Vaccine for COVID-19 close at hand?

It's increasingly likely a vaccine may be close at hand. One encouraging sign: Thousands of volunteers received shots of several candidate COVID-19 vaccines using different "platforms". No death has been reported directly arising from any of the trials. Yes, there had been reports of adverse reactions, and one trial was halted in the UK out of abundance of caution.

The World Health Organization is tracking 196 vaccine studies. Of these, 42 are undergoing clinical trials on humans, and eight are in phase 3 (final, large-scale trials to test safety and efficacy). Out of these platforms -- mRNA, inactivated, live-attenuated, subunit, toxoid, DNA -- experts and ethicists in different jurisdictions will take a call on any individual authorisation.

AstraZeneca and the University of Oxford have developed a vaccine based on a virus taken from chimpanzees, but the trial stopped for a week after one volunteer fell ill – it is continuing in the UK but not the US. Another, Novavax, is launching a larger phase three trial after a study of 10,000 volunteers in the UK.

China and Russia have already approved some vaccines for limited use. The Wuhan Institute of Biological Products has a vaccine being used on health workers in the United Arab Emirates, and says the Chinese government has approved its use in more than 100,000 people.

CanSino Biologics is testing its vaccine on Chinese soldiers. Russian President Vladimir Putin has claimed the Russian Gamaleya Research Institute’s vaccine was approved in August (it wasn’t), named it “Sputnik V”.

The chair of the UK's Vaccine Taskforce, Kate Bingham, says there is a “slim chance” a vaccine might arrive by Christmas. But she expects it to be here by “early next year”. Healthn authority in different jurisdictions must approve any vaccine first, and then it needs to be manufactured and distributed. Pharma firms have already made millions of doses of some of the drugs in trial, but distribution may be more complicated. Many vaccines need to be kept chilled before use.

Who gets it first?

It depends: younger and fitter people who are not essential workers will probably need to wait much longer than frontliners.

Silver bullet?

There are no guarantees vaccines will mean an end to lockdowns. Scientists have stated that the first vaccines may only be partially effective, and may not protect everyone. Flu vaccines are only 50% effective.

Emergency use application filing in US by November

Two American companies expect to apply for emergency approval for their Covid-19 vaccines by late November, welcome news as the US hits a third surge of its coronavirus epidemic and approaches its eight millionth case. Pfizer said Friday it hopes to move ahead with its vaccine after safety data is available in the third week of November, a couple of weeks after the November 3 presidential election.

The announcement means the United States could have two vaccines ready by the end of the year, with Massachusetts biotech firm Moderna aiming for November 25 to seek authorization.

"So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the US soon after the safety milestone is achieved in the third week of November," the company's chairman and CEO Albert Bourla said in an open letter. The news lifted the company's shares two percent in the US. But experts warn that even when vaccines are approved, it will take many months until they are widely available. In any case, they are unlikely to be a good substitute for mask wearing, social distancing and other recommended behavior to curb transmission because we don't know how effective they will be.

Indoor gatherings in colder weather

After falling numbers throughout the summer, the country hit an inflection point in its coronavirus outbreak around the second week of September - with a new daily case average of more than 50,000 according to the latest figures, and the trajectory is upward.

With a shade under eight million confirmed infections and more than 217,000 deaths, America is the hardest-hit country in the world.

The US never came close to returning to its baseline after its first wave in spring, meaning the current spike can be more accurately termed a third surge.

Geographically, the major hotspots are in the Upper Midwest and parts of the Rocky Mountains in the west, while parts of the Northeast that were hit hard in spring are seeing their outbreaks starting to rekindle.

Harvard surgeon and health policy researcher Thomas Tsai told AFP there were multiple factors behind the rising cases - from under testing in the Midwest to authorities failing to monitor the reopening of bars and restaurants and dialing back when necessary.

What's more, "from the contact tracing reports from various municipalities and states, the worry is that the spread is driven now, by indoor social gatherings in people's homes," he added, as the focus of social life shifts from public to private spaces in the colder weather.

One bright sign is that Covid-19 treatments have improved markedly, and since the cases are more spread out than before, hospitals aren't being overwhelmed.

Widespread mask use might also mean that when people do get infected, they have less virus in their body which makes them less sick.

'No magic bullet' 

While vaccines are a crucial tool against the virus, experts have warned they can't be a substitute for behavioral measures like masks and distancing. "It's welcome news that there will be one more thing that can help prevent Covid transmission," said Priya Sampathkumar, an infectious disease doctor and professor at Mayo Clinic.

"But I think we need to be cautious and understand that a vaccine isn't a magic bullet," she added. Pfizer and Moderna, both funded by the US government, launched Phase 3 of their clinical trials at the end of July, and both were producing their doses at the same time.

They aim to deliver tens of millions of doses in the US by the end of the year. Both are "mRNA vaccines," an experimental new platform that has never before been fully approved.

They both inject people with the genetic material necessary to grow the "spike protein" of SARS-CoV-2 inside their own cells, thus eliciting an immune response the body will remember when it encounters the real virus.

This effectively turns a person's own body into a vaccine factory, avoiding the costly and difficult processes that more traditional vaccine production requires.

But while the approach may have helped put Pfizer and Moderna in pole position in the vaccine race, a major drawback is they require deep-freezers for storage, which could limit distribution.

$60 price for Sinovac Covid vaccine offered by Chinese city for emergency use

BEIJING: A Chinese city is offering Sinovac Biotech's experimental COVID-19 vaccine to essential workers and other high-risk groups as part of a national programme for about $60. The eastern city of Jiaxing's center for disease control and prevention (CDC) said in a statement on WeChat that two doses of the vaccine candidate, called CoronaVac, will cost 200 yuan ($29.75) per dose and that vaccinations for key groups including medical professionals have begun.

Chinese authorities have to date not released pricing details for potential COVID-19 vaccines. Hundreds of thousands of people have been given experimental vaccines in late-stage trials as part of an emergency inoculation programme launched in July. It was not clear if Jiaxing city's pricing includes subsidies. The city's CDC declined to comment.

Sinovac did not immediately respond to a request for comment. Its vaccine is in late stage trials in Brazil, Indonesia and Turkey, and the company has said that an interim analysis of Phase 3 trial data could come as early as November. Bio Farma, a state-owned firm in Indonesia which has reached a deal for at least 40 million doses from Sinovac, said this week the vaccine will cost around 200,000 rupiah ($13.60) per dose when it becomes available in the southeast Asian country.

China has said that while reasonable profits for companies are permitted, COVID-19 vaccines should be priced close to cost. China National Pharmaceutical Group (Sinopharm) said in August that a vaccine candidate developed by a unit may cost no more than 1,000 yuan ($148.80) for two shots. An official at China's National Health Commission has said, however, the price will be lower.