AstraZeneca’s COVID-19 vaccine shows success: Here’s how it stacks up to others

Vials in front of the AstraZeneca British biopharmaceutical company logo are seen in this creative photo taken on 18 November 2020.

Enlarge / Vials in front of the AstraZeneca British biopharmaceutical company logo are seen in this creative photo taken on 18 November 2020. (credit: Getty| NurPhoto)

AstraZeneca announced in a press release on Monday that its COVID-19 vaccine showed positive results in an interim analysis of clinical trial data.

The announcement marks the third vaccine to show strong efficacy in late-stage trials against the pandemic coronavirus, SARS-CoV-2. Though AstraZeneca’s vaccine efficacy numbers are not as impressively high as those for the vaccines before it—mRNA vaccines from Pfizer/BioNTech and Moderna—AstraZeneca’s does offer some advantages over those vaccines.

In all, the news adds to ballooning optimism that effective vaccines could bring an end to the global crisis in the coming year.

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Oxford University’s COVID-19 vaccine shows high efficacy, and is cheaper to make and easier to store

Oxford University’s COVID-19 vaccine, being developed in partnership with drugmaker AstraZeneca, has shown to be 70.4% effective in preliminary results from its Phase 3 clinical trial. That rate actually includes data from two different approaches to dosing, including one where two full strength does were applied, which was 62% effective, and a much more promising dosage trial which used one half-dose and one full strength dose to follow – that one was 90% effective.

Oxford’s results may not have the eye-catching high efficacy headline totals of the recent announcements from Pfizer and Moderna, but they could actually represent some of the most promising yet for a few different reasons. First, if that second dosage strategy holds true across later results and further analysis, it means that the Oxford vaccine can be administered in lower amounts and provide stronger efficacy (there’s no reason to use the full two-dose method if it’s that much less effective).

Second, the Oxford vaccine can be stored and transported at standard refrigerator temperatures – between 35° and 45°F – whereas the other two vaccine candidates require storage at lower temperatures. That helps obviate the need for more specialized equipment during transportation and on-site at clinics and hospitals where it will be administered.

Oxford’s COVID-19 vaccine also uses a different approach to either Moderna’s or Pfizer’s, which are both mRNA vaccines. That’s a relatively unproven technology when it comes to human therapeutics, which involves using messenger RNA to provide blueprints to a person’s body to build proteins effective at blocking a virus, without any virus present. The Oxford University candidate is an adenovirus vaccine, which is a much more established technology that’s already been in use for decades, and which involves genetically altering a weekend common cold virus and using that to trigger a person’s own natural immune response.

Finally, it’s also cheaper – in part because it uses tried and tested technology for which there’s already a robust and mature supply chain, and in part because it’s easier to transport and store.

The Phase 3 trial for the Oxford vaccine included 24,000 participants, and it’s expected to grow to 60,000 by the end of the year. Safety data so far shows no significant risks, and among the 131 confirmed cases in the interim analysis that produced these results, none of those who received either vaccine dosage developed a severe case, or one requiring hospitalization.

This is great news for potential vaccination programs, since it introduces variety of supply chain into an apparently effective vaccine treatment for COVID-19. We’re much better off if we have not only multiple effective vaccines, but multiple different types of effective vaccines, in terms of being able to inoculate widely as quickly as possible.

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The US now seems to be pinning all of its hopes on COVID-19 therapies and vaccines

Almost eight months after the White House first announced it would move from containment to mitigation efforts to stop the spread of the COVID-19 epidemic, the Administration is now pinning its hopes on vaccines to inoculate the population and therapies to treat the disease.

Months after announcing it would be working with technology giants Apple and Google on a contact tracing app (and nearly two months after Google and Apple rolled out their exposure notification features) and initiating wide spread testing efforts nationwide with the largest national pharmacies (which never received the coordinated support it needed),  the Administration appears to be giving up on a national effort to stop the spread of the COVID-19 epidemic.

In an interview with CNN’s Jake Tapper White House Chief of Staff Mark Meadows said that the US is “not going to control the pandemic… We are gonna control the fact that we get vaccines, therapeutics and other mitigation.”

The admission is a final nail in the coffin for a federal response that could have involved a return to lockdowns to stop the spread of the virus, or national testing and contact tracing and other mitigation measures. Meadows statement comes as the US experiences a second peak in infection rates. There are now over 8.1 million cases and over 220,000 deaths since the first confirmed infection on US soil on January 20. 

Now, the focus is all on the vaccines, therapies and treatments being developed by large pharma companies and startups alike that are making their way through the approval processes of regulatory agencies around the world.

The vaccines in phase three clinical trials

There are currently 12 vaccines in large scale, late-stage clinical trials around the world, including ones from American companies Novavax, Johnson & Johnson, Moderna Therapeutics, and Pfizer who are recruiting tens of thousands of people in the US and UK to volunteer for testing.

