Covid Surge Worse Than Anything We’ve Seen

German Chancellor Angela Merkel said boosting vaccination rates will not be enough to contain soaring coronavirus infections across the country, Bloomberg reported, calling for tough action as countries across Europe come down hard on the unvaccinated and prepare drastic measures to smother the outbreak.

Key Facts

Merkel reportedly told officials from her conservative party on Monday that many Germans don’t appear to understand how severe the country’s outbreak is, according to Bloomberg, calling on individual German states to implement tougher restrictions this week.

The measures would exceed new restrictions barring unvaccinated people from public transport and many areas of public life—which apply in areas where hospitalized Covid-19 patients exceed a certain threshold—and health minister Jens Spahn said he could not rule out another nationwide lockdown.

Some politicians in Germany are debating following neighboring Austria—which went back into full lockdown Monday after a more targeted, unvaccinated-only lockdown—in requiring everyone to get vaccinated against Covid-19.

From February next year, Austrians refusing the jab will face fines of up to €3,600 ($4,000), with smaller penalties for those refusing booster shots.

Czechia and Slovakia have also started to make life harder for vaccine holdouts—Slovak Prime Minister Eduard Heger reportedly called the measures a “lockdown for the unvaccinated”—barring them from using various services, entering restaurants and public events.

Crucial Quote

By spring, “pretty much everyone in Germany… will be vaccinated, cured or dead,” Spahn said at a news conference Monday. “With the very contagious delta variant, it is very, very likely … that anyone who is not vaccinated will over the next few months become infected.”

Key Background

Europe has, again, become the center of the pandemic. Cases and deaths have been rising there even as they mostly fell around the world. The World Health Organization said it is “very worried” about the situation, warning that an additional 500,000 deaths could be recorded by March if sufficient steps aren’t taken.

Many countries, particularly in Central and Eastern Europe, are facing dramatic surges and infections are at record-breaking levels. Slovakia, Slovenia, Austria, Czechia, Germany and the Netherlands are all at, or have hit, new highs and cases are rapidly rising in other countries.

Violent protests against new lockdowns and other restrictions have erupted across the bloc as governments scramble to contain rising cases. Many of these measures explicitly target the unvaccinated, who experts and officials warn are undoubtedly driving the new wave by refusing provably safe and effective vaccines.

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I am a London-based reporter for Forbes covering breaking news. Previously, I have worked as a reporter for a specialist legal publication covering big data and as a freelance journalist and policy analyst covering science, tech and health. I have a master’s degree in Biological Natural Sciences and a master’s degree in the History and Philosophy of Science from the University of Cambridge. Follow me on Twitter @theroberthart or email me at rhart@forbes.com

Source: Covid Surge ‘Worse Than Anything We’ve Seen’: Germany Mulls Tough Restrictions As Europe Targets Unvaccinated With Lockdown, Compulsory Shots

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Further Reading

Czechs, Slovaks target unvaccinated people in step behind Austria (Reuters)

Not Just Austria—Here Are The Countries Making Covid-19 Vaccination Compulsory For Everyone (Forbes)

Europe’s Carrot vs. Stick Approach to COVID-19 Vaccination (Atlantic)

Austria Sends Unvaccinated Into Lockdown—Here’s How Other Nations Are Limiting People Who Don’t Get Covid-19 Shots (Forbes)

Merkel Says Covid Spike ‘Worse Than Anything We’ve Seen’ (Bloomberg)

‘We Have To Face Reality’: Austria Announces Nationwide Vaccine Mandate, Full-Scale Covid-19 Lockdown (Forbes)

Lockdown And Restrictions Resurface In Europe As Continent Battles Another Covid Surge (Forbes)

FDA Committee Says It’s Safe For All Adults Who Got J&J’s COVID-19 Vaccine To Get a Booster

The Food and Drug Administration should authorize a second “booster” dose of Johnson & Johnson’s JNJ, +0.74% COVID-19 vaccine for adults who were initially vaccinated with this vaccine, according to a group of scientists and clinicians that advises the regulator.

The FDA’s Vaccines and Related Biological Products Advisory Committee voted 19-0 that allowing adults who were initially vaccinated with the J&J shot to get a booster is safe and effective. Their recommendation is based on giving a booster to those 18 years old and older at least two months after they got their first shot.

“This does look more like a two-dose vaccine,” Dr. Michael Nelson, a professor of medicine UVA Health and the UVA School of Medicine and a temporary voting member of the FDA committee.

One difference with this booster recommendation is that the group of people who would qualify for the J&J booster can get it two months after getting their first dose, compared with six months after the primary series of shots for the mRNA vaccines developed by Moderna Inc. MRNA, -2.31% and BioNTech SE BNTX, -1.06% /Pfizer Inc. PFE, -0.43%.

