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Friday, May 14, 2021

Delayed second Pfizer COVID-19 shot produces more antibodies - study

 Pfizer's COVID-19 vaccine generates antibody responses three-and-a-half times larger in older people when a second dose is delayed to 12 weeks after the first, a British study said. 

  The study released on Friday is the first to directly compare immune responses of the Pfizer shot from the three-week dosing interval tested in clinical trials, and the extended 12-week interval that British officials recommend in order to give more vulnerable people at least some protection quickly. 

  After Britain moved to extend the interval between doses, Pfizer and vaccine partner BioNTech said there was no data to back up the move. However, Pfizer has said that public health considerations outside of the clinical trials might be taken into consideration. 

  "Our study demonstrates that peak antibody responses after the second Pfizer vaccine are markedly enhanced in older people when this is delayed to 12 weeks," Helen Parry, an author of the study based at the University of Birmingham, said. 

  Britain began rolling out Pfizer's vaccine before changing dosing policy, meaning a small number of people who got the shot early received the second shot three weeks later. 

  The study, which has not yet been peer-reviewed, looked at 175 people aged between 80 and 99, and found that extending the second dose interval to 12 weeks increased the peak antibody response 3.5-fold compared to those who had it at three weeks. 

  Antibodies are one part of the immune system, and vaccines also generate T cells. The peak T cell responses were higher in the group with a 3 week interval between doses, and the authors warned against drawing conclusions on how protected individuals were based on which dosing schedule they received. 

  However, taken with data showing good protection against hospitalisation and death from just one shot of Pfizer vaccine, Public Health England said the study was further supportive evidence in favour of Britain's approach. 

  "The approach taken in the UK for delaying that second dose has really paid off," Gayatri Amirthalingam, Consultant Epidemiologist at Public Health England, told reporters. 

https://news.yahoo.com/delayed-second-pfizer-covid-19-230806800.html

Big Promises, Few Doses: Russia Struggling to Make Sputnik V Doses

 Transforming the site of what once was a Soviet-era car factory into a state-of-the-art facility churning out Russia's COVID-19 vaccine Sputnik V was the easy bit.

Making doses in bulk, finding qualified staff and getting equipment have been much bigger headaches for Moscow-based biotech firm R-Pharm and other private Russian companies picked to make the country's flagship shot to fight the pandemic.

President Vladimir Putin has trumpeted the vaccine around the world, and said in March that Russia had signed agreements for the production of 700 million doses abroad.

But Russia had produced just 33 million vaccines as of May 12 and exported fewer than 15 million, according to a Reuters tally that counted each vaccine as consisting of two doses.

Russia's output is much lower than the hundreds of millions being made each month by Pfizer and AstraZeneca.

Interviews with four manufacturers and two people involved in the production process and Russia's supply chain highlight how difficult it is to make Sputnik V and ramp up production.

The problems are a warning to foreign partners - including in India - that are planning to mass produce the vaccine and those countries relying on Moscow to supply their inoculation programmes.

With the United States and European countries focused on vaccinating domestic populations, Russia has stepped in the breach, offering shots to more than 50 countries, from Latin America to Asia.

But delays in getting shots to those countries gives China and the United States time to fill the gap.

In another blow, Brazil's regulator has denied approval to import Sputnik V, citing incomplete data on its safety and efficacy.

The Russian Direct Investment Fund (RDIF), which is responsible for marketing the vaccine abroad, said the manufacturing capacity for Sputnik V was increasing globally as new manufacturers come on board.

RDIF told Reuters it planned to produce enough doses to vaccinate 800 million people in 2021 and that it had "demonstrated its strong commitment to honouring supply contracts".

It said it stood by an offer to provide doses for 50 million people in the European Union. Russia is hoping the vaccine will be approved by the European Medicines Agency.

Russia's health ministry did not respond to a request for comment on production and other problems outlined by manufacturers.

The industry ministry said Sputnik V production was more than meeting the needs of Russia's mass inoculation campaign, and that manufacturers in several other countries, including India and China, were also making the shot.

"Any local issues related to vaccine production are dealt with promptly," it said, adding that the ministry "does its best to ensure that the health system's needs continue to be met in full, and that there is enough vaccine for everyone."

"BLINDFOLDED"

R-Pharm's new 27,000 square-metre (290,000 square-foot) factory on the outskirts of Moscow has more than 200 bioreactors that grow the cells that will form the shots.

R-Pharm was initially learning the process from scratch and operating the bioreactors was like working "blindfolded", chief executive Alexei Repik told Reuters.

"Vaccine production takes around 1-1/2 months or more, for each series," he said. "Then afterwards, you compare the output to the reference sample. If it matches, you're lucky. If it doesn't, you pour out the product you made."

