Russia warns of delays in Sputnik V vaccine supply to Latin America

 Russia's supply of its Sputnik V COVID-19 vaccine to Latin America, a key overseas sales area, may be delayed by up to three weeks as production capacity is ramped up to meet high demand, a blow for countries relying on it for their inoculation programs.

The Russian Direct Investment Fund and the Gamaleya institute said they were expanding capacity to produce more of the vaccine to meet demand in Latin America, where Argentina, Bolivia, Mexico and others are looking to use it.

Global vaccine makers including British-Swedish firm AstraZeneca and U.S.-based Pfizer Inc are battling to boost COVID-19 vaccine production as countries around the world look to protect their populations amid surging infections.

"We are now upgrading facilities located outside of Russia to ensure the supply to Argentina and the rest of the region. As a result, we will see a significant increase in production in the second quarter," RDIF and Gamaleya said in a statement.

"Until then, some batches may have delays of up to 2-3 weeks."

They added that Argentina, one of the first countries to approve the use of Sputnik V, would continue to receive batches of the vaccine, but that there would be an "adjusted schedule."

"We will return to original delivery schedule once the update is complete," they said.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/Russia-warns-of-delays-in-Sputnik-V-vaccine-supply-to-Latin-America-32291466/

Edwards Lifesciences Affirms 2021 Outlook

 Edwards Lifesciences Corp. affirmed its outlook for 2021.

The medical-device company said it still expects adjusted earnings to be between $2 and $2.20 a share. It also still expects between $4.9 billion and $5.3 billion in sales. According to FactSet, analysts are expecting $2.14 in adjusted earnings.

Edwards also said it expects between $1.1 billion and $1.2 billion in sales this quarter. For adjusted earnings, it is expecting between 43 cents a share and 50 cents a share. Analysts are expecting 50 cents a share in adjusted earnings.

https://www.marketscreener.com/quote/stock/EDWARDS-LIFESCIENCES-CORP-12521/news/Edwards-Lifesciences-Affirms-2021-Outlook-32292534/

AstraZeneca to ask Japan's JCR Pharmaceutical to produce COVID-19 vaccine

 

AstraZeneca Plc will license Japanese biotechnology company JCR Pharmaceutical, to produce some 90 million doses of its COVID-19 vaccine to help Japan avoid shortages and delays, the Nikkei newspaper reported.

The government in December agreed to buy 120 million doses of the vaccine developed by AstraZeneca and Oxford University with deliveries to begin in May, the Nikkei said.

Officials at JCR Pharmaceuticals and AstraZeneca's Japan unit were not immediately available for comment outside business hours on Wednesday.

The company produces human growth hormones and a treatment for renal anaemia, among other drugs.

By having the vaccine produced at home, Japan may be looking to avoid potential delays in deliveries. Rollouts of the vaccine have slowed in the European Union after AstraZeneca cut supplies, prompting anger among EU officials.

Japan is likely to begin inoculating its population from the end of February when it is expected to approve Pfizer Inc's vaccine.

It has ordered 75 million doses of that vaccine.

Japan will first vaccinate frontline medical staff and will likely begin inoculating it elderly citizens from April, the minister in charge of the mass vaccination program, Taro Kono, told reporters on Wednesday.

The last major industrialised nation to start giving shots, Japan faces major logistical hurdles that some experts say will make it difficult for it to vaccinate a large portion of its population ahead of the planned start Summer Olympics in Tokyo from July.

https://www.marketscreener.com/quote/stock/JCR-PHARMACEUTICALS-CO--11551531/news/AstraZeneca-to-ask-Japan-s-JCR-Pharmaceutical-to-produce-COVID-19-vaccine-Nikkei-32286563/

Stryker 4Q Net Income Falls; Operating Expenses Rise 12%

 Stryker Corp. reported a drop in profit but slightly higher revenue for the fourth quarter as operating expenses increased from a year earlier.

Net income was $568 million, or $1.49 a share, for the fourth quarter. Earnings a year ago were $725 million, or $1.90 a share.

