggest that a third booster dose is highly effective in areas where the delta variant is dominant, according to the Pfizer document. Giving a third dose to people more than 60 years old was associated with 86% effectiveness against testing positive for COVID starting at least a week after the booster, Pfizer said. Pfizer also detailed immune response results from a final-stage trial of booster shots in over 300 people, showing that a third dose bolstered blood antibody levels. One month after the third dose, levels of the protective antibodies were more than triple what they had been a month after the second shot. No new unexpected side effects were identified from safety data associated with boosters in the final-stage study, according to the Pfizer report. Consideration of a booster dose six months after a second dose of its shot is warranted, based on similarities between the outbreaks in Israel and the U.S., Pfizer said. Nick Note: unless your a special case I urge you to get the third dose. Talk to your medical professional, if you need more convincing get your antibodies tested. And make sure they aspirate the syringe to make SURE they are not injecting the vaccine into a vein…… So my other stories on this subject
U.S. FDA advisers recommend COVID-19 boosters for 65 and older after rejecting broad approval
(Reuters) – A panel of expert outside advisers to the U.S. Food and Drug Administration voted on Friday to recommend COVID-19 vaccine booster shots for Americans 65 and older and those at high risk of severe illness, after overwhelmingly rejecting a call for broader approval.
An influential Food and Drug Administration advisory committee on Friday rejected a proposal to distribute booster shots of Pfizer and BioNTech’s Covid-19 vaccine to the general public, paring back those plans to unanimously recommend the third shots to people age 65 and older and other vulnerable Americans.
“It’s likely beneficial, in my opinion, for the elderly, and may eventually be indicated for the general population. I just don’t think we’re there yet in terms of the data,” said Dr. Ofer Levy, a vaccine and infectious disease specialist at Boston Children’s Hospital.
The panel voted 16-2 against distributing the vaccines to Americans 16 and older, before unanimously embracing an alternate plan to give boosters to older Americans and those at a high risk of suffering from severe illness if they get the virus. That’s previously included people with diabetes, heart disease, obesity and other so-called comorbidities. The nonbinding decision by the FDA’s Vaccines and Related Biological Products Advisory Committee comes as the Biden administration has said it wants to begin offering booster shots to the general public as early as next week, pending authorization from U.S. health regulators. While the agency hasn’t always followed the advice of its committee, it often does. A final FDA decision could come in a matter of hours. The Centers of Disease Control and Prevention has scheduled a two-day meeting next week to discuss plans to distribute the third shots in the U.S. “We are not bound at FDA by your vote, just so you understand that. We can tweak this as need be,” Dr. Peter Marks, the agency’s top vaccine regulator, reminded the panel after the votes. He asked the group for suggestions on what other populations the FDA should consider for boosters, like front-line health workers and other occupations that face more exposure to Covid. The committee vote was expected to be a controversial one as some scientists, including two senior FDA officials who were involved in the meeting Friday, have said they aren’t entirely convinced every American who has received the Pfizer vaccine needs extra doses right now. White House chief medical advisor Dr. Anthony Fauci said he wasn’t surprised they didn’t recommend the shots for people 16 and older. Fauci, who has publicly backed boosters, hesitated in an interview Friday on to guess what the committee would ultimately decide. “I don’t want to get ahead of the advisory committee at the time that they’re deliberating,” he said. In a paper published days before the advisory committee meeting, a leading group of scientists said available data showed vaccine protection against severe disease persists, even as the effectiveness against mild disease wanes over time. The authors, including two high-ranking FDA officials and multiple scientists from the World Health Organization, argued Monday in the medical journal The Lancet that widely distributing booster shots to the general public is not appropriate at this time. In outlining plans last month to start distributing boosters as early as next week, Biden administration officials cited three CDC studies that showed the vaccines’ protection against Covid diminished over several months. Senior health officials said at the time they worried protection against severe disease, hospitalization and death “could” diminish in the months ahead, especially among those who are at higher risk or were inoculated during the earlier phases of the vaccination rollout. Before the vote, some committee members said they were concerned there wasn’t enough data to make a recommendation, while others argued third shots should be limited to certain groups, such as people over age 60 who are known to be at higher risk of severe disease. Some members raised concerns about the risk of myocarditis in younger people, saying more research is needed. Dr. Hayley Gans, a voting member, said she was “struck” that the FDA was asking the committee to look at the totality of the evidence presented Friday because some data, including on safety, was still insufficient. Another member, Dr. Paul Offit, said he would support boosters for people over 60, but had trouble backing third shots for younger groups due to a higher risk of myocarditis. Before the vote Friday, the committee listened to several presentations on data to support the wide distribution of booster shots, including from health authorities from Israel, where officials began inoculating the nation’s population ahead of many other countries and began offering third shots to their citizens in late July. Phil Krause, an FDA vaccine regulator and a co-author of The Lancet paper, was critical of the findings presented Friday, saying much of the data had not been reviewed by the federal agency or had not been peer-reviewed. He said the models used were complex and scientists have to ensure it “is giving you the correct results.” “That’s part of the difficulty at looking at this kind of data without having the chance for FDA to review it,” he said.
In documents made public by the FDA on Wednesday, Pfizer said an observational study in Israel showed a third dose of the Covid vaccine six months after a second shot restores protection from infection to 95%. The data was collected from July 1 through Aug. 30 when the fast-spreading delta variant was surging throughout the country.
In a presentation Friday, Dr. Sharon Elroy-Preiss of Israel’s Health Ministry argued that if officials there had not begun distributing boosters at the end of July, the nation likely would have exceeded its hospital capacity. Health officials began to see a trend, she said, of individuals in their 40s and 50s who were fully vaccinated become critically ill with Covid. “We didn’t want to wait to see those results and we knew that we needed to vaccinate a larger portion of the population in order to get the numbers down quickly,” she told the committee. Israeli health authorities expected severe cases to average 2,000 by late August, she said. “We were able to dampen that effect and our severe cases are roughly 700 or less and have stayed stable, even though we still have days at 10,000 confirmed cases.” She also said the booster shots were well tolerated by many people, citing data that showed there was only one case of myocarditis, a rare heart inflammation condition that’s been linked to mRNA vaccines, out of roughly 2.9 million people who received the extra doses. Pfizer’s booster side effects are also comparable with those that emerge after receiving the second vaccine dose, Dr. Joohee Lee, an officer at the FDA’s Office of Vaccines Research and Review, said during the meeting. Of the 289 booster recipients ages 18 to 55 monitored in Pfizer’s phase three trial, 63.8% developed fatigue, 48.4% had headaches and 39.1% experienced muscle pain. The FDA studied side effects in 2,682 recipients of Pfizer’s second Covid dose, ranging from 16 to 55 years old, reporting fatigue among 61.5% of patients, headaches among 54% and muscle pain among 39.3%. One adverse event — swelling of the lymph nodes — occurred in 5.2% of booster recipients but just 0.4% of those who received their first two doses. “The majority were mild to moderate and they did resolve,” Lee said of the lymphadenopathy cases. “Although one is reported to be ongoing at this time.” Nick Note: I think it is a travesty that the third booster shot is not being rolled out to all Americans 12 years old and up. Incredible they are still fiddle fucking around. Hello iT is an emergency situation….. HELLO!!