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US states told be ready to distribute COVID-19 vaccine by November 1

COVID-19 vaccine: Priority will be given to essential workers, national security officials, seniors and members of vulnerable racial and ethnic groups.

September 04, 2020 / 09:11 AM IST
2 | Next crop of COVID-19 vaccine developers take more traditional route: The handful of drugmakers dominating the global coronavirus vaccine race are pushing the boundaries of vaccine technology. The next crop under development feature more conventional, proven designs. The world will need several different vaccines to fight the COVID-19 pandemic, given the sheer size of global need, variations in effects on different populations, and possible limits of effectiveness in the first crop. Many leading candidates now in final-stage testing are based on new, largely unproven technology platforms designed to produce vaccines at speed.

2 | Next crop of COVID-19 vaccine developers take more traditional route: The handful of drugmakers dominating the global coronavirus vaccine race are pushing the boundaries of vaccine technology. The next crop under development feature more conventional, proven designs. The world will need several different vaccines to fight the COVID-19 pandemic, given the sheer size of global need, variations in effects on different populations, and possible limits of effectiveness in the first crop. Many leading candidates now in final-stage testing are based on new, largely unproven technology platforms designed to produce vaccines at speed.


The Trump administration has urged states in the US to get ready to distribute a potential COVID-19 vaccine by November 1 -- two days before the presidential election.

Dallas-based wholesaler McKesson Corp. has a deal with the federal government and will be requesting permits to set up distribution centers when a vaccine becomes available.

"The normal time required to obtain these permits presents a significant barrier to the success of this urgent public health program," Robert Redfield, director of the Centers for Disease Control and Prevention, told states in an August 27 letter.

"CDC urgently requests your assistance in expediting applications for these distribution facilities."

Redfield asked states to consider waiving requirements that would "prevent these facilities from becoming fully operational by Nov. 1, 2020."

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COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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The CDC provided states with documents giving details of a vaccine rollout plan, adding that they would either be approved as licensed vaccines or under emergency use authorization.

Recipients would probably require a second "booster" dose, a few weeks after the first, according to the documents.

"Vaccine and ancillary supplies will be procured and distributed by the federal government at no cost to enrolled Covid-19 vaccination providers," say the documents, which also went to New York City, Chicago, Houston, Philadelphia and San Antonio.

Follow Moneycontrol’s COVID vaccine tracker for more

Serious side effects

Priority will be given to essential workers, national security officials, seniors and members of vulnerable racial and ethnic groups, according to The New York Times.

Three Western drug makers are progressing with their Phase 3 clinical trials, involving tens of thousands of participants.

The three are AstraZeneca, which is partnering with Oxford University in England; Moderna, collaborating with the US National Institutes of Health; and the Pfizer/BioNTech alliance.

By the nature of the trials, it is difficult to predict when reliable results will emerge.

Half of the participants in such trials receive an experimental vaccine, while the other half are given a placebo.

Under normal procedures, test administrators must wait -- probably for months -- to see whether there is a statistically significant difference in the infection rate of the two groups.

The US Food and Drug Administration however has raised the possibility that a vaccine might be given emergency approval before the end of trials.

A request for such extraordinary approval would have to come from the vaccine developer, FDA chief Stephen Hahn told the Financial Times in an interview published Sunday.

The FDA has faced mounting criticism from the medical community that it is bowing to political pressure from President Donald Trump, who has been pushing hard for a vaccine, saying one might be ready before the election.

In March, the FDA gave emergency authorization for the use of hydroxychloroquine to treat Covid-19 after Trump repeatedly praised its use; the authorization had to be withdrawn in June after serious side effects emerged.

Follow our LIVE blog for the latest updates of the novel coronavirus pandemic

'Safe and effective'

More recently, Hahn delivered a far too optimistic appraisal, during a news conference with Trump, of the effectiveness of convalescent plasma against the virus.

He said it could save 35 out of 100 patients; the more likely number, experts said, is five in 100.

"This means mass vaccination nationwide could start in 59 days. FIFTY-NINE DAYS. Is any #COVID19 #vaccine likely to have completed Phase 3 safety and efficacy clinical trials, and gone through full scientific and @US_FDA review in 59 days?" award-winning epidemiology writer Laurie Garrett asked on Twitter.

"To my knowledge, none of the US #COVID19 #vaccines have finished even enrolling test subjects for Phase 3 trials. Rushing this to completion within 59 days is DANGEROUS."

Hahn, however, has insisted he is not acting under pressure from Trump, arguing that any vaccine approval would be a "science, medicine, data decision."

Top government scientist Anthony Fauci has said on several occasions that a vaccine should be ready between the end of 2020 and the first half of 2021.

"I believe that by the time we get to the end of this calendar year that we will feel comfortable that we do have a safe and effective vaccine," Fauci told NBC.

The US has registered more than six million COVID-19 cases -- almost a quarter of the global total -- and 185,000 deaths, according to Baltimore-based Johns Hopkins University.

Click here for Moneycontrol’s full coverage of the novel coronavirus pandemic
AFP
first published: Sep 4, 2020 09:02 am

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