DR DOUG QUARRY
In this edition:
1. Janssen/J&J have applied for an EUA for their vaccine. FDA to meet 26 February 2021
2. Russia’s Sputnik V vaccine is 91% effective in preventing COVID-19
3. The place of Sputnik V in international vaccine campaigns
4. Oxford/AZN vaccine 76% effective for three months after single dose
5. The 20-49-year old group accounts for 65% of the US pandemic
6. Vaccine efficacy in pictures
7. Dutch to introduce rapid breath tests for COVID-19
8. Viral load is a leading driver of SARS-CoV-2 transmission
9. Why India’s coronavirus cases are plummeting
10. GSK and CureVac plan second-generation mRNA vaccine to cover variants
11. Recovered COVID patients likely protected for at least six months
12. Coronavirus is in the air – there’s too much focus on surfaces
13. Summary table of Phase 3 trials
14. Canada’s daily vaccination rate now the lowest in the G7
15. Ireland has turned around one of the biggest spikes in COVID-19 cases in the world
16. Biden Administration considering sending masks to all Americans
1. Janssen / J&J have applied for an EUA for their one-shot vaccine
Johnson & Johnson has announced the submission of Application to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of its single-dose Janssen COVID-19 vaccine candidate. The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on 23 February to discuss the submission.
2. Russia’s Sputnik V vaccine is 91% effective in preventing COVID-19
Peer reviewed interim analysis of the Phase 3 trial of Russia’s Sputnik V two-dose vaccine, published in the Lancet, has found the vaccine to be safe and highly effective. Overall, it is 91.6% effective in preventing COVID-19, and was completely protective against severe forms of COVID-19.
The study recruited 21,000 adult participants who either received vaccine or placebo. From day 21 after the first dose of vaccine; 0.1% of participants in the vaccine group and 1.3% in the placebo group were confirmed to have COVID-19. No serious adverse events were found in the vaccine group.
“The suggested lessening of disease severity after one dose is particularly encouraging for current dose-sparing strategies,” reports the study.
3. The place of Sputnik V in international vaccine campaigns
NPR.org published an interview with Judy Twigg, a political scientist at Virginia Commonwealth University.
When asked if Russia had damaged its credibility by approving Sputnik V for emergency use before publishing the data, Ms Twigg answered that now we have several months of data for large-scale administration of the vaccine, the question is now not so much the scientific validity of the vaccine, but more the implications of taking a vaccine from Russia.
Ms Twigg also commented that “Argentina (has) got the first big shipment (of Sputnik V). And now there are dozens of countries that are getting shipments of the vaccine but more importantly are getting licensing and production deals with Russia so that those countries can make the vaccine on their own or buy it from other third-party producers like India.
“This is important because of what’s been labeled the vaccine nationalism that’s been practiced by the rich countries, by the United States and Western Europe, which have enormous pre-purchasing agreements for so much of the existing vaccine that it’s leaving many of the poor and even some of the lower-middle-income and middle-income countries on the sidelines.
“This is a prime opportunity for countries like Russia and China, as well, to exercise some soft power, to gain some diplomatic advantage by moving into this vacuum that’s been created by the lack of supply of some of the Western-generated vaccines.”
4. Oxford/AZN vaccine 76% effective for three months after single dose
Reuters reports that the: “Oxford/AstraZeneca’s COVID-19 vaccine had 76% efficacy against symptomatic infection for three months after a single dose, which increased if the second shot was delayed.
“The findings of the paper, published ahead of peer-review by Preprints with The Lancet, supported Britain’s decision to extend the interval between initial and booster doses of the shot to 12 weeks, Oxford said on Tuesday.
“However, the new study did not address concerns about a lack of data on efficacy among the oldest citizens.
“Andrew Pollard, Chief Investigator of the Oxford Vaccine Trial, said the data showed the 12-week interval between doses was “the optimal approach to roll out, and reassures us that people are protected from 22 days after a single dose”.
5. The 20-49-year old group accounts for 65% of the US pandemic
Science reports a study into the demographics of COVID-19 in the US and UK. The results showed that, as of October 2020, at least 65% of COVID-19 infections in the US originate from individuals aged 20-49.
International SOS Comment: a good understanding of the demographics of transmission is important to steer efforts to combat the pandemic.
6. Vaccine efficacy in pictures
This tweetorial from Natalie Dean** explains how a vaccine’s efficacy can be measured by different parameters:
· Efficacy preventing mild and moderate disease but not infection
· Efficacy preventing mild and moderate disease and infection
***Natalie E Dean: Assistant Professor of Biostatistics at the University of Florida, specializing in emerging infectious diseases and vaccine study design.
7. Dutch to introduce rapid breath tests for COVID-19
Reuters reports that: “The Netherlands is to introduce rapid COVID-19 breath tests to sites across the country to speed up the testing process and make it less intrusive.
“Testing facilities in Amsterdam have started using the SpiroNose, a machine which requires a person to breathe into it to indicate a possible coronavirus infection within a minute.