In China, the state run pharmaceutical company Sinopharm has filed its application to China’s regulatory commission for the approval of a vaccine and hundreds of thousands of civilians have already been vaccinated under emergency use approvals from the Chinese government, according to a report in the New Yorker. Meanwhile the privately held Chinese pharmaceutical company, Sinovac, is moving forward with phase three trials for its own vaccine in Brazil, Bangladesh and Indonesia. Another private Chinese company, CanSino Biologics developed a vaccine that was already being distributed to members of the Chinese military in late July,

A collaboration in the U.K. between the University of Oxford and European pharmaceutical company AstraZeneca is also recruiting volunteers in Brazil, India, the United Kingdom, the US and South Africa. And, in Australia, the Murdoch Children’s Research Institute is trying to see whether a vaccine used to prevent tuberculosis could be used to vaccinate against the coronavirus.

Finally in Russia, the Gamaleya National Center of Epidemiology and Microbiology in partnership with the state-run Russian Direct Investment Fund have claimed to have developed a vaccine that the country has registered as the first one on the market cleared for widespread use. Russia has not published any data from the clinical trials it claims to have conducted to prove the efficacy of the vaccine and the World Health Organization still considers the treatment to be in the first phase of development.

Therapies in phase three clinical trials

If vaccines can prevent against infection, a slew of companies are also working on ways to limit the severity of the disease should someone become infected with Sars-Cov-2, the novel coronavirus that causes COVID-19.

The Milken Institute lists 41 different therapies that have made it through to phase three of their clinical trials (the last phase before approval for widespread delivery).

These therapies come in one of five primary categories: antibody therapies, antivirals, cell-based therapies, RNA-based treatments, and repurposing existing treatments that may be in pharmaceutical purgatory.

Antibody therapies use the body’s natural defense systems either taken from the blood of people who have recovered from an infection or manufactured in a lab to neutralize the spread of a virus or bacteria. Antivirals, by contrast, stop a virus from spreading by attacking the viruses’ ability to replicate. Cell-based therapies are designed to boost the immune system’s ability to fight pathogens like viruses or bacteria. Meanwhile RNA-based treatments are another method to stop the virus from replicating by blocking the construction of viral proteins. Finally, several companies are mining their libraries of old drug compounds to see if any might be candidates for COVID-19 treatments.

So far, only three therapeutics have been approved to treat COVID-19. In the U.K. and Japan dexamethasone has received approvals, while favilavir is being used in China, Italy and Russia; and — famously thanks to its use by the President — remdesivir has been approved in the United States, Japan and Australia.

The US is also using convalescent plasma to treat hospitalized patients under emergency use authorizations. And special cases, like the President’s, have had access to other experimental treatments like Regeneron’s cell therapy under emergency use authorizations.

And there are several US-based startups developing potential COVID-19 therapies in each of these areas.

Adaptive Biotechnologies, Cytovia Therapeutics, and SAB Biotherapeutics are all developing antibody treatments. Applied Therapeutics is using an understanding of existing compounds to develop treatments for specific conditions associated with COVID-19. Cellularity has a cell-therapy that could reduce a patient’s viral load by stimulating so-called natural killer cells to attack infected cells. Humanigen has developed a new drug that could reduce fatalities in high-risk COVID-19 patients with severe pneumonia. Meanwhile Partner Therapeutics is working on a drug that could improve lung function in COVID-19 patients — and potentially boost antibody production against the virus and restore damaged lung cells. Finally, Sarepta Therapeutics has been working with the United States Army Medical Research Institute of Infectious Diseases to find ways for its RNA-based treatment to stop the spread of coronaviruses by attacking the ability for the virus to replicate.

Beyond therapies, startups are finding other ways to play a role in helping the nation address the COVID-19 epidemic.

“At this point the U.S. doesn’t have the best public health system, but at the same time we have best-in-class private companies who can sometimes operate a lot more efficiently than governments can,” Carbon Health chief executive Eran Bali told the audience at TechCrunch’s Disrupt 2020 conference. “We also just recently launched a program to help COVID-positive patients get back to health quickly, a rehabilitation program. Because as you know even if you survive it doesn’t mean your body was not affected, there are permanent effects.”

Indeed the drive for more effective at-home tests and remote treatments for consumers are arguably more important when the federal government refuses to make the prevention of viral spread a priority, because consumers may voluntarily lock down if the government won’t.

“This is an opportunity to take a technology that naturally is all about detecting viruses — that’s what CRISPR does in [its native environment] bacteria — and repurposing it to use it as a rapid diagnostic for coronavirus,” said the Nobel Prize-winning co-inventor of some foundational CRISPR gene-editing technology, Jennifer Doudna. “We’re finding in the laboratory that that means that you can get a signal faster, and you can also get a signal that is more directly correlated to the level of the virus.”

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“Not uncommon at all”: AstraZeneca pauses COVID-19 vaccine trial

A double-masked health care worker jabs a needle into the arm of a seated woman in a mask.

