現代ビジネス。
奇妙な治験結果。
つい先日、米国のファイザーに続いてモデルナも欧米の規制当局に新型コロナ・ワクチンの緊急使用許可を申請した。英国政府は今月2日、ファイザー製ワクチンの使用を承認するなど、同ワクチンの実用化が目前に迫っている。
が、一方で製薬会社が成果を出し急ぐあまり、若干気になる動きも見受けられる。
https://www.nytimes.com/2020/11/25/business/coronavirus-vaccine-astrazeneca-oxford.html 。
上記NYT記事によれば、英国のオックスフォード大学と製薬会社アストラゼネカが共同開発した新型コロナ・ワクチンの臨床試験(治験)には、誤りや一連の不規則性が見られることから、その信頼性に疑問が投げかけられているという。
先月23日、アストラゼネカは英国とブラジルで実施した臨床試験(フェーズ3)の暫定的な分析結果を公表した。それによればワクチンは最高で90パーセント、最低で62パーセント、平均で70パーセントの(感染に対する)予防効果が見られたという。
ただ、この治験結果が発表されると、多くの科学者や報道関係者らがより詳細なデータの公表を求めた。と言うのも、治験で90パーセントの予防効果が報告された被験者グループは、全部で2回に分けて接種されるワクチンの1回目で、本来、投与されるべき量の半分しか接種されていなかったからだ。
一方、2回とも本来の量のワクチンを接種された被験者グループの場合、それによる予防効果は62パーセントだった。
これらの結果から当然湧き上がってくる疑問は、
1)なぜ、片方のグループには(1回目のワクチン接種で)本来の量の半分しか投与(接種)されなかったのか?
2)なぜ、少ない量のワクチンを投与された被験者グループの方が、より高い予防効果を示したのか?
の2点だ。
臨床試験でセレンディピティ。
まず1)の理由について、アストラゼネカのワクチン開発責任者は、それが治験段階における誤りであることを認めた。
ワクチンの製造過程において一部の分量測定に差違が生じ、それを知らずに治験を行った科学者が、一部のグループには半分の量を本来の量と勘違いして接種してしまったのだという。
また2)に関しては、未だ確かな答えは得られていない。
ただ、結果的にワクチン量が本来の半分の方が予防効果が高いことが発見されたわけだが、これについて同責任者は「セレンディピティ(偶然・幸運による発見)」と位置付けた上で、「(被験者の)誰も危害を被らなかった。……それが故意に見つかったにせよ、偶然見つかったにせよ、どちらでも構わないではないか」と述べたという。
しかし、こうした主張に対しては厳しい批判が聞かれる。確かに基礎研究の段階であれば、セレンディピティのおかげで画期的な科学的成果が生まれたり、新たな薬剤候補となる化学物質が発見されることはよくある。しかし、臨床試験の最終段階に入って「偶然の過ちから、より効果的な投薬法が見つかりました」と言われても、それを評価する方は困ってしまうだろう。
また、1回目に半分の量を投与された被験者の数は約2800人と、それ以外の被験者(2回とも本来の量を接種された被験者)の約8900人に比べて非常に少ないこと、そして年齢層が55歳以下に絞られていること等が問題視されている。
つまり被験者の数がかなり不均等であることに加えて、2800人のグループがより高齢の被験者を含んでいないこと等から、治験の分析結果や解釈に疑問符がつけられたのだ。
「1回目に本来の半分の量を接種されたこと」より、むしろ「単に比較的若い年齢層であったことが、より高い予防効果を示した真の理由ではないのか」という見方も成立するわけだ。
期待が高かっただけに…。
今回の臨床試験の恐らく最大の問題は、透明性が欠けていたことだ。
アストラゼネカは最初に治験結果を公表した際、それが故意ではなく偶然の過ちから得られた結果であることに言及しなかった。さらに、被験者グループの人数や年齢など詳細なデータはほとんど明らかにしなかったという。
周辺の科学者やメディアの記者たちから質され、仕方なく過ちを認めてデータを公開したというのが真相のようだ。
今回の結果報告に対し、WHO(世界保健機関)は「より少ない量の方が予防効果が高いという仮説を立証するには、さらなる臨床試験が必要になるだろう」との見解を発表した。
以上のような批判や提言を受け、同社は追加の臨床試験を実施する意向を明らかにしている。
