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「稀なワクチン被害の犠牲者が米政府が支払うかどうかを待つ」 (Bloomberg 2021/5/3)
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* 18歳のエマ・バーキーはジョンソン&ジョンソン（J&J）のコロナウイルス・ワクチンを接種後、
けいれんと脳血栓を起こし昏睡状態になった。
* 彼女は徐々に回復し、病院からリハビリ・センターに転院。第1回目の医療請求額が
51万3千ドルになり、支援のため友人たちがネットで募金を始めた。
* 彼女の家族は明らかにワクチンによって引き起こされた被害だと信じているが、
ワクチンメーカー、政府にはまだ連絡はしていない。
* ワクチン・メーカーと医療保険会社は健康被害に関して免責されているので責任は問われない。
* その代わり政府が補償をすることになっているが、今までの例では多くのワクチン被害が
否定され、補償が認められることは難しい。
* PREP法に基づく補償プログラム(Countermeasures Injury Compensation Program)により、
保険でカバーされない医療費や賃金が支払われることになっているが、4月26日の時点で、
445件のワクチンないし医療による被害が提出されている。
* CDCはワクチンは、承認前に厳密に検査されており、ワクチンによる死者は
まだ確認されていないとしている。
* 810万人以上がJ&J製ワクチンを接種し、彼女を含め稀な血栓が生じた例が17件ある。
政府はワクチンは安全で効果的であるが、ワクチン接種と血栓症の関係は調査中という。
* J&Jは重篤な副反応を調査中。プライバシー保護のため個々の例については議論しないと
している。副反応は米国食品医薬品局（FDA）に報告されており、患者は自分の経験を
広く分かち合うことが、ワクチンの安全性を高める上で重要だと述べる。
* 保健資源事業局（HRSA)によると、445件のうち、COVIDに関するものは4分の1で、
半分以上は、人工呼吸器、回復期血漿療法、ヒドロキシクロロキンなど治療が原因であった。
* 死亡した50例は十分な治療がなされなかったためだが、ワクチン・メーカー等は免責されており、
故意の過失の場合だけが法廷で争われることになる。
* 人工呼吸器などによる死亡のほか、接種後のいろいろな健康問題、胸痛、顔のけいれん、麻痺、
足首の骨折などがあるが、これらの原因がワクチンや医療が原因であるという明確な
科学的エビデンスを研究者が得るのには時間がかかる。
* 被害者は必要とされる医療記録を提出しておらず、COVIDに関し補償が実際に支払いが
なされたことはないとHRSAは言う。
* この補償プログラムはワクチン被害には必ずしも適しているとは言えないと批評家は言う。
施行して10年で、500件のうちたった39件が補償され、その大半はH1N1ワクチンの被害で、
実際に支払われたのは29件で600万ドルだった。
* 代わりに10年以上の実績のあるワクチン被害補償プログラム（通称、ワクチン裁判所）を
適用すべきだという。これはインフルエンザ・ワクチンを接種した子供や妊婦が対象である。
* ワクチン被害救済者弁護士会によると、ワクチンによる健康被害かどうか問い合せが
殺到している。
* HRSAは、COVID-19のケースはワクチン裁判所の基準を満たしていないと言う。
* ワクチンは免疫システムが疾患と闘うように開発されているが、まれに重篤なアレルギー反応や
麻痺を引き起こすことがある。
* 1980年代には、いくつかのメーカーが訴訟に反発してワクチン市場から撤退すると脅した。
それで議会は研究被害を補償し、ワクチン裁判所を創設した。
* トランプ政権では訴えの多い重篤な肩の障害や失神を補償から除外するとしたが、
バイデン政権はそれを取り消し、議会は調査する専門家の数を2倍にすることを検討中。
* そうなると、ワクチンと関係ないケースもワクチン裁判所に持ち込まれる恐れもある。
* 副反応と治療に関連があるか科学的に証明するのは難しい。
* ワクチン裁判所では、ワクチンの副反応リストがあり、これらに当てはまる被害は、
科学的な証明なしに補償を得ることができる。
* エマは子供のための仕事をしており、建設会社でパートをしていて、
ハイリスク・グループではなかったが、コロナウイルスのワクチンを接種することにした。
* 彼女は1週間後に気分が悪くなり、頭痛と吐き気があった。
両親は彼女の目を見て、とんでもないことが起きていることに感づいた。
* 彼女が救急車で担ぎ込まれた南ネバタの病院の医師は、彼女の反応は、
他のJ&Jワクチンによる被害と似ていると判断した。
* その後、彼女はカリフォルニア州サン・ベルナンディノの病院にヘリで移送された。
* 彼女の家族は保険で大半の治療費がカバーされると期待している。
政治家がすでに彼女のケースに関して動き出している。
* おそらく、治療費は100万ドルを越すだろう。
彼女の保険会社は、長期リハビリの費用を支払うことには同意している。
彼女がファンドで集めたのは4万8千ドルにすぎない。
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ワクチン・メーカーが健康被害に関して全面的に免責されているのが間違いです。
彼らは空前の利益を上げています。
こういった重篤な被害は稀だというのなら、全額補償しても痛くもかゆくもないはずです。
日本では二ケタほど医療費は安いですが、やはりワクチン接種による健康被害が
必ず問題になるでしょう。
日本政府は健康被害を補償すると言っていますが、HPVワクチンの例を見ればわかるように、
まともに補償する気など全くありません。
御用医学者を動員して「気のせい」にされて終わり、被害者は泣き寝入りです。
これからワクチンを接種する人は、エマのような悲劇が起きうることをよく知っておくべきでしょう。
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「Victims of Rare Vaccine Injury Wait to See If U.S. Will Pay」
(Bloomberg 2021/5/3)
https://www.msn.com/en-us/news/us/victims-of-rare-vaccine-injury-wait-to-see-if-us-fund-will-pay/ar-BB1giOXK
(Bloomberg) -- High school senior Emma Burkey received her “one and done” Johnson & Johnson coronavirus vaccine on March 20, and within two weeks was in an induced coma following seizures and clotting in her brain.
She’s making a slow recovery, having recently been transfered from the hospital to a rehabilitation center, and the first round of bills totaled $513,000. The 18-year-old’s family friends in the Las Vegas area started a GoFundMe account to help with medical expenses from the very rare vaccine reaction.