Adjusted earnings were $2.81 a share. According to FactSet, analysts were expecting $2.55 a share.

Stryker's operating expenses rose 12% from a year ago to $1.97 billion. The company also logged more in other expenses vs. the comparable quarter a year earlier.

Net sales rose more than 3% from a year ago to $4.26 billion. Analysts were expecting $4.33 billion.

https://www.marketscreener.com/quote/stock/STRYKER-CORPORATION-14536/news/Stryker-4Q-Net-Income-Falls-Operating-Expenses-Rise-12-32292285/

WHO Recommends Against Moderna, Pfizer Vaccines for Most Pregnant Women

 The World Health Organization released new guidance about Moderna Inc.'s Covid-19 vaccine this week, recommending generally against the use of the vaccine during pregnancy except in those at high risk of exposure or having a severe case.

"In the interim, WHO recommends not to use mRNA-1273 in pregnancy, unless the benefit of vaccinating a pregnant woman outweighs the potential vaccine risks, such as in health workers at high risk of exposure and pregnant women with co-morbidities placing them in a high-risk group for severe Covid-19," the guidance said. The agency said its recommendations would be updated as more data become available.

The recommendation echoes guidance for Pfizer Inc. and BioNTech SE's vaccine released earlier this month. The WHO said it doesn't recommend pregnancy testing before vaccination, nor does it recommend delaying pregnancy following vaccination. The WHO does recommend that lactating women be offered the vaccines, saying that the shots are unlikely to pose a risk to breast-feeding children.

Covid-19 mRNA vaccines aren't made from live virus, and the mRNA, or messenger RNA -- named after the molecular couriers that deliver genetic instructions -- doesn't itself enter the cell's nucleus and is degraded quickly, the WHO said. Developmental and reproductive toxicology studies in animals haven't shown any harmful effects, the WHO added.

At the same time, there aren't enough data on actual pregnant people to assess the vaccine's effectiveness or risk in pregnancy, the agency said. Pregnant women should be given information and counseling on the lack of safety and efficacy data, it said.

Neither Moderna nor Pfizer enrolled pregnant women in their Covid-19 vaccine trials. Moderna says it plans to establish a registry to study pregnancy outcomes in mothers and infants. Pfizer says it intends to start a maternal vaccine study in the future.

Research has shown that pregnant women are at higher risk of having a severe case of Covid-19 than those who aren't pregnant, and Covid-19 may be associated with a higher risk of preterm delivery. The Centers for Disease Control and Prevention says pregnant people may choose to be vaccinated if they wish, adding that a conversation with a patient's clinical team can help.

https://www.marketscreener.com/quote/stock/PFIZER-INC-23365019/news/WHO-Recommends-Against-Moderna-Pfizer-Vaccines-for-Most-Pregnant-Women-32291385/

Moderna in talks with U.S. to sell 100 million more COVID-19 vaccine doses

 Moderna Inc said on Wednesday it was in talks with the U.S. government to sell an additional 100 million doses of its COVID-19 vaccine that will be delivered in the third quarter of 2021.

https://www.reuters.com/article/us-health-coronavirus-moderna-vaccine/moderna-in-talks-with-u-s-to-sell-100-million-more-covid-19-vaccine-doses-idUSKBN29W1KP

AstraZeneca UK vax partner: Suspicious package made safe, production schedule unaffected

 A suspicious package at an AstraZeneca COVID-19 vaccine plant has been made safe and production schedules of the shots have not been affected, the company Wockhardt UK said on Wednesday.

“We can confirm that the investigation on the suspicious package received today has been concluded. Given that staff safety is our main priority manufacturing was temporarily paused whilst this took place safely. We can now confirm that the package was made safe and staff are now being allowed back into the facility,” Wockhardt UK said in a statement.

“This temporary suspension of manufacturing has in no way affected our production schedule and we are grateful to the authorities and experts for their swift response and resolution of the incident.”

https://www.reuters.com/article/us-health-coronavirus-britain-wockhardt/astrazeneca-uk-vaccine-partner-says-suspicious-package-made-safe-production-schedule-unaffected-idUSKBN29W294