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The ambitious drive to produce Covid-19 vaccine at warp speed seems to be running up against reality. We all probably need to reset our expectations about how quickly we’re going to be able to be vaccinated.

Pauses in clinical trials to investigate potential safety issues, a slower-than-expected rate of infections among participants in at least one of the trials, and signals that an expert panel advising the Food and Drug Administration may not be comfortable recommending use of vaccines on very limited safety and efficacy data appear to be adding up to a slippage in the estimates of when vaccine will be ready to be deployed.

Asked Wednesday about when he expects the FDA will greenlight use of the first vaccines, Anthony Fauci moved the administration’s stated goalpost.

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“Could be January, could be later. We don’t know,” Fauci, director of the National Institute of Allergy and Infectious Diseases, said in an online interview with JAMA editor Howard Bauchner.

On Tuesday, front-runner Pfizer revealed in an earnings call that the first interim analysis in its Phase 3 clinical trial has not yet occurred. That means there hadn’t yet been enough Covid infections among the trial participants to take a first stab at analyzing whether the people randomly assigned to receive vaccine were infected at a lower rate than people who were assigned to get a placebo injection.

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It’s possible that the company will cross that threshold sooner rather than later. But Pfizer, which has been one of the most aggressive players in the vaccine race, had earlier predicted it would know by the end of September if its vaccine worked — an estimate that was later pushed back to late October. The company now projects that it could apply to the FDA for an emergency use authorization for the vaccine, which it is developing with BioNTech, in mid-November.

It is important to note that, to date, none of the vaccines being developed for the U.S. market has been proven to be effective in preventing Covid-19 disease. Early stage clinical trials have shown what appear to be promising signals; multiple vaccines have triggered production of important antibodies in people who have been immunized.

But data generated in a few hundred people aren’t enough to determine whether a vaccine will actually fend off illness. That answer comes from large, Phase 3 trials, five of which are now underway in the United States. Their findings will ultimately tell us how soon vaccines may start to be rolled out to the masses.

The administration has been saying for months that vaccine would be ready for deployment before the end of the year. In fact, President Trump had been hinting vaccine could be pushed out before Election Day, which it will not be; at a campaign rally on Wednesday night, he said vaccine would be ready “momentarily.”

Other officials have been bullish in their own right. Just last Friday, Paul Mango, deputy chief of staff for policy for Health and Human Services Secretary Alex Azar, reiterated the administration’s projection that all Americans who want to be vaccinated against Covid-19 will have that opportunity by the early spring.

“We believe before the end of this year we will be able to vaccinate our most vulnerable citizens,” Mango told journalists in an update on the work of Operation Warp Speed, the government’s effort to fast-track Covid-19 vaccines, drugs, and diagnostics.

“By the end of January, we believe we’ll be able to vaccinate all seniors. By the March and April timeframe, we believe we’ll be able to vaccinate any American who desires a vaccination,” Mango said.

In reality, that timeline has always been aspirational — probably excessively so. While Warp Speed and vaccine manufacturers and others involved in the effort have moved heaven and earth to accelerate vaccine production, at the end of the day, developing, testing, and manufacturing vaccines takes time. Vaccines are difficult to produce and there are always bumps in the road.

“While it’s unfortunate, I don’t find it surprising that the timeline is being moved back,” said Michael Osterholm, director of the University of Minnesota’s Center for Infectious Diseases Research and Policy. “Clinical trials like this routinely have unexpected occurrences that delay planned timelines. It’s just not unexpected.”

As for the idea that all Americans will have had a chance to be vaccinated by the early spring, Osterholm suggested it is going to take longer.

“For many of us, we never thought that that was doable,” he said. “I commend Operation Warp Speed for what it has accomplished in the time it has, but to have vaccinated the U.S. population by March in my mind was never a realistic goal.”

Two of the vaccines being supported by Operation Warp Speed have seen their Phase 3 trials paused to investigate unexpected illnesses among a small number of trial participants.