アストラゼネカのワクチンは1回分の推定価格が数ドルと、(同じく20~35ドルの)ファイザーやモデルナ製のワクチンよりも安く、家庭用冷蔵庫とほぼ同じ温度で保管できることから、途上国を中心に高い期待を集めてきた。
日本政府も1億2000万回(6000万人)分の供給を受ける契約を同社と結んでいる。ただ、今回の若干功を焦ったかに見える臨床試験の結果を受け、追加試験の実施などから供給開始までにはまだまだ時間がかかりそうだ。
が、それ以上に、新型コロナ・ワクチンへの信頼感を損ねたことは大きい。
どの国にも、安全性への懸念等からワクチンへの拒絶反応を示す人が一定の割合で存在する。しかし、止まるところを知らない感染拡大を収束させるには、ワクチンの実用化と普及を待つしかないだろう。それを促すためにも、製薬会社にはより慎重で厳格な姿勢が求められている。
CNET。
現在、Moderna、Pfizer、AstraZenecaなどの製薬会社が新型コロナウイルス感染症(COVID-19)の感染を予防するワクチンの開発に取り組んでいる。だが、これらのワクチンは遺伝的に黒人やアジア人の系統の人に投与しても、白人と比べて十分な免疫が得られない可能性があるとする研究論文を、マサチューセッツ工科大学(MIT)が米国時間12月2日に公開した。
この論文の著者の1人、David K. Gifford氏は、MITが発表したプレスリリースで、「もちろん、他にも考えるべき因子は数多くあるが、われわれの暫定的な結果によると、黒人とアジア人の系統の人はワクチンが効かないリスクが平均して少しだけ高くなるおそれがあることが示された」と述べている。Gifford氏はMITのコンピューター科学・人工知能研究所(CSAIL)に所属する研究者だ。
この論文は「Predicted Cellular Immunity Population Coverage Gaps for SARS-CoV-2 Subunit Vaccines and their Augmentation by Compact Peptide Sets」(SARS-CoV-2サブユニットワクチンにおける細胞性免疫の人口カバー率の差の予測およびコンパクトなペプチドセットによるその拡大)と題されている。プレプリントサーバーのbioRxivで公開されており、まだ査読を受けていない。そのため、この論文に掲載されている知見の取り扱いについては特に注意しなければならない。
Moderna、Pfizer、AstraZenecaのものを含め、このウイルスのワクチンの多くが、同じ弱点を持っていると、MITの論文は指摘する。その弱点とは、ワクチン開発に使われるウイルス粒子セットの多様性が不十分で、さまざまな遺伝子構成を持つすべての人から同レベルの免疫反応を引き出すことができないという点だ。
この研究はコンピューターモデルをもとにしている。Gifford氏、さらに論文の共著者のGe LiuとBrandon Carterの両氏(2人ともCSAILの博士課程に所属)は、患者データと免疫系内のタンパク質のモデルに基づき、民族分類や遺伝子上系統(被験者の自己申告による)に基づくさまざまな集団について、ワクチンが「ヒット」する(つまり免疫反応の促進に成功する)可能性を、機械学習モデルを使って予測した。
菅義偉のゴーツー事業は、人災に成りつつある。医療崩壊が起きつつある大阪は外出自粛要請が出される。コロナ禍の現在、政府が遣るべき仕事は「感染症対策」「コロナ災害生活困窮者の救助」の二つがある。オリンピックは、どちらか。
菅義偉のゴーツー事業への前のめりの姿勢を見ると。来年6月までゴーツー事業で経済活動を回し、オリンピックでもう一儲け。ワクチンは予約しているから、国民はワクチン接種迄、自己責任で感染するな。田舎者根性の老害の頑固者という人格が透けて見える。
ワクチンの安全性は信頼出来るのか。オックスフォード大学・アストラゼネカのワクチンでさえ、杜撰な代物である。杜撰な第三相臨床実験をしながら、免責事項「健康被害出たら、副作用訴訟が起きたら」ワクチン購入国が費用負担する。信頼出来ない。
ワクチンの効果はどうか。日本人・アジア人は「ファクターX」を保有している。欧米・インド・ブラジル。アジア・オセアニアでは、死亡者の数が桁違いである。ファクターXは「交差免疫の獲得」であるとの説がある。既に、交差免疫を獲得している日本人にイギリス・アメリカで誕生したワクチンを接種するのは、逆に副反応・副作用を誘発するのではないか。