“We don’t know what’s going to happen with Emma, how long it will it take for her to return to a normal life,” said Bret Johnson, the family’s minister, who’s acting as spokesman for the Burkeys. He said the family believes her condition is linked to the vaccine but hasn’t yet been contacted by the company or U.S. health regulators, and that a connection hasn’t been independently confirmed.
Burkey’s family can’t look to J&J to cover the medical costs not picked up by her insurance because a 2005 law -- extended last year to include the Covid-19 pandemic -- shields manufacturers and health-care providers from state and federal liability in instances of public health and bioterrorism emergencies. In exchange for immunity for vaccine makers, the federal government pledged compensation for adverse reactions to coronavirus treatments and vaccines, but it’s a program with a history of rejecting claims and a relatively high bar for recovering costs.
The Countermeasures Injury Compensation Program, run by an obscure office within the U.S. Health and Human Services Department, covers medical costs and lost wages not paid by insurance. Some 445 claims had been filed as of April 26 for adverse reactions to either vaccines or treatments, according to the Health Resources and Services Administration, which runs the program.
Related: J&J Vaccine Liability Shield a Boon Despite Rare Blood Clots
The Centers for Disease Control and Prevention said in a statement that the vaccines were “rigorously studied” before approval, and are “rigorously monitored now that they are being used by the public.” Of more than 240 million vaccines from three manufacturers that have been administered in the U.S., the CDC said there are currently no confirmed vaccine-related deaths, and that reports of allergic reactions are in line with those from vaccines for other conditions.
More than 8.1 million people have received the J&J shot and so far 17 -- including Burkey, her pastor said -- reported a rare type of blood clotting. Burkey’s case was one considered by health officials during a pause in distribution of the J&J shot, Johnson said. U.S. regulators said the vaccine is safe and effective, and continue to investigate whether there’s a link between the shot and the rare blood-clot syndrome.
One-shot doses of the Johnson & Johnson Covid-19 vaccine are prepared at a clinic in Los Angeles on March 25.
Photographer: Mario Tama/Getty Images
J&J said it will “carefully review reports of adverse events in individuals receiving our medicines or vaccines,” but will not discuss individual cases out of privacy concerns. Adverse reactions are reported to the Food and Drug Administration and “we encourage patients to share their experiences as this information is critical in maintaining a high standard of product safety,” the company said.
Only about a quarter of the 445 Covid-related reactions reported to the countermeasure program so far are from vaccines, while more than half were from various treatments, according to HRSA. Those treatments include ventilators, convalescent plasma, and hydroxychloroquine -- the anti-malarial drug touted by former President Donald Trump that was found to have greater risks than benefits in treating coronavirus.
‘Willful Negligence’
There were 50 deaths from alleged failure to provide sufficient care, according to the claims. Those types of claims would normally result in civil lawsuits, but under the law shielding vaccine makers and health-care workers, suits can only proceed if there’s “willful negligence,” a high bar in U.S. courts.
