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Health Canada authorizes AstraZeneca’s COVID-19 vaccine

[Photo by Praveen Kumar Nandagiri on Unsplash]

Health Canada today announced the authorization of the COVID-19 vaccine developed by AstraZeneca and Oxford University — the third vaccine for the novel coronavirus authorized in Canada.

“This is very encouraging news. It means more people vaccinated, and sooner. Because for AstraZeneca, just like we were for Pfizer and Moderna, we are ready to get doses rolling,” said Prime Minister Justin Trudeau, as recounted by CBC.

“Vaccines will keep arriving faster and faster as we head into the spring,” Trudeau said.

The Health Canada decision came after two studies — involving 11,636 participants in the U.K. and Brazil — showed an efficacy rate of 62.1% after two standard doses. The efficacy rate was 59.5% in an updated analysis in which the second dose was administered 4 to 12 weeks after the first dose.

On top of the AstraZe…

Several EU nations recommend older adults avoid AstraZeneca COVID-19 vaccine

Portugal health authorities recently recommended that AstraZeneca’s (LON:AZN) COVID-19 vaccine not be used for those who are over 65.

South Africa recently paused its deployment of the vaccine over worries that it is ineffective against a variant circulating there.

In addition to Portugal, several European countries have expressed reservations about the vaccine’s efficacy in older populations. France, Norway, Germany, Austria and others have decided to only administer the vaccine to those under 65. Poland has reserved the vaccine for those 60 and under, while Spain and Italy have recommended for recipients under 55.

The reservations of the E.U. nations stems in large from a data shortage. Two patients over 65 in the AstraZeneca trial contracted the virus, making it difficult to draw firm conclusions about its efficacy in that age group. There were 660 patients over 65 in the trial.

Portugal has had 765,000 COVID-19 cases and more than 14,000 d…

South Africa pauses rollout of AstraZeneca COVID-19 vaccine

South Africa has scrapped its plans to vaccinate a portion of its population with the COVID-19 vaccine from Oxford University and AstraZeneca (LON:AZN) after a small study showed it was ineffective against a variant widely circulating there.

In the interim, South Africa will rely on vaccines from Johnson & Johnson (NYSE:JNJ) and Pfizer (NYSE:PFE).

Researchers at Oxford University and the University of the Witwatersrand in South Africa found the AstraZeneca vaccine to offer little to no protection against mild-to-moderate disease. The research has not been peer-reviewed.

Get the full story from our sister site, Drug Discovery & Development.

South Africa pauses rollout of AstraZeneca COVID-19 vaccine

South Africa has scrapped its plans to vaccinate a portion of its population with the COVID-19 vaccine from Oxford University and AstraZeneca (LON:AZN) after a small study showed it was ineffective against a variant widely circulating there.

In the interim, South Africa will rely on vaccines from Johnson & Johnson (NYSE:JNJ) and Pfizer (NYSE:PFE).

Researchers at Oxford University and the University of the Witwatersrand in South Africa found the AstraZeneca vaccine to offer little to no protection against mild-to-moderate disease. The research has not been peer-reviewed.

Out of a pool of 748 study participants given the AstraZeneca vaccine, 19 contracted mild or moderate COVID-19 infections compared to 20 people in the placebo group of 714. There were no cases of severe illness in the trial, which did not include elderly participants. The median age in the trial was 31.

Before the recent trial data were announced, the country had amassed 1…

AstraZeneca vaccine could curb COVID-19 transmission

Hopes for COVID-19 vaccines to beat back the pandemic assumed mass-vaccination would slow viral transmission, and not just prevent moderate-to-severe disease.

Now, early data suggest that AstraZeneca’s (LON:AZN) COVID-19 vaccine, which it jointly developed with Oxford University, can curb viral transmission by up to 67%.

There was more good news from the data. The ChAdOx1 vaccine offered 100% protection against severe disease in a Phase 3 trial. A single vaccine dose offered 76% efficacy between 22 and 90 days after vaccination. Delaying the second dose of vaccine by 12 weeks appeared to boost efficacy to 82%. Efficacy fell to 55% when the gap between doses dropped to less than six weeks.

The study concluded that the U.K.’s strategy of aiming to vaccinate a large proportion of the population with the first dose before administering the second vaccine dose up to 12 weeks later is “an effective strategy.”

Also heartening is the fact that a porti…

Russia reports 91.6% efficacy for its Sputnik V COVID-19 vaccine

Sputnik V in vials. Image from Mos.ru via Wikipedia.

The Sputnik V COVID-19 vaccine could be more efficacious than those from AstraZeneca (LON:AZN) or Johnson & Johnson (NYSE:JNJ) based on interim trial results.

The two-dose Sputnik vaccine was 91.6% effective at preventing symptomatic COVID-19 and 100% effective at preventing severe and moderate disease in a study involving 19,866 participants.

The data were published in The Lancet. No data, however, was available on the impact of SARS-CoV-2 variants on the vaccine’s efficacy.

By comparison, the single-dose JNJ vaccine was 57% to 72% effective at preventing moderate to severe disease, depending on the geography. The vaccine was least effective in South Africa, where 95% of infections were the result of a more-infectious variant circulating there.