AstraZeneca, which in June projected it could begin to supply up to 2 billion doses of vaccine in September, instead saw its Phase 3 trials in multiple countries put on hold when a participant experienced neurological symptoms that chairman Pascal Soriot said were consistent with transverse myelitis, a serious inflammatory disorder. While regulators in Britain, India, and South Africa quickly cleared Phase 3 trials to resume enrolling volunteers, the U.S. trial was paused for five weeks.

Johnson & Johnson, the only manufacturer among the major vaccine makers testing a one-dose Covid vaccine, also saw its Phase 3 trial paused for two weeks after a male volunteer in his 20s suffered what the Washington Post reported to be a stroke.

After an investigation, the FDA allowed J&J to resume the trial.

Another manufacturer, Novavax, has pushed back the start date for its U.S. Phase 3 trial to the end of November; it had earlier said the trial would start this month.

Anna Durbin, a vaccine researcher at Johns Hopkins Bloomberg School of Public Health, said the public needs to understand that Covid vaccines may be a bit further off than people have been led to believe.

“We may see efficacy in one or more trials by the end of 2020, but that doesn’t mean we’re going to have a vaccine available at the end of 2020,” she said.

“I think what people can take from this is that the process is not being rushed…. That’s a good thing,” Durbin said. “And certainly, I think the other message that has to be heard loud and clear is that even when an [emergency use authorization] is issued, we’re not going to have enough vaccine for everybody [immediately].”

  • How many lives have been and are being lost to Covid, how many lives lost to suicide, overdose, lack of preventative healthcare, how many billions/trillions of dollars lost, how many thousands or millions of businesses closed while the world is waiting for phase 3 trials to finish? WHY WEREN’T CHALLENGE TRIALS USED????? Tens of thousands of volunteers were willing and available for challenge trials. We would have had answers to effectiveness in a matter of weeks…likely in July or August. Millions would’ve already been vaccinated by now and thousands of lives likely saved. But instead we plod on and let thousands dies everyday.

    • Challenge trials would be only a modest benefit, if any. Normally, it takes more time to prove safety than efficacy, and that is expected to be the case here: each trial is supposed to wait until the median patient has had two months since the last dose, which puts us into the 3rd week of November. Verifying the efficacy would be reassuring, but doesn’t really effect anything downstream. Most of the manufacturers claim that they’re already ramping up the manufacturing as fast as possible, so getting things approved a month earlier isn’t going to effect the number of people vaccinated by the end of February much–we’ll have delivered all the doses we have available, which won’t be enough.

  • This article doesn’t mention that Moderna is actively preparing for its global launch. It is seeking the real-time reviews from the European countries and Canada simultaneously. Reuters reported on Oct. 27 that Moderna has begun a rolling data submission to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for it to start its independent assessment of evidence as and when it becomes available. Also, it is in ongoing talks with the World Health Organization-backed COVAX initiative, and has had per-orders from Switzerland, Japan, Canada, Israel and Qatar. Moderna announced it is ready to ship 20 million doses by the end of 2020, if approved. So, it sounds like other countries may jump ahead of the US in receiving the Moderna vaccines, if licenses are approved elsewhere first.

  • The common man in the street is always at the mercy of corrupt and over zealous politicians who overrides science for the sake of political expediency. In the end the common man bears the consequences of the politician’s failure.

  • When will everyone receive a vaccine for the coronavirus and what’s it going to take to end this pandemic?

  • It seems clear to me this author has the same view and the self-serving attitude as our President, i.e., America First. There are hundreds and thousands of citizens already being aggressively vaccinated in China in large numbers (healthcare workers, military, and even students). But not even a word from her out it? Why? Oops I forgot. Just like the Presidedent, perhaps she feels anything and everything about Covid-19 coming ftom China is not reliable, not trustworthy, mostly fake news thus should be ignored or dismissed!

    Yup here we go again! America first, our vaccine here is the best, the most reliable, should be the first to be dustributed widely around the world, our best medical science would save the day and the world! How arrogant and pathetic but certainly not surprising!

    • Amen. I’m glad I’m “pandemic-stranded” from US in my native Brazil, where I’m way more likely to have access to a vaccine faster, regardless of its nationality. This xenophobia nonsense in science must stop. Science is science and has no borders.