パンデミックを終息させるには世界中の77憶人に、ワクチンが行き渡る必要がある。ワクチンを、大量生産する費用が必要である。WHOの「コバックスイニシアティブ」に先進国が参加する必要がある。ロシア・中国・アメリカが参加しないのは、ワクチンビジネスの為である。
ワクチンを接種することへの健康不安・抵抗を、どう納得させるのか。ファイザー・ビオンティックワクチンはマイナス80度に冷凍する必要がある。電気の無い国・地域にどうやって搬送するのか。サハラ以南のアフリカでは電力供給された医療施設は、わずか28%にすぎない。ワクチンを接種する医療者の人材育成の問題もある。接種するのに高度な技術が必要なワクチンもある。診療所への道のり、発展途上国ではワクチン接種の診療所迄、8時間かかる国もある。低所得の貧しい国の人々が、徒歩・自転車・船で診療所迄、移動出来るのか。
アメリカ・ロシア・中国、ワクチンビジネスを狙う国家。イギリス・日本の様にワクチンを買い占める国家が、パンデミックの収束を遅らせる。
IOCバッハは、「IOCが多大な費用を払って五輪参加者・訪問者にワクチンを接種して貰う」と説く。日本人とオリンピックアスリートだけが、優先的にワクチン接種して、「平和の祭典の開催」と「胸を、張れるか」。
オリンピックは「アマチュアリズム」「非商売主義」「スポーツマンシップ」を奪われ、電通・パソナが儲かる利権商売に堕している。
東京五輪招致の為、8億9000万円の賄賂・裏金が使われ。セネガルの世界陸連前会長・ラミンディアクへの、竹田恒和の2億3000万円収賄はフランス検察に捜査されている。森喜朗が会長を務める非営利団体に招致委員会から1億4000万円支払われている。森喜朗は「私は非営利団体の財政処理には直接関与していない」。と「桜を見る会前夜祭」への政治資金規正法・公職選挙法違反で地検に取り調べられる安倍晋三と「同じセリフ」を答えている。
オリンピックが中止になった場合、東京オリパラ準備局の試算ではマイナス29兆円・みずほフィナンシャルの試算ではマイナス7兆円の経済損失が出る。
NHKがスポンサー企業54社に「延期された大会で期待したメリットが得られるか」質問すると65%の35社が、「分からない」と回答。「得られない」と答えた企業は9%に当たる5社。得られない理由は「広告・プロモーション機会の減少。新型コロナの感染拡大を懸念する国内世論。」である。
「世紀の祭典」の華やかなCMは、もう無理なのである。来年には「五輪の為にワクチンを独占している」という世界からの非難が寄せられる。
無理だらけのオリンピックに開催の意義は無い。「スポーツマンシップ」公正・公平、参加することに意義がある。オリンピックの精神に立ち戻り、ワクチンが行き渡らない世界で、日本だけ「平和の祭典」「世紀の祭典」東京オリンピックを開催している場合ではない、との正気を取り戻す必要がある。
菅義偉。オリンピックの強行など来年の抱負を抱くな。先ずは、感染症対策である。「検査・隔離・治療」の基本。医療現場への財政出動。医療現場の人材不足の解消。無症状患者・軽症患者の為の宿泊治療施設の準備。
漫画家・お笑い・学者・元厚労省医務技官に「経済を回さねば自殺者が出る」と「人命を人質にした」デマを拡散させるな。コロナ被害で生活困窮に陥った被害者を「失業給付」「救済給付金」「家賃免除」「公共料金免除」「住民税・保険料の減額」手厚く保護しろ。生活保障の拡充・セーフティネットの再構築を早急に実現させ、自殺させるな。
出来ることは山ほどある。
東スポウェブ。
本当に開催できるのか。来年夏に延期した東京五輪へ向けた政府、東京都、大会組織委員会による新型コロナウイルス感染症対策調整会議が2日に開かれ、海外選手の出入国の仕組みやアスリート検査態勢など多岐にわたる対策の中間整理が報告された。組織委は相変わらず開催へ前向きだが、国内でも重症者が増加しており心配は尽きない。問題山積のコロナ対策について、専門家はどう見るのか。
今回の中間報告ではアスリート、大会関係者、観客の入国、輸送、会場などについてコロナ対策の議論が整理された。各国の選手には出国前に陰性証明を取得することを求め、選手村滞在中は4~5日に1回の間隔で定期検査を受けることなどが盛り込まれた。ただ、本番までの大きな課題となるのが「検査」と「ワクチン」の問題だ。
先月、都内で開催された体操国際大会では内村航平(31=リンガーハット)の「偽陽性」が話題となった。一度は陽性と判定され、その後の再検査で偽陽性と判明。無事に開催に至った経緯がある。だが、五輪の参加選手は約1万人だ。果たして同じような措置は取れるのか?
