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Could Moderna be authorized as a one-shot vaccine? Here’s what we know – Global News
The head of Ontario’s vaccine distribution task force wants Health Canada to look into allowing Moderna’s vaccine to be administered as one, less effective dose instead of two, allowing his team to ramp up their vaccination schedule across the province.
“We can’t vaccinate people any faster than we can if we don’t have the vaccines to do it,” Hillier said, speaking during a Tuesday press conference.
“I’m not asking Health Canada to change the Moderna from a two-shot vaccine to a one-shot vaccine. What I’m asking is Health Canada have a look at doing that, and saying maybe with the high efficiency that protects you in the first needle, it would be best for the entire population if we went just with a one-shot vaccination program with Moderna. I asked them to have a look at that.”
While provinces are sprinting to get needles into arms as quickly as possible, there is only so much that can be done as Canada awaits the arrival of vaccines.
Ontario came under fire for its initially slow rollout of its first vaccine shipments, but as they prepare to ramp up their vaccination schedule, Hillier says it would be worth studying whether the Moderna vaccine would be effective enough as a single dose.
There are currently two coronavirus vaccines approved for use in Canada, one of which is the Moderna vaccine. The vaccine currently requires two doses administered 28 days apart, with the initial dose providing 80 per cent protection before the second shot jolts that figure up to 95 per cent.
But one thing we don’t know is how long that initial 80 per cent effectiveness would last without a second dose.
The Pfizer-BioNTech vaccine, the only other COVID-19 vaccine currently approved for use by Health Canada, also involves two doses, taken some three weeks apart.
Both vaccines require two doses to hit around 95 per cent protection.
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And because the two dose-regimen is how both vaccines were studied and approved, this is how they must be administered, according to Dr. Zain Chagla.
“We give medications based on a monograph we give them based on how they’re dosed and how they’re studied in clinical trials,” he said.
“And so it’s very hard to then just invent a regimen, in that sense, and hope that it works based on subgroup analysis in a study or how the protocol wasn’t followed in the study.”
Moderna has only received regulatory approval in its two-dose form, meaning Hillier’s dream of a single-shot vaccine would require Moderna to submit new documents indicating the safety and efficacy of a one-dose version — a process that Moderna itself would have to be interested in undertaking.
And that’s also not a given, Chagla said.
“Taking the side of the company, they want their drug to work as best as possible,” he said.
“So I don’t think they’re particularly incentivized to also submit a regimen to Health Canada to say, well, this might work, it might be inferior – only to have their drug not work as well because they didn’t follow the optimal dosing strategy.”
Global News has reached out to Moderna for comment, but did not receive a response by the time this article was published.
Chagla also cautioned that even if Moderna wanted to submit that data, it might not actually exist. That’s because the vast majority of the vaccine recipients in the clinical trials were given two doses, not one.
“That data probably doesn’t exist significantly because, again, most of the people in the Moderna trial got both shots,” Chagla explained.
“And so there is a small subset that missed their (second) appointment…that’s probably not enough to leverage a decision that’s going to be mass vaccination campaign for the population.”
Health Canada’s chief medical adviser echoed Chagla’s comments during a press conference on Dec. 23.
“In terms of the clinical trials for the Moderna vaccine and for the Pfizer vaccine as well, they were both based on a two-dose regimen,” Dr. Supriya Sharma said.
She said that there are measurements of immunity before the second dose that, in the case of Moderna, are “quite high” — but the second dose was still eventually administered, leaving no answer as to whether that immunity drops off and how quickly that might happen.
“The question is how long does that immunity (last) and would it be lasting for that, you know, a significant period of time. So we would recommend that the second dose be given,” Sharma said.
She added that, for the Moderna and Pfizer vaccines, there can be “flexibility” in terms of when the second dose needs to be administered — but there isn’t enough evidence to say just how flexible that timeline might be.
“We haven’t seen anything in the evidence that would show that there would be a significant decrease in immunity if that is delayed for a few weeks. But again, we really don’t have the data to be able to say that, to confirm that one way or the other,” Sharma said.
Chagla said this could be an area where it would be worth investigating further. If it’s discovered that a longer delay between doses doesn’t impact the vaccine’s efficacy, it could help with the vaccine rollout logistics.
“Can we wait two weeks, four weeks and go off the monograph in that sense? Logistically, that might be a whole lot easier — to do people at eight weeks rather than four weeks,” he said.
For the time being, however, the vaccine must be administered as directed.
“The expectation is people get their second dose and…we give them their second dose,” Chagla said.
“We don’t stop doing it just because we want to save supply. We try to get the optimal immunity for the population.”
© 2020 Global News, a division of Corus Entertainment Inc.
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The United States on Thursday raised the pressure on other Group of Seven leaders to share their vaccine hoards to bring an end to the pandemic by pledging to donate 500 million doses of the Pfizer coronavirus vaccine to the world’s poorest countries.
The largest ever vaccine donation by a single country will cost the United States $3.5 billion but Washington expects no quid pro quo or favours for the gift, a senior Biden administration official told reporters.
