When Will You Be In a position to Get a Coronavirus Vaccine?

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When Will You Be Able to Get a Coronavirus Vaccine?

Americans are dying to know when a coronavirus vaccine will be available to finally contain the pandemic that has killed nearly 200,000 people in the United States, and to allow schools and the economy as a whole to reopen.

Scientists and vaccine makers have long said that a handful of vaccines could be available by the end of the year if everything goes according to plan. For the past few weeks, however, President Trump has insisted that a vaccine be ready before the November 3rd presidential election, raising fears that advice from scientists and regulators could be challenged.

Testing and manufacturing a vaccine is a complex process with many uncertainties. However, the best guess right now, experts say, if every aspect of vaccine development and distribution goes exactly as planned – and history has shown this rarely happens – certain people in risk groups could be vaccinated this year. Most other Americans, however, will most likely have to wait well into next year.

At a press conference Wednesday night, Mr Trump doubled that unrealistic schedule, saying a vaccine could be ready by mid-October and then be made available to the public "immediately".

"We don't want to say," Gee, in six months we are going to start giving it to the public, "he said.

In doing so, he contradicted his own director of the Centers for Disease Control and Prevention, Dr. Robert R. Redfield, who testified earlier that day that a vaccine would most likely not be available until mid-next year. Mr Trump's statements also contrasted with comments made Wednesday morning by officials from Operation Warp Speed, a federal effort to expedite a vaccine, who said supplies would be available in the first few months that a vaccine is available is, would be limited.

It wasn't the first time the President had put forward an accelerated timetable. Just the night before, at a town hall meeting hosted by ABC News, he said one could be available in three to four weeks.

Dr. Redfield is in line with best estimates by other vaccine experts that the general public will not have access to the vaccine until February at the earliest, and possibly earlier than July or August.

Of the three companies with vaccines in late-stage clinical trials in the United States, only one – Pfizer – said initial results could be seen by the end of October. The other two companies, Moderna and AstraZeneca, were more vague, just saying they hope for results before the end of the year. If a coronavirus vaccine showed results this year, it would destroy the previous record of four years for a new vaccine to develop.

Dr. Paul Offit, a professor at the University of Pennsylvania and a member of the Food and Drug Administration's Vaccine Advisory Board, was skeptical that Pfizer could be so sure of its schedule. "I think it's irresponsible – they don't know," he said. "I think the more responsible answer is," Hopefully we'll know something by early next year. "That seems like the most likely scenario to me."

Moderna's top executives said in interviews this week that they could see initial results by November. However, a test plan released by the company Thursday indicated an even longer period, suggesting that the initial analysis of the test data may not be done until late December and that there may not be enough information to determine if the vaccine is working. Later analyzes, slated for March and May, are more likely to provide an answer, the company said in its blueprint. (A company spokesperson said the November estimate was an updated estimate of what was on the blueprint.)

AstraZeneca's timeline is also in question after global trials were halted earlier this month because of a participant who developed severe neurological symptoms after receiving the experimental vaccine. The company has not released details about the person's health status, nor has it disclosed whether the reaction was due to the vaccine. The trials have since resumed in the United Kingdom and Brazil, but not in the United States, where they have been suspended since September 6th.

Independent expert panels regularly review the data during ongoing clinical studies. If the vaccine shows signs of being extremely effective, the Board could decide that it would be unethical to continue the study and keep giving some participants a placebo. This external body could also ask a company to abandon a process if it does not prevent Covid-19 cases or if there are serious security concerns.

Whether the vaccine is effective is determined by comparing the number of people in each group – the vaccine group and the placebo group – who will develop the disease. If many more people in the placebo group get infected, it means the vaccine is working. As a result, the speed of the trials will depend on how quickly the virus spreads in the communities where trials are being conducted. The organizers try to guess where infections are increasing and set up experiments there. However, in a fast-moving pandemic, this isn't always easy.

Pauses in testing for safety reasons – like the one recently announced by AstraZeneca – could also slow the time down, even if it turns out the safety issues are ultimately unrelated to the vaccine.

Once the results are in, the Food and Drug Administration will review the data and issue either an emergency permit – most likely for certain high-risk groups of people such as healthcare workers – or a broader permit for commercial approval. In any case, the agency has announced that it will consult an expert advisory board before making a decision.

Companies are in contact with F.D.A. Officials along the way and many experts predict that the agency will be able to approve an emergency permit within days if the results are clear enough.

The best guess from scientists, investors, and federal health officials is the first half of next year.

Even if one of the top runners gets a response on their vaccine this year, too few vaccines have been made to be distributed to the public. The head of Operation Warp Speed, Dr. Moncef Slaoui told NPR that he estimated that around 20 to 30 million doses of a vaccine would be ready by the end of the year, far less than the 100 million doses Mr Trump said Wednesday. (The top of the line vaccines require every two doses several weeks apart, which further complicates the process.)

Dr. Slaoui also recently said that Americans would most likely not be fully vaccinated until mid-2021 and that the chance of getting a vaccine by October or November was "extremely unlikely".

The first months of a vaccine's availability will limit access to risk groups such as the elderly or health care workers and police officers.

Peter Lurie, President of the Center for Science in the Public Interest and former F.D.A. Officials, he said, it is not unreasonable to expect the first batches for high priority groups to be ready by February – “when everything is lined up. And the lesson from drug development is that hardly everything is lined up. "

Earlier this month, the C.D.C. told public health officials that two million doses of a vaccine could be available by the end of October, with 10 to 20 million doses potentially available by November and 20 to 30 million by the end of December.

In a briefing for reporters Wednesday, Operation Warp Speed ​​officials described the first few months of vaccine availability as a "restricted" period during which it would only be available to high-priority groups.

These groups alone comprise millions of people. At a recent meeting of the CDC's Advisory Committee on Immunization Practices, an agency official presented a slide showing that there are up to 20 million healthcare workers, up to 80 million key workers, and approximately 53 million people in the United States older than 65 years. Each of these people would need two doses of the vaccine to be effective.

For everyone else, timing will depend on the speed of manufacture and distribution, as well as the willingness of the public to actually get vaccinated.

At best, additional vaccines could become available to the public early next year. Johnson & Johnson has announced that it will begin late-stage trials of its vaccine this month and another company, Novavax, may begin the trial soon.

Stéphane Bancel, CEO of Moderna, said in an interview on Wednesday that he expected a global shortage of vaccines well into next year. "For the first half of next year, at least maybe until Labor Day next year, I expect the world will be massively supply-linked, which means there won't be enough vaccine to keep everyone vaccinated" said Bancel.

And that assumes that everyone wants to take a vaccine. Recent surveys have shown that this is not necessarily the case, especially if the vaccine was launched for political reasons.

Carl Zimmer contributed to the coverage.

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