Why is vaccine distribution proving so difficult?

Johns Hopkins Bloomberg School of Public Health’s Dr. Eric Toner describes why the distribution of COVID-19 vaccines is seeing so many speed bumps when the flu vaccine is distributed so smoothly

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    Reuters/Lucy NicholsonFederal health officials predict the rollout of Johnson & Johnson’s coronavirus vaccine may be resumed within “days” but restrictions on certain age groups may be considered.The Food and Drug Administration called for a pause on the vaccine’s rollout on Tuesday after six blood-clot cases were reported among the 7 million people who have been given the shot. That makes the reported complications beyond infrequent: less than one in a million. Nevertheless, the federal government will immediately stop using the vaccine at all federally-run vaccination sites across the nation. State health officials have been advised to follow suit and not use the J&J shots they have in storage. New York was the first state to confirm it was immediately pausing its rollout but said all appointments scheduled for Tuesday can go ahead with the Pfizer shot. In a Tuesday statement, the FDA said it made the decision after six reported cases of what it called “rare and severe type of blood clot in individuals after receiving the vaccine,” but it stressed: “Right now, these adverse events appear to be extremely rare.” Today FDA and @CDCgov issued a statement regarding the Johnson & Johnson #COVID19 vaccine. We are recommending a pause in the use of this vaccine out of an abundance of caution.— U.S. FDA (@US_FDA) April 13, 2021 In a joint media call on Tuesday between the FDA and the Centers for Disease Control and Prevention, acting FDA commissioner Dr. Janet Woodcock said she expected the pause to last “a few days.” The aim, officials said, is largely to give time for regulators to reach out to clinicians so they know how to diagnose and report similar cases.Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, emphasized that the pause is a recommendation, not a mandate. “If an individual healthcare provider has a conversation with an individual patient... we aren’t going to stop that provider from administering the vaccine,” he said. However, in a White House press conference later on Tuesday, U.S. National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci was unwilling to ratify Woodcock’s prediction, stating that it was “too premature” to even say whether the J&J vaccine would be allowed to be used after the pause.Some seven million Americans have received J&J’s vaccine to date, and around nine million more have been shipped out, according to data from the CDC. The shots make up a key part of the Biden administration’s vaccine rollout because they only require a single dose and are easier to store than others.However, health officials said that the pause is unlikely to have a significant impact on U.S. vaccine distribution. CDC Principal Deputy Director Dr. Anne Schuchat noted that J&J has been supplying a “great minority” of vaccine doses. Health officials told The New York Times that the six U.S. recipients developed a rare disorder involving blood clots within about two weeks of their shots. All of them were women between the ages of 18 and 48. One is reported to have died and another remains in serious condition in a hospital.The FDA and CDC are now expected to examine any possible link between the vaccine and the disorder, and decide whether—and how—to continue the J&J rollout.Fauci said that the FDA and CDC are looking into potentially excluding certain age groups. “It is entirely conceivable... that there may be some restrictions in age group,” he said. This mirrors the approach taken by a number of European countries with the AstraZeneca vaccine. Some European countries, like France and Italy, have imposed or are considering imposing age limits on who can receive it. Schuchat acknowledged that the pause could be concerning news for those that have already received the J&J vaccine. “People who got the vaccine within the last couple of weeks” should monitor for symptoms like “severe headaches, abdominal pain, leg pain, and shortness of breath,” she said. Individuals experiencing these symptoms should contact their medical provider. However, those that received the vaccine a month ago were at very low risk, Schuchat added. Johnson & Johnson said in a statement that there’s no evidence to confirm its vaccine caused the very rare blood-clot cases. “We are aware that thromboembolic events including those with thrombocytopenia have been reported with COVID-19 vaccines,” the company reportedly said. “At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine.”The announcement follows a similar setback in Europe, where the AstraZeneca vaccine was paused to investigate its possible link to blood-clot events. After studying 86 European cases, the European Medicines Agency decided that the benefits of the vaccine outweighed the risk, even with the possibility that blood clots are an extremely rare side-effect.Marks said on Tuesday that the potential J&J side effects closely resemble similar blood-clotting incidents reportedly associated with the AstraZeneca vaccine, calling the parallel “plainly obvious.” However, health officials stressed that these events are extremely rare and that the pause was being recommended out of an “abundance of caution.”When asked during Tuesday’s press conference if the pause would worsen U.S. vaccine hesitancy, White House Coronavirus Response Coordinator Jeff Zients acknowledged the issue. “Hesitancy is a challenge,” he said. The solution, he suggested, could be in “community-level” outreach. “People trust their local doctor, their faith leader.”Read more at The Daily Beast.Get our top stories in your inbox every day. 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  • Tory MP claims GCHQ told him his Gmail account was safer than parliamentary email after he was targeted by hackers

    A senior Tory MP has said he was told by sources at GCHQ that his personal Gmail account was safer than using his Parliamentary email after being repeatedly targeted by suspected Chinese hackers. Tom Tugendhat, the chairman of the Commons foreign affairs committee, said the warning showed the need for both ministers and Parliament to take a more robust stance against Beijing’s attacks of British democracy. The MP, who has previously revealed efforts by Chinese cyber hackers to access his accounts and impersonate him online, is one of seven Parliamentarians who have been sanctioned by China for calling out its actions in Hong Kong and against the Uighur minority in Xinjiang. Mr Tugendhat revealed on Tuesday that the latest attack occurred last week, when emails, purportedly from him, were circulated which claimed he had resigned as chairman of the committee. He believes he is the victim of Chinese “psyops” - psychological operations - which have occurred on several occasions in recent years in apparent attempt to discredit him professionally. Calling on ministers and the Parliamentary authorities to take a tougher stance on Beijing’s attempts to silence critics, he told BBC Radio 4’s Today programme: “I was told by friends at GCHQ - not formally, I admit - that I was better off sticking to Gmail rather than using the parliamentary system because it was more secure. "Frankly, that tells you the level of security and the priority we are giving to democracy in the United Kingdom. What the British Government and Parliament has to respond to is defending freedom of speech in the UK.” Addressing Mr Tugdenhat’s concerns, Sir Lindsay Hoyle, the Commons Speaker, told MPs: “It is in the public interest that members should be able to speak... fiercely in raising issues of concern. “This includes the chair of the foreign affairs select committee. People are democratically elected representatives and nothing should interfere in the democratic process.” Separately, Parliamentary officials insisted the Westminster email system offered significantly greater protection than external providers, and the National Cyber Security Centre (NCSC) said MPs should continue to rely on it. A parliamentary spokesman said: "We have robust cybersecurity measures in place and work closely with partners in the National Cyber Security Centre. "In line with guidance from the NCSC we would always encourage MPs to use parliamentary emails, which offers significantly higher levels of security than external providers." It came as Nigel Adams, the foreign minister with responsibility for China, told MPs that the Government "stands in complete solidarity with those sanctioned”. Mr Adams added the Government would not allow the sanctions to "distract attention from the gross human rights violations" taking place. However, Tim Loughton, a former minister who was also placed on the sanctions list, demanded assurances from ministers that no new agreements with China would take place while the sanctions remained in force. Sir Iain Duncan Smith, another on the sanctions list, said: “Given that China has sanctioned British politicians...surely is the time now for the Government...to say to China there can be no preferential trade, economic or commercial deals done whilst their own citizens are sanctioned.”