U.S. President Joe Biden‘s move, on the eve of a summit of the world’s richest democracies, is likely to prompt other leaders to stump up more vaccines, though even vast numbers of vaccines would still not be enough to inoculate all of the world’s poor.
G7 leaders want to vaccinate the world by the end of 2022 to try to halt the COVID-19 pandemic that has killed more than 3.9 million people and devastated the global economy.
A senior Biden administration official described the gesture as a “major step forward that will supercharge the global effort” with the aim of “bringing hope to every corner of the world.” “We really want to underscore that this is fundamentally about a singular objective of saving lives,” the official said, adding that Washington was not seeking favours in exchange for the doses.
Vaccination efforts so far are heavily correlated with wealth: the United States, Europe, Israel and Bahrain are far ahead of other countries. A total of 2.2 billion people have been vaccinated so far out of a world population of nearly 8 billion, based on Johns Hopkins University data.
U.S. drugmaker Pfizer and its German partner BioNTech have agreed to supply the U.S. with the vaccines, delivering 200 million doses in 2021 and 300 million doses in the first half of 2022.
The shots, which will be produced at Pfizer’s U.S. sites, will be supplied at a not-for-profit price.
“Our partnership with the U.S. government will help bring hundreds of millions of doses of our vaccine to the poorest countries around the world as quickly as possible,” said Pfizer Chief Executive Albert Bourla.
‘DROP IN THE BUCKET’
Anti-poverty campaign group Oxfam called for more to be done to increase global production of vaccines.
“Surely, these 500 million vaccine doses are welcome as they will help more than 250 million people, but that’s still a drop in the bucket compared to the need across the world,” said Niko Lusiani, Oxfam America’s vaccine lead.
“We need a transformation toward more distributed vaccine manufacturing so that qualified producers worldwide can produce billions more low-cost doses on their own terms, without intellectual property constraints,” he said in a statement.
Another issue, especially in some poor countries, is the infrastructure for transporting the vaccines which often have to be stored at very cold temperatures.
Biden has also backed calls for a waiver of some vaccine intellectual property rights but there is no international consensus yet on how to proceed.
The new vaccine donations come on top of 80 million doses Washington has already pledged to donate by the end of June. There is also $2 billion in funding earmarked for the COVAX programme led by the World Health Organization (WHO) and the Global Alliance for Vaccines and Immunization (GAVI), the White House said.
GAVI and the WHO welcomed the initiative.
Washington is also taking steps to support local production of COVID-19 vaccines in other countries, including through its Quad initiative with Japan, India and Australia.
(Reporting by Steve Holland in St. Ives, England, Andrea Shalal in Washington and Caroline Copley in Berlin; Writing by Guy Faulconbridge and Keith Weir;Editing by Leslie Adler, David Evans, Emelia Sithole-Matarise, Giles Elgood and Jane Merriman)
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Both the United States and China have pledged large donations of COVID-19 vaccines to countries around the world. Washington has promised 80 million doses, three-quarters of which will be delivered via the international vaccine initiative COVAX, in what has been seen as an effort to counter China’s widening vaccine diplomacy. It began deliveries last week.
China had shipped vaccines to 66 countries in the form of aid, according to state news agency Xinhua. Beijing has not disclosed an overall figure for its donations but Reuters calculations based on publicly available data show at least 16.57 million doses have been delivered. China has also pledged to supply 10 million doses to COVAX.
VACCINES DONATED BY U.S. (plan for the first 25 mln):
Regional partners and priority recipients
COUNTRY/TERRITORY PLEDGED DELIVERED
Including Canada, Mexico, 1 mln to S.Korea in June
South Korea, West Bank and
Gaza, Ukraine, Kosovo,
Haiti, Georgia, Egypt,
Jordan, India, Iraq, Yemen,
United Nations
TOTAL 6 mln 1 mln
Allocations through COVAX
South and Central America
COUNTRY/TERRITORY PLEDGED DELIVERED
Brazil, Argentina, Colombia,
Costa Rica, Peru, Ecuador,
Paraguay, Bolivia,
Guatemala, El Salvador,
Honduras, Panama, Haiti,
Dominican Republic and other
Caribbean Community
(CARICOM) countries
TOTAL 6 mln
Asia
COUNTRY/TERRITORY PLEDGED DELIVERED
India, Nepal, Bangladesh,
Pakistan, Sri Lanka,
Afghanistan, Maldives,
Malaysia, Philippines,
Vietnam, Indonesia,
Thailand, Laos, Papua New
Guinea, Taiwan, and the
Pacific Islands
TOTAL 7 mln
Africa
COUNTRY/TERRITORY PLEDGED DELIVERED
To be selected in
coordination with the
African Union
TOTAL 5 mln
VACCINES DONATED BY CHINA (source – Reuters calculations and official data):
Asia Pacific
COUNTRY/TERRITORY PLEDGED DELIVERED
Afghanistan 400,000
Bangladesh Second batch of First batch of 500,000 delivered
600,000 on May 12
Brunei 52,000 in Feb