The company has also struggled with global shortages of equipment and raw materials.

R-Pharm was initially gearing up to make 10 million doses a month but by late March had still not produced 1 million doses. It began the process of cell growing in November but its new factory has yet to open officially.

Manufacturers contacted by Reuters said the vaccine was particularly difficult to make because of its design as an adenovirus vector vaccine.

The vectors are modified human common cold viruses, used to carry the genetic information into the body that triggers immunity-building.

Unlike other adenovirus vaccines, the first and booster shots of Sputnik V, taken 21 days apart, are made up of two different vectors and the first shot is easier to produce than the second, manufacturers said.

"The product is difficult enough and you actually have to make two different drugs," said Biocad chief executive Dmitry Morozov, whose company is also making Sputnik V.

In a later comment to Reuters, Morozov said that production had increased sharply in the past month or so, with technical questions resolved and output in the tens of millions of doses.

To deal with the problems, Russia has teamed up with AstraZeneca, whose vaccine uses a different adenovirus shot, two sources familiar with vaccine strategy said. Human trials of a mix-and-match vaccine are under way in several countries.

Another option is "Sputnik Light", a single-dose version of the shot using only the first component.

One private producer, Pharmasyntez, plans to seek permission to produce only the one-dose vaccine, its chief executive, Vikram Punia, said. It sent a first batch for quality controls on May 3.

In response to questions, RDIF said both components of the Russian vaccine were being produced and delivered on time.

LAND AND PEOPLE

A global rush for equipment has increased Russian producers' problems, and pharmaceutical plants are in limited supply in Russia.

Generium, the biggest producer of Sputnik V doses, re-purposed existing plants to work on the vaccine, as did Biocad, the only other major producer.

To expand output, new plants will be needed. Generium is building one to make 200-300 million doses per year, its owner said in March.

The biggest problem for Pharmasyntez's Punia was a lack of experienced staff - producing two doses increases strain on staffing because separate manufacturing spaces and teams are needed.

"We can buy equipment, we can build plants. But in biotechnology, competent people is the most important thing. And there are not very many of them," Punia said.

https://www.usnews.com/news/world/articles/2021-05-14/big-promises-few-doses-why-russias-struggling-to-make-sputnik-v-doses

India's Dr. Reddy's to get 36M doses of Sputnik V vaccine in next few months

Indian drugmaker Dr. Reddy's Laboratories Ltd said on Friday it expects to get 36 million doses of Sputnik V COVID-19 vaccine in the next couple of months under its contract with Russia's sovereign wealth fund.

India's catastrophic second wave of the pandemic has led to huge demand for vaccines, which in turn has left the country, the world's biggest vaccine producer, low on stocks.

"We are in discussions with the Russian Direct Investment Fund (RDIF) to import the vaccine towards the end of May," a senior Dr. Reddy's executive said on a post-earnings press conference.

"Our total commitment contracted from RDIF is 250 million doses, of which the initial 15per cent-20per cent is expected through imports," the executive, M V Ramana, added.

The company expects to use the doses to vaccinate 125 million people in the next 8-12 months. As of Friday, India had vaccinated just over 2.9per cent of its population of about 1.35 billion, according to government data.

Sputnik V is a two-dose shot which has been found to be 91.6per cent effective in preventing people from developing COVID-19, a higher efficacy rate than the two vaccines currently approved in India.

Earlier in the day, Dr. Reddy's said the first dose of Sputnik V was administered in Hyderabad as part of a limited pilot. The vaccine will be priced at 995 rupees (US$13.58) per dose.

The company is also working with six local manufacturing partners to scale up production, with doses for commercial use expected from July.

The drugmaker on Friday reported a 27.6per cent drop in fourth-quarter consolidated net profit, compared with a year earlier. Revenue, however, rose 6.7per cent.

https://www.channelnewsasia.com/news/business/india-s-dr--reddy-s-to-get-36-million-doses-of-sputnik-v-vaccine-in-next-few-months-14809868

WHO urges caution over removing mask mandate for vaccinated people

 The World Health Organization on Friday said local conditions needed to be taken into account if a country is planning to allow vaccinated people not to wear masks in public.

"In the instance of a country that wishes to take away a mask mandate ... that should only be done in the context of considering both the intensity of transmission in the area and the level of vaccine coverage," WHO's top emergency expert, Mike Ryan, told a virtual briefing in Geneva.

The US Centers for Disease Control and Prevention (CDC) on Thursday advised that fully vaccinated people did not need to wear masks outdoors and could avoid wearing them indoors in most places.