The compensation applications also include reports of death following ventilator use and other treatments, and a wide range of health issues after vaccination, including chest pain, facial spasms, paralysis, and even injuries like broken ankles. It will take time for researchers to determine if there’s “compelling” scientific evidence to link those injuries to the vaccines or treatments.
There have been no payouts so far in Covid cases, which the HRSA says is because it hasn’t received all the information needed. Required medical records still haven’t been received from the applicant in the first claim, which was filed in September over an adverse reaction to convalescent plasma, the agency said.
Critics say the countermeasures program isn’t the best way to handle the vaccine claims. The program has existed for a decade and, as of April 1, only found 39 of almost 500 claims eligible for compensation -- mostly for reactions to the H1N1 vaccine -- and paid out only about $6 million in 29 cases.
Instead, they say, compensation requests should go through a decades-old program within the same agency called the Vaccine Injury Compensation Program, also known as the “vaccine court.” It has a dedicated source of funding -- an excise tax on every vaccine administered in the U.S. -- but is limited to those shots routinely recommended for children and pregnant women, and those for the seasonal flu.
Anne Carri n Toale of Maglio Christopher & Toale in Sarasota, Florida, former president of the Vaccine Injured Petitioner’s Bar Association, said her office is “overwhelmed” with calls from people trying to figure out if various medical conditions are caused by the vaccines and if there’s any recourse.
“With the Covid vaccine in particular, a higher percentage of calls are reassurance-seeking and ‘I have questions’ than with a normal vaccine,” Toale said. She’s hoping Congress will move the Covid vaccine cases to the vaccine court, where there’s a greater chance of a payout and it also pays for “pain and suffering” and covers legal fees and expert witnesses.
An HRSA spokesman said that in order for Covid vaccine injuries to be covered by the vaccine court, they’d have to be CDC recommended for routine administration to children or pregnant women. “No Covid-19 vaccine currently meets these criteria,” the spokesman said in an email.
Liability Lawsuits
The U.S. government’s vaccine compensation program has its roots in the rise in lawsuits. Vaccines are designed to trigger the immune system into fighting off diseases. In rare instances, they can cause the system to go into hyperdrive, resulting in severe allergic reactions and even paralysis.
In the 1980s some manufacturers were threatening to pull out of the market because of lawsuits, so Congress decided that the social benefit to promote vaccination also meant an obligation to cover adverse reactions, and created the vaccine court.
A Trump-era regulation to exclude compensation for severe shoulder injuries and fainting -- which make up the bulk of claims -- was rescinded by the Biden administration, and Congress is considering doubling the number of special masters who hear cases.
If that happens, all of the countermeasures cases should be moved to the vaccine court, including ones not involving vaccines, said Peter Meyers, former director of George Washington University Law School’s Vaccine Injury Clinic.
Related: Biden’s HHS Rescinds Trump-Era Vaccine Injury Payment Rule
“It can be a difficult scientific question,” Meyers said, referring to whether there’s a link between an adverse reaction and a treatment. “We’re never going to have, like the standard in criminal court, proof beyond a reasonable doubt. It can be a complicated question but it’s a doable question.”
The vaccine court has a list of adverse reactions known to sometimes be caused by a vaccine, making it easier for an application to get compensation without proving a direct link. It also has a lower burden of proof, requiring only that the vaccine was more likely than not to be the cause.
Emma Burkey, who works with children and has a part-time gig at a construction company, decided to get the coronavirus vaccine even though she wasn’t in a high-risk group.
About a week later she started to feel unwell, and 10 days after having the shot went to bed with a headache, and vomited. Her parents, Russ and Kathy Burkey, helped her to the bathroom, where “her face locked up, and head twisted,” Johnson, the family minister, said. “They could see in her eyes that something was very, very wrong.”
An ambulance took Burkey to the local southern Nevada hospital, where doctors realized her reactions were similar to others reported from the J&J shot. Emma was airlifted to a neural treatment unit at Loma Linda Hospital in San Bernardino, California.
The family is counting on most costs to be covered by insurance. They learned of the compensation program during a call from U.S. Senator Catherine Cortez Masto’s office. The Nevada Democrat’s staff have also contacted HHS and will monitor Burkey’s case “to ensure the family gets the support they deserve.”
If the first bill to the Burkeys is any indication, the cost of Emma’s medical care may run into the millions of dollars. Her insurance provider has already agreed to cover the long-term rehab she’ll need, Johnson said in an update on the GoFundMe page, which has raised about $48,000 so far.
“Right now it feels like the national debt,” Johnson said. “It’s so big you can’t get your head around it.”
(Updates with J&J comment in eighth paragraph.)
For more articles like this, please visit us at bloomberg.com
2021 Bloomberg L.P.
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