Enlarge / A volunteer receives an injection of AZD1222 from a medical worker during the country’s first human clinical trial for a potential vaccine against COVID-19 at the Baragwanath Hospital on June 28, 2020, in Soweto, South Africa. It is reported that Africa’s first COVID-19 vaccine trial began on June 24 in South Africa. (credit: Getty Images | Felix Dlangamandla)

With the coronavirus crisis gripping the globe, all eyes are on every bump and dip on the path to the pandemic’s end. So, of course, news that researchers triggered a common pause to the clinical trials of a leading COVID-19 vaccine candidate made swift and alarming headlines late Tuesday.

The global phase III trials for the vaccine AZD1222 (formerly ChAdOx1)—developed by the University of Oxford and pharmaceutical giant AstraZeneca—were put on a “temporary” and “voluntary” pause for a “standard review process,” AstraZeneca said in a statement Wednesday.

According the company, the pause was triggered by a “potentially unexplained illness” in one of thousands of participants involved in its trials. Per standard protocol, researchers must pause the trial to investigate whether the illness is related to exposure to the experimental vaccine or not.

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COVID vaccine makers vow science—not Trump—will dictate release timing

Woman receives an experimental COVID-19 vaccine at the University of Massachusetts Medical School in Worcester, MA on September 04, 2020, as part of a clinical trial.

Enlarge / Woman receives an experimental COVID-19 vaccine at the University of Massachusetts Medical School in Worcester, MA on September 04, 2020, as part of a clinical trial. (credit: Getty | Boston Globe)

In an extraordinary move Tuesday, nine top pharmaceutical executives made a public pledge that they will not prematurely release a COVID-19 vaccine and that they will only seek federal approval to distribute a vaccine after rigorous ethical and scientific standards are met.

The pledge was signed by the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi. All of the represented companies are working on a vaccine against COVID-19 and four—AstraZeneca, Moderna, and a joint venture between BioNTech and Pfizer—have vaccines in phase 3 clinical trials.

The vow appears to be a coordinated resistance to pressure from the Trump administration, which is pushing for a rollout of a vaccine by November 1, just before the presidential election. Last week, the Centers for Disease Control and Prevention told states to be ready to start distributing vaccines by November 1.

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Meet the 4 frontrunners in the COVID-19 vaccine race

A volunteer receives an injection from a medical worker during the country's first human clinical trial for a potential vaccine against COVID-19 at the Baragwanath Hospital on June 28, 2020 in Soweto, South Africa. It is reported that Africa's first COVID-19 vaccine trial began on June 24 in South Africa. The vaccine, developed by Oxford University's (UK) Jenner Institute, will inoculate 2,000 South Africans.

Enlarge / A volunteer receives an injection from a medical worker during the country’s first human clinical trial for a potential vaccine against COVID-19 at the Baragwanath Hospital on June 28, 2020 in Soweto, South Africa. It is reported that Africa’s first COVID-19 vaccine trial began on June 24 in South Africa. The vaccine, developed by Oxford University’s (UK) Jenner Institute, will inoculate 2,000 South Africans. (credit: Getty | Felix Dlangamandla)

Researchers have now reported data from early (and small) clinical trials of four candidate COVID-19 vaccines.

So far, the data is positive. The vaccines appear to be generally safe, and they spur immune responses against the novel coronavirus, SARS-CoV-2. But whether these immune responses are enough to protect people from infection and disease remains an important unknown.

The four candidates are now headed to larger trials—phase III trials—that will put them to the ultimate test: can they protect people from COVID-19 and end this pandemic?

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Moderna set to start final-stage trial of its coronavirus vaccine by July

Pharmaceutical company Moderna told Bloomberg on Thursday that it’s on pace to begin the final-stage clinical trial of its vaccine for the novel coronavirus that causes COVID-19 by July. Moderna was the first company to begin human clinical trials of its vaccine candidate in the U.S., and the last stage of its study will include 30,000 people and be conducted in partnership with the U.S. National Institute of Allergy and Infectious Diseases (NIAID).

The aim of the study will be to show definitive clinical proof that Moderna’s vaccine actually does prevent people from developing COVID-19, and, secondarily, that it prevents at least severe symptoms and cases that require hospitalization from materializing. Moderna’s second-stage clinical trial kicked off last month, and the company has previously said that it could potentially begin offering experimental doses available to healthcare workers in limited capacities as early as this fall.

The pace of development of a number of leading vaccine candidates is actually moving just as quickly, if not more quickly. Johnson & Johnson said early this week that it would start trials of its vaccine later in July, while AstraZeneca and its research and development partner the University of Oxford will be entering its own final-stage clinical trials as of this month.

Moderna’s vaccine candidate is an mRNA vaccine, which is a technology that essentially provides instructions to healthy cells to produce antibodies to the coronavirus, without having to actually introduce any of the active or inactive virus itself. mRNA vaccines, while used in veterinary medicines, are relatively new technology and have not yet been approved for use in human patients, but they represent a number of the early vaccine attempts, because of their advantages in terms of speed of development and the lessened theoretical health risk they pose to people, including early trial participants.

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