If the FDA follows the advice of the committee, which it is not required to do but often does, it means that all three COVID-19 vaccines that are available in the U.S. have authorized boosters, with the caveat that there are restrictions in place on who can get a mRNA booster.

The mRNA boosters are reserved at this time for people older than 65 years old, adults who are at high risk of severe disease, and those who face higher exposure to the virus because of their jobs.

About 15 million people in the U.S. have received the J&J’s adenovirus-based COVID-19 vaccine. J&J’s stock is up 2.6% so far this year, while the broader S&P 500 SPX, +0.75% has gained 18.1%.

By: Jaimy Lee

Jaimy Lee is a health-care reporter for MarketWatch. She is based in New York.

Source: FDA committee says it’s safe for all adults who got J&J’s COVID-19 vaccine to get a booster – MarketWatch

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Critics:

The Janssen COVID‑19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized by FDA through an Emergency Use Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019 (COVID‑19) in individuals 18 years of age and older.

The emergency use of this product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the medical product under Section 564(b)(1) of the FD&C Act, unless the declaration is terminated or authorization revoked sooner.

Healthcare professionals should be alert to the signs and symptoms of thrombosis with thrombocytopenia in individuals who receive the Janssen COVID-19 Vaccine. In individuals with suspected thrombosis with thrombocytopenia following administration of the Janssen COVID-19 Vaccine, the use of heparin may be harmful and alternative treatments may be needed.

Consultation with hematology specialists is strongly recommended. The American Society of Hematology has published considerations relevant to the diagnosis and treatment of thrombosis with thrombocytopenia following administration of the Janssen COVID-19 Vaccine (https://www.hematology.org/covid-19/vaccine-induced-immune-thrombotic-thrombocytopenia).

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Some Vaccinated Travelers Are Already Getting Covid-19 Booster Shots But Experts Say That May Be Counterproductive

Since January, all travelers must test negative for Covid-19 within 72 hours of entering the U.S. There are many reports in recent months of both vaccinated and unvaccinated travelers testing positive within the last three days of their trip.

This can completely upend re-entry plans because a positive test result means delaying a return to the U.S.. Travelers must get retested until they receive a negative test result and, in the meantime, they must remain in their destination at their own expense, often under quarantine or isolation orders.

To give themselves an extra insurance policy against becoming a breakthrough case, some fully vaccinated American travelers are finagling a third shot of the vaccine a few weeks before leaving on their trip — even though the U.S. Food and Drug Administration (FDA) has yet to give booster shots an official green light. In some cases, they are simply presenting themselves as unvaccinated at pharmacies or other vaccine providers in order to get another dose. Others are getting a booster with the blessing of their doctors.

“People are acting in their own self-interest, and that doesn’t shock me,” said Dr. Kavita Patel, a primary care physician in Washington, D.C., who served as an advisor on health policy in the Obama administration.

“It’s unfortunate, because there remains no evidence that if you’re under 65 years old and otherwise healthy, that you need a third shot right now,” said Dr. Vin Gupta, a pulmonary critical-care physician and an affiliate assistant professor at the Institute for Health Metrics and Evaluation (IHME) at the University of Washington. “There needs to be guardrails here. We need to understand what three doses mean. Are we protected for five years or just another eight months? There are lots of open questions.”

The Biden administration has urged the FDA to release a booster rollout plan as soon as possible, given that some Americans, including first responders and immunocompromised people, received their initial doses in 2020 and officials want the most vulnerable people to be at the front of the line for boosters.

The FDA is currently evaluating when a wider swath of vaccinated Americans should begin receiving Covid-19 booster shots, which is likely to be either six or eight months after completing their initial doses. “The administration recently announced a plan to prepare for additional Covid-19 vaccine doses, or ‘boosters,’ this fall, and a key part of that plan is FDA completing an independent evaluation and determination of the safety and effectiveness of these additional vaccine doses,” said the agency in a statement.

Pending FDA approval, booster doses might begin rolling out to eligible Americans as early as this month, said U.S. Surgeon General Dr. Vivek Murthy on a call yesterday that was hosted by the U.S. Health and Human Services Covid-19 Community Corps.

It’s important for individuals to adhere to the FDA’s recommended timing of a third shot, said Dr. Patel. Just as with any other three-shot vaccine series, the intervals between shots will be gauged to give people robust immunity for a longer period of time.

“That’s actually consistent with what we do with other vaccines. Think of the timing of any pediatric vaccine or the human papillomavirus vaccine,” said Dr. Patel. “What I tell patients is that there’s actually a downside from getting a booster too early. They could be potentially harming themselves six to 12 months down the line. I mean, Covid is not going away.”

