COVID-19 Vaccine Can Turn People Into "Crocodiles", Says Brazilian President Bolsonaro

 "In the Pfizer contract it's very clear: 'we're not responsible for any side effects.' If you turn into a crocodile, it's your problem," Jair Bolsonaro said on Thursday.

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World News/Covid-19 Vaccine Tracker: Brazilian President Jair Bolsonaro has launched an attack on coronavirus vaccines, even suggesting that the one developed by Pfizer-BioNTech could turn people into crocodiles or bearded ladies.

The far-right leader has been sceptical of the coronavirus since it first emerged late last year, branding it "a little flu." in the week he insisted he wouldn't be vaccinated, even while launching the country's mass innoculation program.

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"In the Pfizer contract it's very clear: 'we're not responsible for any side effects.' If you turn into a crocodile, it is your problem," Bolsonaro said on Thursday.

That vaccine has been undergoing tests in Brazil for weeks and is already getting used within the united states and Britain.

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"If you become superhuman, if a woman starts to grow a beard or if a man starts to speak with an effeminate voice, they will not have anything to do with it," he said, pertaining to the drug manufacturers.

When launching the immunization campaign on Wednesday, Bolsonaro also said it might be free but not compulsory.

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But the Supreme Court on Thursday ruled that the vaccine was obligatory, although couldn't be "forced" on people.

That means authorities can fine people for not being vaccinated and ban them from certain public spaces, but not force them to take it.

Brazil has recorded quite 7.1 million cases and almost 185,000 deaths from Covid-19 amongst its 212 million population.

Bolsonaro said that when a vaccine has been certified by Brazil's regulatory authority Anvisa, "it will be available for everyone that wants it. But me, I won't get vaccinated."

"Some people say I'm giving a bad example. But to the imbeciles, to the idiots that say this, I tell them I've already caught the virus, I have the antibodies, so why get vaccinated?"

There are alittle number of cases of apparent reinfection although there's no certainty over whether an individual are often reinfected or how long immunity lasts.

Bolsonaro caught the virus in July but recovered within three weeks.

Brazil is within the middle of a second wave of coronavirus infections.

After peaking in June to August cases had been dropping but that changed in November.

On Thursday, Brazil surpassed 1,000 daily deaths from covid-19 for the first time since September.

The country's immunization program has been widely criticized for being late and chaotic, not least given Bolsonaro's opposition.

Pfizer wants approval for emergency use in India after UK

 Pfizer Inc submitted application to DCGI seeking emergency use authorisation on Dec 4; also seeks permission to import vaccine for sale and distribution in India.

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World News/Covid-19 Vaccine Tracker: Pfizer has become the primary company to seek emergency use approval of its vaccine candidate in India after getting clearance within the UK and Bahrain. Pfizer Inc and BioNTech SE vaccine candidate, BNT162b2, has shown 95 per cent efficacy against coronavirus during a preliminary clinical trial data analysis. It's sought approval from the Drugs Controller General of India for emergency use authorisation. the development is significant since Prime Minister Narendra Modi, during an all-party meet on Friday, cited experts to mention that India could have the first coronavirus vaccine in weeks and that eight vaccines are going to be manufactured in India.

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Pfizer, in its application submitted on December 4, has sought permission to import the vaccine for sale and distribution in India. It also sought the waiver of clinical trials on Indian population as per the special provisions under the New Drugs and Clinical Trials Rules, 2019, to urge instant approval for emergency use, a PTI report said.

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"Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorisation (EUA) for its COVID-19 vaccine in India," an official source told the press agency .

AIIMS Delhi Director Dr Randeep Guleria had earlier said that India was in talks with Pfizer-BioNTech regarding its COVID-19 vaccine candidate. He said no such communication had been initiated with Moderna for its experimental COVID-19 vaccine.

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The UK became the first country within the world to approve Pfizer and BioNTech coronavirus candidate on December 2 after the Medicines and Healthcare Products regulatory agency (MHRA) found the jab safe. The country has already ordered 40 million doses of the Pfizer vaccine to vaccinate its 20 million population. After the united kingdom , Bahrain has also approved the vaccine for 'emergency use'. Bahrain's drug regulatory body said the approval was granted after a radical analysis and review of all available data.

The approval for Pfizer's vaccine candidate came in just 10 months since it started developing it, which is that the fastest within the history of vaccines. Other countries just like the US and the European Union also are vetting the Pfizer and BioNTech candidate and the one developed by Moderna Inc. 

Notably, Pfizer, BioNTech, Moderna, and Russia's Sputnik V are the sole vaccines that have claimed over 90 per cent efficacy of their respective candidates so far. While Russia had already rolled out Sputnik V for the masses in August, the recently announced data results on the efficacy of Moderna, Pfizer, and BioNTech's vaccines have also raised high hopes. Besides, Swedish drugmaker AstraZeneca and therefore the University of Oxford's vaccine candidate, being developed along side India's Serum Institute, has also achieved 70 per cent efficacy during the preliminary analysis of its Covid-19 trial participants.

Russia vaccine to be made in India:100 million doses of effective Sputnik V will be made every year, production will start next year

 

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• India's pharmaceutical company Hetero ties up with Russian Direct Investment Fund

• Sputnik V free in Russia, for other countries its price will be less than 700 rupees

India News/Covid-19 Vaccine Tracker: The Russian Direct Investment Fund (RDIF) and India's pharmaceutical company Hetero have tied up to produce Corona's vaccine Sputnik V. This agreement is to make 100 million doses every year in India. Production will start from next year.