The WHO also urged rich countries to reconsider plans to vaccinate children and instead donate Covid-19 shots to the COVAX scheme, which distributes doses to poorer countries.

WHO chief Tedros Adhanom Ghebreyesus also said the second year of the pandemic was set to be more deadly than the first, with India a huge concern.

"I understand why some countries want to vaccinate their children and adolescents, but right now I urge them to reconsider and to instead donate vaccines to #COVAX," he told a virtual meeting in Geneva.

Indian Prime Minister Narendra Modi sounded the alarm over the rapid spread of the coronavirus through India's vast countryside on Friday, as the country's official tally of infections crossed 24 million and over 4,000 people died for the third straight day.

More than 160.71 million people have been reported to be infected by the coronavirus globally and 3,477,379​ have died, according to a Reuters tally.

Infections have been reported in more than 210 countries and territories since the first cases were identified in China in December 2019.

The WHO said it is in touch with the United States about sharing vaccines with the international COVAX scheme.

"They recognise that sharing those doses may help ensure greater impact overall," Bruce Aylward, a senior WHO adviser, told a virtual briefing in Geneva. "They want to be ready when the doses are ready ... We're working in parallel."

https://www.breakingnews.ie/world/who-urges-caution-over-removing-mask-mandate-for-vaccinated-people-1127273.html

Indian variant will become dominant in the UK, top medic says

 The B.1.617.2 variant first found in India will over time surpass the so-called "Kent" variant and become dominant in the United Kingdom, Britain's top medic said on Friday.

"This is more transmissible than the B.1.1.7 (Kent variant), and we expect over time this variant will overtake and come to dominate in the UK, in the way that B.1.1.7 took over," England's Chief Medical Officer Chris Whitty told a news conference.

https://finance.yahoo.com/news/indian-variant-become-dominant-uk-170825250.html

U.S. Officials Hope New Mask Advice Drives Uptick in COVID Shots

 With new federal guidance allowing people to ditch their masks in most places, it will be up to individuals to decide how to protect themselves now that vaccines are readily available, top U.S. health officials said on Friday.

"What we're really doing is empowering individuals to make decisions about their own health," U.S. Centers for Disease Control and Prevention Director Dr. Rochelle Walensky said. "If you are vaccinated and you're making the decision to take off your mask ... you are safe. If you are unvaccinated, then you've made the decision to take that risk."

She said officials were still encouraging unvaccinated people to get their shots as soon as possible to protect themselves and others against the novel coronavirus that is still circulating even as cases decline.

"People who are unvaccinated should not be taking off their masks," Walensky told CBS News' "CBS This Morning" program. In mixed settings where people aren't wearing masks, "It is the vaccinated people who will be protected."

Dr. Anthony Fauci, the nation's top infectious disease official, echoed the idea that looser recommendations should encourage people to get their COVID-19 shots so they can shed their masks.

"Hopefully this will be an incentive for people to get vaccinated," Fauci, U.S. President Joe Biden's chief medical officer, told MSNBC in an interview.

The CDC's official recommendation on Thursday that fully vaccinated people could avoid wearing face masks indoors in most places marked a significant shift toward normalcy for the country, where more than half a million have died in the pandemic over the past year.

There are caveats. The looser mask guidance does not apply to certain situations such as public transportation and prisons. There is also no approved U.S. COVID-19 vaccine for children aged 11 and younger.

Former Food and Drug Administration commissioner and now Pfizer board member Scott Gottlieb told CNBC he backed the new policy given that half the U.S. states had a low case rate of 10 per 100,000 people per day and that vaccination rates were high in many places.

"This is going to provide a pretty strong incentive for a lot of people who were on the fence about getting vaccinated to go out and get vaccinated. I would not be surprised if we see a pretty big bump up in the number of people going out to get vaccinated because now being vaccinated provides more value: you can go around without a mask," he said.

Many states had already relaxed mask mandates and other restrictions in recent weeks as case loads dropped.

While some retail locations may keep masks as a requirement for another two weeks, masks will likely no longer be required there either as we get into June, Gottlieb said.

https://www.usnews.com/news/top-news/articles/2021-05-14/us-officials-hope-new-mask-advice-drives-uptick-in-covid-shots

National Restaurant Association to Stop Urging Masks Indoors for Vaccinated

 The U.S.'s National Restaurant Association will stop suggesting that fully vaccinated people should wear masks indoors, following new advice from the U.S. Centers for Disease Control and Prevention (CDC) on Thursday.

https://www.usnews.com/news/top-news/articles/2021-05-14/national-restaurant-association-to-stop-suggesting-masks-indoors-for-vaccinated-people