While Dr. Patel thinks “it’s inevitable” that everyone will eventually need another shot, “there’s unfortunately a perception that in order to go on a trip and avoid getting sick or avoid potential additional costs, people think that a booster is going to be what they need to do to stay protected. I think a lot of people are just thinking, ‘Well, if two is better than one and three is better than two, at some point, I’ll get four.’ And that’s a very dangerous assumption.”

In other words, instead of rushing to get a third shot before a planned trip, it makes more sense to stick to the optimal timing for a booster shot, then plan future trips accordingly.

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I watch trends in travel. Prior to working at Forbes, I was a longtime freelancer who contributed hundreds of articles to Conde Nast Traveler, CNN Travel, Travel + Leisure, Afar, Reader’s Digest, TripSavvy, Parade, NBCNews.com and scores of other outlets. Follow me on Instagram (@suzannekelleher) and Flipboard (@SRKelleher).

Source: Some Vaccinated Travelers Are Already Getting Covid-19 Booster Shots—But Experts Say That May Be Counterproductive

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U.S. Set To Recommend Booster Covid-19 Vaccine Dose For Most People, Reports Say

U.S health officials are expected to recommend Covid-19 vaccine booster doses for Americans across all eligible age groups eight months after they received their second vaccine dose, to ensure lasting protection against the coronavirus as the more infectious delta variant spreads across the country partially blunting the efficacy of existing vaccine regimens.

According to the Associated Press, health officials could announce the booster recommendation as soon as this week, just a few days after an additional vaccine dose was recommended for people with weakened immune systems.

The Biden administration could then begin rolling out the third shots as early as mid-to-late September, the New York Times reported, citing unnamed officials.

The first booster shots will likely be administered to nursing home residents, health care workers and elderly Americans who were among the first people in the country to be inoculated.

The Associated Press notes that the formal deployment of the booster doses can only take place after the vaccines have been fully approved by the Food and Drug Administration—an action that is expected for the Pfizer jab in the next few weeks.

The Food and Drug Administration is expected to fully approve the Pfizer vaccine in the coming weeks which will formally open the door for it to be offered as a booster to millions of Americans who have already received two vaccine doses.

Big Number

59.4%. That’s the percentage of the eligible U.S. popuplation (12 years of age and older) that has been fully vaccinated against Covid-19, with 70% receiving at least one dose, according to the CDC’s tracker.

Surprising Fact

An estimated 1.1 million people have already received an unauthorized booster dose of the Moderna or Pfizer vaccine, ABC News reported last week, citing an internal CDC document reviewed by the broadcaster. The number is likely an undercount as it only accounts for people who received a third dose of an mRNA vaccine but does not count those who may have received a dose of the one-shot Johnson & Johnson vaccine and then received a second dose of either the Moderna or Pfizer vaccines.

Key Background

Last week, the U.S. Food and Drug Administration approved a booster dose of the Covid-19 vaccines made by Pfizer and Moderna for people with compromised immune systems. The targeted move was aimed at providing better protection for people who have undergone solid organ transplants or those diagnosed with conditions that are considered to be immunocompromised.

Unlike the eight-month gap being proposed for booster doses for the general population, immunocompromised patients can receive their third dose as early as 28 days after their second shot. The FDA’s decision followed similar moves undertaken by Israel, France and Germany who began administering an additional dose to vulnerable populations amid the threat of the more infectious delta variant of the virus.

Contra

As the more infectious delta variant of the coronavirus takes hold across the U.S. questions about the effectiveness or even the necessity of a booster dose remain unanswered. While some vaccines are slightly less effective against the variant, it is still unclear if protection against more severe disease and hospitalizations have been impacted significantly as well.

This makes any decision to authorize booster doses remains a controversial one in the global context as critics decry the fact that developed nations are administering an additional dose at a time when several poorer nations have limited access to vaccines. Earlier this month, the World Health Organization (WHO) called for a moratorium on Covid-19 vaccine booster shots until at least the end of September.

Further Reading

U.S. to Advise Boosters for Most Americans 8 Months After Vaccination (New York Times)

US to recommend COVID vaccine boosters at 8 months (Associated Press)

More Than 1 Million Have Received Unauthorized Third Dose (WebMD)

FDA Authorizes Extra Covid-19 Vaccine Dose For Those With Weakened Immune Systems (Forbes)

How Good Are Covid-19 Vaccines At Protecting Against The Delta Variant? (Forbes)

I am a Breaking News Reporter at Forbes, with a focus on covering important tech policy and business news. Graduated from Columbia University with an MA in Business and Economics Journalism in 2019. Worked as a journalist in New Delhi, India from 2014 to 2018. Have a news tip? DMs are open on Twitter @SiladityaRay or drop me an email at siladitya@protonmail.com.

Source: U.S. Set To Recommend Booster Covid-19 Vaccine Dose For Most People, Reports Say

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