    • If China is so great perhaps you should get out of the free world and jump on the communist band wagon. America doesn’t want or need to hear that kind of garbage; It is of no value

    • @John Chu: You got it all wrong. The author is presenting a revised timeline about the availability of vaccines within the US market. It has nothing to do with “America First”. Some vaccines mentioned by the author are not even developed by Americans, but they are all undergoing clinical trials in the US right now. For instance, AstraZeneca is a British-Swedish pharma company and its covid vaccine candidate is developed by Oxford’s Jenner Institute. The Pfizer/BioNTech was developed by the German company BioNTech. It is unlikely for the US government to approve any vaccine that has not gone through clinical trials in the US, yet so far none of the vaccines developed in China has applied for trials in the US. The author has even omitted the Moderna/NIAID vaccine, developed by a US company and a branch of the US government, even though it is on track to summit its interim results in late November and possibly apply for emergency use in December.

      The Chinese government has approved 3 vaccines for emergency use inside of China, but none of them seem to have completed clinical trials. The New York Time has a report on them.
      https://www.nytimes.com/2020/09/26/business/china-coronavirus-vaccine.html
      The memory of the 2017-18 scandals of the Chinese Changchun vaccines is still fresh. Unfortunately, it will take some time before people trust the Chinese vaccines again.

  • Hello – this and many stories like it demonstrate the medical drug/vaccine bureaucracy’s bias against speed – these people routinely talk about vaccine development takes years so don’t expect anything in less than year or two – do they not realize we have a pandemic on our hands that kills close to a 1000 people a day in the U.S. alone? – this is not a science decision but a societal one that has to be made about the cost benefits – 1000 deaths per day from vaccine vs. no deaths per day for the tens of thousands of people that have received the actual vaccine in trials – do you really want to wait months to see if enough of the placebo group gets infected? – we need to rely far less on trials and far more on the known molecular structure of the vaccine and the virus, along with the ability to do hundreds of billions of simulations of potential adverse interactions – people should be demanding the “right to try” on existing vaccines and not sitting around like sheep waiting to get infected and waiting for the whole economic system to collapse!! – going forward we need a 2 month vaccine development and approval/commercialization process for any new viruses and not one year – we already can develop the vaccine in weeks but he regulators are taking far too long using out of date concepts like trials (throwing 15,000 or so people against the placebo wall and seeing if they get the virus vs. 15,000 that get the vaccine and seeing if they get the virus) – there should be an uprising against the regulators – hopefully Europe and China will at least start vaccinating medical workers at a minimum starting now and even before emergency use authorization – dont let these FDA regulators kill you and your family in the name of their perfect long term trials! -John

  • The real tragedy is that many doctors have used protocols involving vitamin A, C, and D3 plus zinc, and another one using hydroxychloroquine and zinc and azithromycin, that have been very successful in getting patients better in less than a week but some is shutting them down. If it works, it is a crime not to use it no matter how much Dr Faucci stands to earn from a vaccine. Doctors have never been shut down before and there are hundreds of them being silenced… THAT IS WHERE THE REAL STORY IS!!!

    • Please stop spreading misinformation. Those drugs were shown not to speed up healing, and actually caused more deaths due to heart problems

  • I am so sick and tired of these post that say.. Lets hold off.. Lets wait.. Lets see if this is 100% safe.. Come on guys.. we are killing almost 30,000 people a month.. Phase 3 has shown this this is safe.. Nobody has grown a third arm or dropped dead.. Lets get this stupid thing rolled out ASAP!!!

    • So far, safety looks pretty good. What they are looking for is proof that the vaccine actually is a vaccine, that is, that it prevents COVID or makes COVID less harmful. Sometimes you have to wait for that second marshmallow.

    • There are two factors that should make people hesitant to just vaccinating people with whatever a company can come up with.
      1) Only about 33% of vaccines make it through the Phase 3 clinical trial. So they aren’t effective or they aren’t safe.
      2) The early vaccine candidates tend to be mRNA-based vaccines. So far there have been attempts, but no successful mRNA vaccines. Moderna seems like a bit of a sketchy company to me, so I am kind of skeptical that it will be successful.

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