実際に内村の検査にあたった東京明日佳病院の熊本久大院長(44)は「五輪で今回と同じ態勢を取るのは非常に難しいと思います」と話す。
前述の大会は体操競技限定で参加選手は30人。日本への入国前から選手を隔離するなど、徹底した対策が施された。熊本院長は「今回は管理された“密閉空間”に入っているのに陽性になった。だから偽陽性ではないか?との動きが取れましたが、1万人以上の選手がいる五輪で、いっぺんに陽性者が出ると対応は難しいでしょう」と指摘する。
また、ワクチンの問題もある。中間報告はワクチンがないことを前提にしている一方で、国際オリンピック委員会(IOC)のトーマス・バッハ会長(66)は「選手村に入る全ての関係者にワクチン接種を奨励する」と明言。
熊本院長は「五輪のことだけを考えればそうでしょうが、その供給量などを踏まえた場合、五輪ありきで考えるのは医療従事者としておかしいと言わざるを得ない。順番は間違えてはいけません。命に勝るものはありません」と警鐘を鳴らした。
さらに「僕は五輪開催自体には賛成ですが(対策で)まだ抜け落ちていることはたくさんある」とした上で「大会期間を分散するとか、無観客にして密を避けるとか、やり方次第ではできると思います」と話した。いずれにせよ、現状では多くの課題が残されたまま。果たして、五輪本番までに不安を払拭することができるのか。
JBプレス。
とにかく「開催ありき」一辺倒だ。2021年夏に延期された東京五輪・パラリンピックに向け、政府と東京都、大会組織委員会は2日、首相官邸で「新型コロナウイルス感染症対策調整会議」を開いた。
外国人観客の入国対策では2週間の待機を求めず、専用アプリの使用で健康管理を図る方針が中間整理としてまとめられ、来年春までに決定することになった。この専用アプリは陰性証明書やビザ情報、現在国内で使用されている接触確認アプリ「COCOA」の機能も反映され、来年6月をめどに完成するという。
ただ、この東京五輪で訪日する外国人観客には国内の医療関係者や有識者から強い要望も出されていたもののワクチン接種は義務付けない方向性だ。
入国する参加選手や関係者も14日間の待機は免除される。その一方で選手村では日本人選手や大会関係者を含め、96~120時間(4~5日)の間隔で定期検査を実施。事前キャンプ地やホストタウン滞在中も検査を徹底させるという。
大会開催に向けて選手の健康管理を担う「感染症対策センター」(仮称)や「発熱外来」が常設化されることも盛り込まれ、これら中間整理でまとめられた事項はすべて来春までに正式に決まる見込みだ。
■ 水際対策の簡素化もやむを得ず?