Sputnik V has been created by the Gameleya National Research Center for Epidemiology and Microbiology of Russia. RDIF is overseeing its production and promotion abroad. The clinical trial for the third phase of the vaccine has been approved. These trials are ongoing in many countries including Belarus, UAE, Venezuela. According to IDIF, the second and third phase trials are going on in India.

More than 50 countries have requested to make 120 million doses of this vaccine. The vaccine will be produced in India, China, Brazil, South Korea and other countries for supply in the global market.

'Big step in the fight against Corona'

Murali Krishna Reddy, Director, International Marketing, Hetero Labs Ltd, said Sputnik V is most effective in treating Kovid-19. We are very pleased with this partnership with RDIF to develop the vaccine. This partnership is another step towards fulfilling our commitment and the Make in India campaign in the fight against Corona.

At the same time, RDIF CEO Kirill Dmitriev said that we are happy to announce the agreement with Hetero. This will pave the way for the production of safe and most effective corona vaccine in India. Thank you for partnering with Hetero. This will help us to increase the production capacity and provide a better solution to the people of India in this challenging period of Corona.

Hetero has over 25 years of experience

Hyderabad based company Hetero is India's leading generic pharmaceutical company. It was founded in 1993 by Dr. BPS Reddy. It is the world's largest manufacturer of anti-retroviral drugs for the treatment of HIV / AIDS. The company has over 25 years of experience in the pharmaceutical industry. Hetero's business spans 126 countries.

95% effective Sputnik vaccine

Sputnik has proven to be 95% effective in fighting corona during a trial. The second preliminary analysis of the clinical trial showed that 42 days after the first dose, it showed 95% efficacy. The data was 91.4% 28 days after the dose was given.It will also cost much less than other vaccines. People of Russia will get it for free. For other countries, its price will be less than 700 rupees.

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US Plans to Starts Covid vaccinations by 11 December: Official

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World News/Covid-19 Vaccine traker: The united states hopes to start a sweeping program of Covid vaccinations in early December, the head of the govt coronavirus vaccine effort said Sunday.

"Our plan is to be able to ship vaccines to the immunization sites within 24 hours of approval" by the US Food and Drug Administration, Moncef Slaoui told CNN.

"So I expect maybe on Day Two of the approval, on the 11th or the 12th of December."

FDA vaccine advisors reportedly will meet december 8 to 10 to discuss approving vaccines which Pfizer and Moderna say are a minimum of 95 percent effective.

Two leading vaccine candidates -- one by Pfizer and German partner BioNTech and another by US firm Moderna -- have shown to be 95 percent effective and Pfizer already applied to emergency use approval from US health authorities.

Meanwhile, Pfizer Inc applied to US health regulators on Friday for emergency use authorization (EUA) of its COVID-19 vaccine, the first such application during a major step toward providing protection against the new coronavirus.

The application to the U.S. Food and Drug Administration (FDA) comes just days after Pfizer and German partner BioNTech SE reported final trial results that showed the vaccine was 95% effective in preventing COVID-19 with no major safety concerns.

Pfizer Chief executive officer Albert Bourla confirmed the application had been made in a video posted on the company's website on Friday afternoon.

The FDA said on Friday it might hold a meeting of the advisory committee on December 10 at which members would discuss the vaccine.

Slaoui estimated that 20 million people across the US may be vaccinated in December, with 30 million per month after that.

US drug regulators on Saturday already gave emergency approval to a Covid-19 antibody therapy -- one used by US President Donald Trump -- and G20 nations were pushing for global "equitable" access to vaccines with worries poorer nations will be left behind.

The US, which recorded 177,552 new infections on Saturday, is now averaging almost 110,000 more daily cases than a month ago. Recently, US FDA approved an antibody cocktail from Regeneron Pharmaceuticals Inc. for coronavirus treatment.

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Pfizer wants emergency use of its COVID-19 vaccine in US

 The action comes days after Pfizer Inc and its German partner BioNTech announced that its vaccine appears 95 per cent effective at preventing mild to severe COVID-19 disease during a large, ongoing study.

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World News/Covid-19 Vaccine: Pfizer said Friday it's asking US regulators to permit emergency use of its COVID-19 vaccine, starting the clock on a process that might bring limited first shots as early as next month and eventually an end to the pandemic -- but not until after a long, hard winter. The action comes days after Pfizer Inc and its German partner BioNTech announced that its vaccine appears 95 per cent effective at preventing mild to severe COVID-19 disease in a large, ongoing study.

The companies said that protection plus a good safety record means the vaccine should qualify for emergency use authorization, something the Food and Drug Administration can grant before the ultimate testing is fully complete.

In addition to Friday's FDA submission, they have already started "rolling" applications in Europe and therefore the UK and intend to submit similar information soon.

With the coronavirus surging round the US and therefore the world, the pressure is on for regulators to make a speedy decision.

"Help is on the way," Dr Anthony Fauci, the top US infectious disease expert said on the eve of Pfizer's announcement, adding that it's too early to abandon masks and other protective measures. "We need to actually double down on the public health measures as we're waiting for that help to come."

Friday's filing triggers a sequence of events because the FDA and its independent advisers debate if the shots are ready. If so, still another government group will need to decide how the initial limited supplies are rationed out to anxiously awaiting Americans.

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How much vaccine is available and when is a moving target, but initial supplies will be scarce and rationed.

About 25 million doses of the Pfizer vaccine may become available in December, 30 million in January and 35 million more in February and March, according to information presented to the National Academy of medicine this week. Recipients will need two doses, three weeks apart.

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