“After months of trials, Dutch health authorities found the SpiroNose to be reliable in the case of negative test results, infectious disease expert Mariken van der Lubben of Amsterdam’s municipal health services told Reuters.”
8. Viral load is a leading driver of SARS-CoV-2 transmission
There is little information available on which variables affect the risk of transmission of SARS-CoV-2, the development of symptomatic COVID-19, and, particularly, the relationship with viral load.
The Lancet Infectious Diseases has published a study from Spain looking at the distribution of COVID-19 among the close contacts of 314 confirmed cases. There was a total of 753 close contacts and 125 of these became infected.
The likelihood of becoming infected varied according to the viral load in the index case:
· 12% when viral load lower than 1 X 106 copies
· 24% when viral load greater than 1 X 1010 copies
Interpretation
“In our study, the viral load of index cases was a leading driver of SARS-CoV-2 transmission.”
9. Why India’s coronavirus cases are plummeting
The Washington Post reports: “The apparent retreat of the coronavirus in India, the world’s second-most populous nation, is a mystery that is crucial to the future course of the pandemic.
“Just months ago, India was adding nearly 100,000 cases a day — more than any other country.
On 2 January, it reported only 8,635. That’s about the number recorded the same day by New York state, where the population is less than 2 percent of India’s population.
“Epidemiologists in India say that there is only one likely explanation for the decrease in new cases: the virus is finding it harder to spread because a significant proportion of the population, at least in cities, has already been infected.
“The decline is not related to a lack of opportunity for transmission. India has fully reopened its economy, with elementary schools being the only major exception. Restaurants, malls and markets are bustling.”
“Just months ago, India was adding nearly 100,000 cases a day — more than any other country.
On 2 January, it reported only 8,635. That’s about the number recorded the same day by New York state, where the population is less than 2 percent of India’s population.
“Epidemiologists in India say that there is only one likely explanation for the decrease in new cases: the virus is finding it harder to spread because a significant proportion of the population, at least in cities, has already been infected.
“The decline is not related to a lack of opportunity for transmission. India has fully reopened its economy, with elementary schools being the only major exception. Restaurants, malls and markets are bustling.”
10. GSK and CureVac plan second-generation mRNA vaccine to cover variants
BioSpace reports that: ”GlaxoSmithKline (GSK) will partner with Germany’s CureVac to manufacture 100 million doses of the company’s mRNA COVID-19 vaccine.
GSK will also collaborate with Curevac to develop a next-generation multi-valent COVID-19 vaccine aimed at emerging variants of the novel coronavirus.
Curevac’s vaccine candidate is currently undergoing Phase 3 trials in Germany and Belgium.
11. Recovered COVID patients likely protected for at least six months
A major study by UK Biobank, which has followed volunteers since 2006, has found that almost all people previously infected with COVID-19 have high levels of antibodies for at least six months and that these are likely to protect them from reinfection.
Among participants who had tested positive for previous COVID-19 infection, the results showed that 99% retained antibodies to SARS-CoV-2 for three months. After the full six months of follow-up in the study, 88% still had antibodies.
“Although we cannot be certain how this relates to immunity, the results suggest that people may be protected against subsequent infection for at least six months following natural infection,” said Naomi Allen, a Professor and Chief Scientist at the UK Biobank.
12. Coronavirus is in the air – there’s too much focus on surfaces
An Editorial in Nature.com has focused on their assessment that “SARS-CoV-2 is transmitted predominantly through the air – by people talking and breathing out large droplets and small particles called aerosols. Catching the virus from surfaces – although plausible – seems to be rare.” (See E. Goldman Lancet Infect. Dis. 20, 892–893; 2020)
The article quotes the most recent public guidance, updated last October, from the World Health Organisation (WHO): “Avoid touching surfaces, especially in public settings, because someone with COVID-19 could have touched them before. Clean surfaces regularly with standard disinfectants.”
Importantly, the Editorial Committee say: “This lack of clarity about the risks of fomites – compared with the much bigger risk posed by transmission through the air – has serious implications. People and organizations continue to prioritize costly disinfection efforts, when they could be putting more resources into emphasizing the importance of masks, and investigating measures to improve ventilation. The latter will be more complex but could make more of a difference.”
13. Summary table of Phase 3 trials
Eric Topol*** has updated his table summarizing Phase 3 results for four vaccines (J&J not included). An “endpoint” in a study is a defined outcome in a participant, such as proven infection. Most important is the “Severe” (endpoint) column. Only one “severe” outcome is noted on the vaccine arm of all trials.
14. Canada’s daily vaccination rate now the lowest in the G7
Canada’s low daily vaccination rate is interesting given that it has the largest vaccine portfolio per capita.
15. Ireland has turned around one of the biggest spikes in COVID-19 cases in the world
16. Biden Administration considering sending masks to all Americans
In tweet from Eric Topol***
*** Eric Topol is a Professor of Molecular Medicine at The Scripps Research Institute, and a senior consultant at the Division of Cardiovascular Diseases at Scripps Clinic in La Jolla, California. He is Editor-in-Chief of Medscape and theheart.org.