Cambodia 1.7 mln as of April 28
Kyrgyzstan 150,000 in March
Laos 300,000 in Feb
800,000 in late March
300,000 in late April
Maldives 200,000 in early March
Mongolia 300,000 in late February
Myanmar 500,000 in early May
Nepal 800,000 in late March
1 mln in early June
Pakistan 500,000 in early Feb
250,000 in Feb
500,000 in March
Philippines 600,000 in late Feb
400,000 in late March
Sri Lanka 600,000 at end March
500,000 in late May
Thailand 500,000 in May
500,000 in June
Timor-Leste 100,000 100,000 in early June
TOTAL 11.052 million
Africa
COUNTRY/TERRITORY PLEDGED DELIVERED
Angola 200,000 in late March
Algeria 200,000 200,000 in Feb
Botswana 200,000 in April
Cameroon 200,000 in April
Congo 100,000 100,000 in March
Egypt 600,000 in March
Ethiopia 300,000 in late March
Equatorial Guinea 100,000 in Feb
Guinea 200,000 in early March
Mozambique 200,000 in late Feb
Namibia 100,000 by early April
Niger 400,000 in late March
Sierra Leone 240,000 by late May
Togo 200,000 in April
Uganda 300,000
Zimbabwe 200,000 in Feb
200,000 in March
100,000 in May
TOTAL 3.74 million
South America
COUNTRY/TERRITORY PLEDGED DELIVERED
Bolivia 100,000 in late Feb
100,000 in late March
Venezuela 500,000 in early March
TOTAL 700,000
Europe & Middle East
COUNTRY/TERRITORY PLEDGED DELIVERED
Belarus 100,000 in Feb
300,000 in May
Georgia 100,000 at end April
Iran 250,000 at end February
Iraq 50,000 in early March
Montenegro 30,000 in early March
North Macedonia 100,000 in May
Syria 150,000 in late April
TOTAL 1.08 million
(Reporting by Roxanne Liu and Ryan Woo in Beijing and Cooper Inveen in Dakar; Additional reporting by MacDonald Dzirutwe in Harare, Asif Shahzad in Islamabad, Gopal Sharma in Kathmandu; Editing by Edwina Gibbs)
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Here’s what you need to know about the coronavirus now:
Australia’s Melbourne to exit lockdown
Australia’s second largest city Melbourne will exit a hard lockdown as planned on Thursday night, Victoria state authorities said, although some restrictions on travel and gatherings would likely remain for another week.
After two weeks in a strict lockdown that forced people to remain at home except for essential business, Melbourne’s five million residents will get more freedom to step outside from 11:59 p.m. local time (1359 GMT) on Thursday.
However, people must stay within 25 km (15 miles) of their homes, officials said, in an effort to stop transmission during an upcoming long weekend. There will also be a total ban on house gatherings and masks will be mandatory indoors.
Deliveries of Thai-made AstraZeneca vaccines delayed
Malaysia and Taiwan are expecting deliveries of AstraZeneca vaccines manufactured in Thailand to be delayed, officials said, the latest countries to report a holdup with orders from the Thai plant.
The delay comes amid concerns over AstraZeneca’s distribution plans in Southeast Asia, which depends on 200 million doses made by Siam Bioscience, a company owned by Thailand’s king that is making vaccines for the first time.
Any questions about Siam Bioscience meeting production targets are sensitive because King Maha Vajiralongkorn is its sole owner. Insulting Thailand’s monarchy is a crime punishable by up to 15 years in prison.
Indonesia aims to speed up vaccinations
President Joko Widodo said on Wednesday he hoped Indonesia’s vaccination rollout will hit one million shots a day by July, as authorities opened up inoculations to anyone aged over 18 in Jakarta to contain increased transmission in the capital.
Health officials in the world’s fourth most populous country, which aims to vaccinate 181.5 million people by next year, are trying to speed up the rollout after facing some supply issues.
The president said he wanted vaccinations to hit a targeted 700,000 doses a day this month and then rise again.
Singapore finds Delta most prevalent among variants
Singapore has found the Delta variant of the coronavirus to be the most prevalent among local cases of variants of concern (VOCs), according to health ministry data, highlighting its level of infectiousness.
There were 449 local cases with VOCs as of May 31, of which 428 were the Delta variant first detected in India and nine of the Beta variant first identified in South Africa.
Singapore reported its 34th death due to COVID-19, taking its toll from the pandemic beyond the 33 casualties recorded during the 2003 Severe Acute Respiratory Syndrome outbreak.
U.S. forming expert groups on lifting travel restrictions
The Biden administration is forming expert working groups with Canada, Mexico, the European Union and the United Kingdom to determine how best to safely restart travel after 15 months of pandemic restrictions, a White House official said on Tuesday.
Another U.S. official said the administration will not move quickly to lift orders that bar people from much of the world from entering the United States because of the time it will take for the groups to do their work.
The groups will be led by the White House COVID Response Team and the National Security Council and include the Centers for Disease Control and other U.S. agencies.
(Compiled by Linda Noakes; Editing by Giles Elgood)
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