このニュースは特に問題提起もなくサラッと多くのメディアで報じられているが、何とも同意し難い。特に明確な医学的根拠も示されていないにもかかわらず、要は東京五輪に関連する外国からの入国者については2週間の隔離期間を設けないまま入国を認め、専用アプリや検査徹底等で感染拡大と予防につなげられると一方的に決めつけているのである。
恐ろしい話だ。普通に考えても、これだけ世界がコロナ第3波にさいなまれている中で入国の際の水際対策を簡素化させてしまっていいわけがない。「東京五輪」という免罪符を基にすれば、何でも許されると思ったら大間違いだろう。
それとも政府や東京都、それに大会組織委員会の面々は来年夏の大会開催前には現在期待が高まっているワクチン開発が成就し、今よりもコロナショックは終息に向かっているとの確証を持っているのだろうか。そうだとしたら、余りにも楽観的過ぎると言わざるを得ない。
この流れを作り出す裏側には無論、観客を入れた形での五輪開催に決意を示している菅義偉首相の強い意向もある。実際に中間報告では「(入国後の)14日間隔離・公共交通機関不使用を条件とすることは観戦を事実上困難にする」と外国から入国した観客への対応について注釈が明記されており、菅首相のリーダーシップの下で目指す「有観客五輪」を何としてでも実現させるためには通常の水際対策の簡素化もやむを得ないと暗に結論付けられている格好だ。
■ 「2週間の待機」に代わる対策が「専用アプリ」と「定期検査」。
急ピッチで物事が進められていることに不信感を募らせ始めている“身内”も少なくない。大会組織委員会に属する関係者の1人は「もう少しまともなアイデアが練られているのかと思いきや、いざフタを開けてみたら中間整理で示された内容は非常に陳腐で正直驚きました」と本音を吐露。次のようにも続けた。 「五輪という世界的イベントなのであらゆる英知が注がれ、コロナ対策は万全に近い形になっていなければいけない。ところが、入国者に義務付けられている14日間の隔離を排除してわざわざハードルを下げているだけで、それに代わる方策が専用アプリと定期検査ぐらいなんて今のシステムとほとんど変わらず目新しさはない。
確かにIATA(国際航空運送協会)も自分たちの業界にとって死活問題にかかわることから2週間隔離を簡素化するための専用アプリ開発を進めており、来年6月の完成が見込まれる日本の専用アプリはおそらくそのIATAと技術協力を図りながら同協会のアプリ機能を参考にするか、ある程度の共有がなされることにはなるでしょう。ただ、外国人観客にワクチン接種を入国時の条件としない点に関しては、いくら認可が未だ下りていないとはいえ、随分と早く方向性を固めてしまっているのだなという印象。明らかにすべてが突貫工事で進められているとしか思えず非常に不安です。このままでは国民の多くの方々から理解を得られるのは難しいでしょう」。
参加アスリートたちに対する不安も拭えない。入国時に隔離撤廃となった外国人選手が大勢集まる選手村での長期滞在はいくら定期検査が義務付けられるといっても、常に「もしかすると時間が経ったら症状が現れる選手も中には出てくるのではないか」という心配がつきまとう。前出の関係者は、このようにも補足する。
「参加選手や大会関係者の立場から考えてもいくらソーシャルディスタンスが呼び掛けられようが、選手村は間違いなく他の国や地域からの代表選手がひしめきあって“カオス”のようになります。いろいろな考え方の選手や関係者が世界中から集まるわけですから、統制が取れるかどうかは甚だ疑問。その中でクラスターが発生してしまったら目も当てられない事態となります。
実際のところ、まだまだ解決しなければならない難問が山積している。実は複数の国々の国内五輪委員会から組織レベルで東京五輪のコロナ対策について『万全とは言い難いのではないか』『透明性に欠ける』などといった懐疑的な声が向けられており、いずれも納得を得られていない。我々日本側も明確な回答ができずに事実上の保留状態になっている案件があるのです。
下手をすれば、こうした国々は新型コロナ対策での安全性が確認できないとして東京五輪への参加を断念、つまりボイコットに踏み切る可能性も捨てきれません」。
■ 追加費用3000億円の負担割合をめぐり組織委、東京都、国が丁々発止 。 先月末、多くの主要メディアによって大会延期に伴う追加費用が約2000億円に上る見込みであることが一斉に報じられた。大会関係者の話を総合すると、コロナ対策費用も約1000億円になるとみられており、これにより合計3000億円もの追加費用が必要になる見通しだ。
これらの背景も「大会関係者サイドから主要朝刊紙、大手民放局にこれら情報がリークされた。その狙いは当初、今年3月に試算した追加費用よりも約1000億円の削減に成功したことを強調させ、国民の理解を得られると踏んでいたが、結局コロナ対策費用が同額程度かかってしまうことで“相殺”され、かえって反発を強める結果となってしまっている」(事情通)というから、まさにお粗末極まりない。
今月末で契約が切れる大会スポンサーもコロナ禍の影響で減額、あるいは難色を示す企業が大多数を占めているようだ。しかも3000億円の分配の割合を巡って大会組織委員会、東京都、政府は丁々発止となっている。いずれにせよ血税に頼るしかなく、そのツケを払わせられるのは都民、そして国民全体だ。
アスリートを取材する立場として“平時”なら東京五輪は夢の舞台として期待に胸を膨らませたいところだ。しかしながら国民の声に耳を傾けず、感染リスクにも目をつぶり、印象操作を仕掛けてまで強行されても世の中から歓迎されるはずがないだろう。「開催ありきなど“狂気の沙汰”」という以外に適切な言葉が見当たらない。
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