AstraZeneca’s (LON:AZN) two-dose vaccine was between 62% and 90% effective, depen…

Pharma researcher charged with theft of trade secrets

Image from Bill Oxford via Unsplash

A former director of medical and scientific affairs at Merck (NYSE:MRK) faces criminal charges in federal court in New Jersey for allegedly stealing and transmitting trade secrets.

Shafat A. Quadri has been released on $100,000 unsecured bond. He was most recently employed at AstraZeneca (NSDQ:AZN).

The single count of trade secret theft carries a maximum potential penalty of up to 10 years in prison and a fine as high as $250,000, or double the total financial gain or loss, according to Rachael A. Honig, acting U.S. attorney for the District of New Jersey.

The complaint describes Quadri’s former employer as “Company 1,” stating that the organization reached out to the FBI in Oct. 2019 to report suspicious activity regarding its sensitive intellectual property. Quadri had been employed at that company until Sept. 30, 2019.

The suit alleges that Quadri …

EU OKs Moderna COVID-19 vaccine

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

The European Union has authorized the mRNA-1273 COVID-19 vaccine from Moderna (NSDQ:MRNA) ahead of schedule, responding to criticism that it had been too slow in its mass vaccination plans. The E.U. drug regulator had planned on meeting later in the month to discuss the vaccine.

“This vaccine provides us with another tool to overcome the current emergency,” said Emer Cooke, Executive Director of European Medicines Agency (EMA), in a statement. “It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by WHO.”

EMA has also authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) on Dec. 21. It has not, however, given the greenlight to the vaccine from Oxford University and AstraZeneca, which is now available in the U.…

AstraZeneca completes Atacand divestment to Cheplapharm

AstraZeneca (NYSE:AZN) announced yesterday that it completed the divestment of the commercial rights to Atacand to Cheplapharm.

United Kingdom-based AstraZeneca’s Atacand (candesartan cilexetil) is a selective AT 1 subtype angiotensin II receptor antagonist indicated for managing hypertension in adults and children, along with heart failure in adults.

In addition to the commercial rights to Atacand, AstraZeneca is divesting the rights to Atacand Plus, according to a news release. Atacand Plus is indicated for the management of hypertension when candesartan or hydrochlorothiazide monotherapy is not sufficiently effective. Cheplapharm received the commercial rights in over 70 countries throught the agreement.

AstraZeneca developed Atacand in collaboration with Takeda Pharmaceutical, with each company holding exclusive rights to the treatment in certain countries and co-marketing in other countries.

Under the agreement, AstraZeneca received a p…

What are the top COVID-19 vaccine candidates?

This colorized scanning electron microscope image shows SARS-CoV-2 (round blue objects), the virus that causes COVID-19, emerging from the surface of cells cultured in the lab. [Image courtesy of National Institute of Allergy and Infectious Diseases]

As of yesterday, five COVID-19 vaccine candidates had begun Phase III clinical trials as they seek to determine the safety and efficacy of their formulas.

Researchers worldwide are testing 132 COVID-19 vaccine candidates, including 42 that are in clinical trials on humans and at least 92 in preclinical or animal trials, according to the New York Times.

With the U.S. alone topping 200,000 COVID-19 deaths this week and continued pressure to deliver a safe and effective vaccine, these companies and several others are working very quickly to make a vaccine that meets regulatory standards. Seven pharma companies have received funding for vaccine development and…

Report: AstraZeneca Phase III COVID-19 vaccine remains on hold in U.S.

AstraZeneca (NYSE:AZN) is reportedly keeping its COVID-19 vaccine trial in the U.S. on hold as questions remain over patient safety.

U.S. Health and Human Services Dept. Secretary Alex Azar told CNBC yesterday that federal investigators are looking for “answers to important questions,” regarding the safety of patients involved in the trial operated by the United Kingdom-based company in collaboration with Oxford University.

Earlier this month, AstraZeneca voluntarily paused its trial after a standard review process was triggered so an independent committee could review safety data surrounding a single event of an unexplained illness that occurred in the UK Phase III trial for the AZD1222 vaccine candidate. The UK trial has since resumed, but the U.S. study remains paused.

“Look at the AstraZeneca program, Phase 3 clinical trial, a lot of hope. Single serious adverse event report in the United Kingdom, global shutdown and hold of the clinical …

AstraZeneca resumes COVID-19 vaccine trial

AstraZeneca (NYSE:AZN) has resumed its COVID-19 vaccine trial in the U.K. following confirmation from the Medicines Health Regulatory Authority (MHRA) that it was safe to proceed.

The news of the trial resumption, announced Sept. 12, came six days after a voluntary pause so that an independent committee could review safety data surrounding a single event of an unexplained illness. The person with the illness was part of the Phase III trial for the AZD1222 vaccine AstraZeneca is developing in collaboration with Oxford University.

Now that the trial has resumed, AstraZeneca declined to disclose further information.

AstraZeneca is one of nine drug companies that have pledged to ensure safety with a potential COVID-19 vaccine and only submit for approval or emergency use authorization (EUA) after demonstrating safety and efficacy through a Phase 3 clinical study. The companies made the pledge amid worries that there is political pressure in the U.S. to rele…